Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview The Manager of Supply Chain and Logistics plays a crucial role in supporting both the commercial and clinical supply chains at Insmed. The primary focus is on managing import/export requirements and collaborating with third-party logistics companies. This position involves serving as the main point of contact for partners, ensuring on time, compliant, day-to-day shipment management, monitoring vendor performance through KPIs, and tracking budgets. The role also requires contributing to build and maintain Insmed's master data management practices, as well as implementing and monitoring DSCSA compliance initiatives. This is a non-supervisory position This role oversees vendors and/or contractors Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Strategic Planning Collaborate with senior leadership and cross-functional teams to develop and implement strategic plans for the supply chain and logistics operations. Identify and assess potential risks in the supply chain and propose mitigation strategies. Vendor Management Establish and maintain strong relationships with third-party logistics companies and other relevant vendors. Oversee day-to-day interactions with vendors, ensuring adherence to contractual agreements and performance expectations. Monitor and analyze vendor management key performance indicators (KPIs). Shipment Management Oversee the day-to-day management of shipments, ensuring timely and accurate deliveries. Implement tracking systems to monitor the progress of shipments and address any issues that may arise. Implement quality control measures to ensure the integrity and safety of shipped products. Investigate and address any deviations from quality standards in collaboration with relevant teams. Budget Tracking Develop and manage budgets for supply chain and logistics operations. Monitor expenditures, identify cost-saving opportunities, and ensure financial objectives are met. Import/Export Compliance Ensure compliance with all import/export regulations and requirements. Stay informed about changes in international trade regulations and implement necessary adjustments to the supply chain processes. DSCSA Compliance Demonstrate expertise in the Drug Supply Chain Security Act (DSCSA) requirements. Implement and oversee compliance measures to ensure the traceability and security of pharmaceutical products throughout the supply chain. Master Data Management Utilize experience with master data management to ensure accurate and consistent data across the supply chain systems. Implement and maintain data governance practices to enhance data quality and reliability. Qualifications Qualifications Bachelor's degree in Supply Chain Management, Logistics, Business, or a related field. Master's degree is a plus. Proven experience (5 years) in supply chain and logistics management, preferably in the biotech or pharmaceutical industry. Skills Strong understanding of import/export regulations and compliance. Experience with master data management practices. Familiarity with DSCSA regulations and compliance. Demonstrated experience in managing third-party logistics companies and vendor relationships. Excellent project management and organizational skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills for cross-functional collaboration. Proficiency in relevant software and technology, including supply chain management systems. #L #LI-KM #LI-Hybrid Travel Requirements Able to travel up to 10% (Domestic and/or International) Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $108,000.00 to $150,667.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

Sr Director Program Management

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview Reporting to the Vice President of Program Management, the candidate will be responsible and accountable for the coordination and leadership of activities associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program management support to provide end-to-end oversight of the program strategy and management for initiating, planning, executing, controlling, reporting, and terminating the Integrated Development Plan and associated functional plans. As a leader, the Sr. Director of Program Management will provide cross-functional operational and program management leadership, strategic thinking, and business acumen for the development programs for products or devices in a global, matrix organization, from Research to life cycle management. Additionally, the Sr. Director of Program Management will work with the Program Management team and global organization to design new processes and supporting business structures and recommend new and global solutions that drive process standardization and simplification across the company. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Contribute to the success of the Project Management Organization (PMO) in achieving its goals & objectives by ensuring program work is conducted in compliance with PMO processes and Company policies and leading organizational and program management processes. Drive implementation of key program documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and other key tools to improve organizational processes. Challenge the organization to be innovative, make it safe to try new approaches, and take prudent risks. Coach the team to bounce back quickly from disappointments and learn from mistakes. Drive process improvements across the functions. Be accountable for the alignment between the Global Asset Team (GAT), Functions and Portfolio plans such that the forecasted benefits of the program are achieved. Find opportunities for leveraging investments and creating value, including external innovation or partnerships. Establish Global Asset Team (GAT) strategies with goals & objectives in alignment with functional, geographic, and organizational objectives. Ensure the development of program plans are in alignment with corporate strategy, and that the plans are tracked and managed. Work with respective functional leaders to drive the creativity of innovative product target profiles and product development plans that optimize value, time, resources and risk while ensuring that program strategy is aligned with business objectives. As the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and recommendation through proactive communication to the teams and Senior Leaders. Drive teams to meet or exceed goals by providing superior global cross-functional leadership and management in a matrix organization, driving decision making, facilitating issue resolution, problem-solving, risk management, contingency planning and decision-making. Lead and direct integrated teams to plan, execute, control, report and close-out all program related work across all functions (e.g., integrated program budget, risk, timeline, resource, and stakeholder management). Other projects and assignments, as required. Qualifications Bachelor degree in a scientific, medical or business discipline. An additional/post-graduate qualification will be a distinct advantage (Ph.D., MBA etc.). 10-15 years of Project/Program Management experience with proven management and/or leadership experience in an R&D, manufacturing/operations or commercial context in a biotech/bio-pharmaceutical environment required. Project Management Professional (PMP) certification a plus but not required. Strong interpersonal skills with the ability to influence without authority, motivate with enthusiasm and develop productive working relationships with key stakeholders. Entrepreneurial, self-starter with a proven track record of success in fast-paced and demanding environment and strong desire to "make things happen", including a results-oriented work ethic and a positive, can-do attitude. Must be an experienced pharmaceutical/biotechnology program/project manager with experience in leading drugs through all phases of development and into commercialization. Must be a team player with the highest of personal values and ethical standards. Must have excellent leadership and interpersonal skills; should be an effective team leader who can manage and lead in a matrix environment. Strategic thinker with excellent problem-solving skills and an ability to influence all levels of the company. An ability to take hands-on, "roll up your sleeves" approach toward achieving business results. Ability to quickly gain credibility and confidence with all levels within the company. Well-developed computer skills (e.g., MS Project, Excel, PowerPoint, SharePoint). #LI-KM #LI-Hybrid Travel Requirements Willing to travel within the US and overseas. Travel expected to be ~ 5-10%. Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $200,000.00 to $280,000.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

Senior Clinical Trial Associate

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview Assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Works with global cross - functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines, government regulations, etc. Provides operational support for the Clinical Operations team with heavy focus on study start - up activities, patient recruitment efforts, maintenance, and study closure deliverables. Participates in the creation and distribution of study materials, including essential documents, presentations, and reports. Assists with the tracking and documenting of site and sponsor training (e.g., study specific, drug, program, and therapeutic area level), and maintains training matrices for the clinical study team. Actively participates in clinical study team and vendor Schedules meetings, drafts and finalizes meeting agendas and action items. During clinical study team meetings, provides updates on health and currency of study TMF, and document tracking and currency, tracks and maintains cohesive list of protocol deviations. Reviews CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical Provides cross - functional support for inspection readiness preparations. Helps coordinate the retrieval of documents and coordination of other activities, as necessary. Participates and helps maintain study operations planning, risk assessment and mitigation strategies, and reviews and helps ensure level of detail and adherence to study's RACT tool. Responsible for the QC activities of the Sponsor - and CRO - supported TMF at intervals specified in project plan and/or applicable SOPs and/or prior to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts. Responsible for the collection of essential documents and maintenance of both paper and electronic Trial Master Follows up with CROs, and/or functional area representatives on pending/outstanding documentation in accordance with TMF metrics. Assists in preparing TMF Health Reports and collecting TMF status updates and TMF metrics Participates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and other site/vendor Assists in the review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms. Assists with the training and mentoring of newly hired CTAs, as appropriate. Qualifications Bachelor's degree in the life sciences, healthcare, and/or related field is Minimum of 3+ years of progressive experience in a Clinical Operations Experience considered relevant includes clinical and/or basic research in a bio/pharmaceutical company, Academic Research Organization (ARO), Contract Research Organization (CRO), etc. Experience in rare disease and/or orphan indications is preferred. Demonstrated knowledge of budgetary and financial practices including review and tracking of budget and forecast, opening and tracking activities of purchase orders, payment tracking and process for external parties. Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology, FDA and local regulatory requirements, etc. Proven experience with TMF, both paper and electronic (eTMF) preferred, including Solid understanding of the DIA TMF Reference Strong familiarity with study start - up activities, including feasibility, country and site activation, patient recruitment Experience with collaborating with CROs and third - party vendors to ensure successful and quality execution of studies, and builds strong working relationships to create strong team alliances. Applies clear and consistent performance standards, and handles problems decisively and objectively with quality and detail - oriented with high standards. Ability to interact with all global cross - functional team members to coordinate/execute study Proactively initiates before asked to assist by colleagues, team members and/or Demonstrated good communication (verbal and written), conflict management, skills, and highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Demonstrated ability to train and mentor/ new hires and colleagues, as needed Must successfully exhibit Insmed's five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competencies/ Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. Travel Requirements Up to 10% , domestic and/or international travel may be Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $116,000.00 to $161,333.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

SPEM - SEC

Infosys Limited, Bridgewater

Infosys is seeking a Senior Practice Sales Director for its Cyber Security practice. As a Senior Practice Sales Director, you will be helping to sell in Fortune 2000 companies on Cyber Security solution and services. You will be responsible for pipeline building and lead generation, client conversations, GTM campaigns and will be managing end to end deal life cycle with the help of pre-sales and delivery teams. You will also have the opportunity to shape value-adding solutions that enable our clients to meet the changing needs of the global landscape.About Infosys Cyber Security PracticeThe cybersecurity industry's response has been a call to embrace Zero Trust Security which means not trusting anything trying to connect to the organization's systems without verification. Recently, we successfully moved 80% of our global employees to securely work remotely. Our strategy was to move to remote working by design, securing it at scale and for future. We are re-imagining Cyber Security by creating platforms, working with tech OEMs and partnership with academia.To learn more about Infosysand see our ideas in action please visit us at www.infosys.comRole Description:Client relationship management - Managing relationships with client personnel;Client delivery assurance: collaborate with all delivery stakeholders involved to ensure fulfilment of all commitments to the client;Account planning and governance: create the account plan including relationships required, opportunities to be pursued, price decisions, etc.Required Qualifications:Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education and 14+ years of experience, with strong sales/relationship management/account management experienceSignificant business development and project management experienceExperience selling cyber security solutionsHands-on experience with proposal creation and leading proposal presentationsStrong leadership, interpersonal, communication and presentation skillsWide variety of IT and business consulting engagement experienceU.S. citizens and those authorized to work in the U.S. are encouraged to apply, we are unable to sponsor this position at this timePreferred Qualifications:Knowledge of industry specific go-to-market solutionsGood understanding of industry specific business issues and driversGlobal Delivery Model experienceExperience managing large multi-location consulting engagement teamsTrack record as an Account Manager in a rapidly growing client relationshipAbout UsInfosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.Infosys is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.

Manager Benefits

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview This role supports the Sr. Director, Total Rewards to manage the U.S. benefit plan administration. The Benefits Manager administers, implements, maintains and develops benefit programs, policies and procedures. Requires monitoring of the various plans and policies to ensure compliance with legal requirements and company objectives. This is a hands-on role requiring a strong level of attention to detail, customer service, communication skills and requires the flexibility to manage a variety of work independently. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Demonstrate comprehensive understanding of U.S. benefits plans, including but not limited to group medical, dental, vision, life insurance, short- and long-term disability, Health Savings Accounts, Flexible Spending Accounts, various voluntary benefit offerings, 401(k), and well-being benefits. Ensure familiarity with contracts, benefits policies, and procedures Assist employees with questions, directing them to appropriate to resources and escalating vendor or other complex issues. Support the implementation, roll out and delivery of new benefits/programs, and employee communications. Manage monthly benefit plan invoicing; verify the calculation of the premium statements for all group plans and submit and track timely payment. Manage absence and leaves of absence administration; work with third-party administrator ensuring that leaves and disability programs are being administered timely, accurately and in accordance with leave documentation; c ommunicate leave of absence policies to employees and managers; support Workday absence and leave configuration for statutory requirements; maintain complete and accurate records to include any impact to payroll deductions and benefits payments. Partner with legal department to ensure compliance with various federal, state, and local leave legislation and mandates. Develop leave administration process changes and implement them as needed in response to changes in legal requirements. Develop employee communications in partnership with our Corporate Communications group to optimize communication platforms/media; develop and execute communications to increase employee awareness, participation, and understanding of a variety of benefit plan programs and initiatives (open enrollment, well-being, new plans, plan changes, plan documents,etc.) :provide benefit education opportunities to employees through either internally developed materials or partnering with vendors or broker resources. Support the development and administration of a variety of programs related to the company's overall well-being initiatives. Support the management of wellness programs and preventive health events and develop creative and effective communication to drive employee participation at such events and focus on personal wellness in a variety of ways. Partner with wellness vendors and supervise on-site wellness activities; plan , schedule, and host HQ health-related events for employees (flu-shot clinic, on-site screenings etc.). Actively participate in all Open Enrollment (OE) activity, including the development of communication materials, data auditing, ensuring completeness of the process and appropriate Payroll set up. Support 401(k) plan administration with non-discrimination testing, annual audit, and distribution of required disclosures Maintain an understanding of current, new, and developing legislation and trends affecting employee benefit programs; recommend changes to ensure continued compliance and value and implement as approved. Support compliance activities including but not limited to ACA, ERISA, HIPPA, ADAAA, ACA, SECTION 125 requirements. Ensure distribution of required employee notices and plan documents. Maintain benefit documentation for all carriers (contracts, invoices, COBRA, employee benefit/wellness guide), ensure filing of 5500's and distribution of benefit summaries as required Engage with third-party vendor resources such as brokers, carriers, and other to ensure smooth administration of company benefits plans. #LI-JT1 #LI-Hybrid Qualifications 5 years Benefits Administration experience. Advanced knowledge of all pertinent federal and state regulations, filing and compliance requirements, including the ACA, ERISA, COBRA, FMLA, ADA, Section 125, Medicare, and Social Security and DOL requirements. Experience in the day-to-day operation of US Health & Welfare plans Experience managing US leaves of absence, California specific experience a plus Effective planning and priority setting and project management experience Able to work at a detailed level to complete or review analysis and develop recommendations, but also look at the big picture Critical analytical skills to identify, investigate and correct issues; collect data, establish facts, draw valid conclusions, recommend corrective change where appropriate. Strong customer focus with the ability to partner with and develop trusting relationships with stakeholders, including but not limited to employees, managers, Legal and HR Business Partners, and to communicate complex issues in an understandable way. Ability to provide timely, accurate response to confidential/sensitive requests and handle confidential and sensitive discussions Strong interpersonal, verbal & written communication skills; ability to interact effectively with all levels of employees and management. Ability to manage multiple tasks and/or priorities with strong attention to detail and high level of accuracy Self-motivated with proven ability to work independently with a high level of confidentiality and discretion Proficiency with MS Excel, PowerPoint, and Word Workday experience is preferred Education Bachelor's degree in Human Resources Management, or another related area of expertise CEBS or CBP preferred #LI-KM #LI-Hybrid Travel Requirements Up to 5% travel based on vendor requirements Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $108,000.00 to $150,667.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

Sr Director Quality Assurance Operations

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA and QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers. This is a supervisory position with 3-6 individual direct reports. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Responsible for final product Quality release/rejection and related processes. Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA. Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply. Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & procedures Lead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc Provide oversight of QC equipment program, which includes qualification, calibration, PM, etc Review and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operations Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP). Responsible for QA representation in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects. Manage the performance and development of 3-6 direct reports. Support supplier and internal audits as necessary. Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc. Act as company's representative during regulatory agencies and customer inspections. Supports the investigation of product and related CAPAs. Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department. Support Statistical Trending of Manufacturing and Analytical Data. Additional duties as assigned Qualifications BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance. Commercial drug manufacturing site QA head experience preferred Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness. Ability to solve complex problems and take proactive action Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual. Maintain professionalism, self-motivation, and enthusiasm. Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing. Must perform statistical analysis and capable of analyzing data to solve problems Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines Solid knowledge of all QC laboratory equipment and manufacturing equipment Direct experience with investigations and root cause analysis in pharmaceutical or medical device products. Experience with internal and external audits. Experience reviewing manufacturing and QC validation documents. Preferred ASQ CQE and CQA Certifications. Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971. Demonstrate ability to manage projects and variable workloads. Excellent communication and coaching skills (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). Travel Requirements Up to 30% travel, both domestic and/or international. Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $200,000.00 to $280,000.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

AEM, LS

Infosys Limited, Bridgewater

Infosys is seeking an Associate Client Partner for its Life Sciences vertical. The person will lead all client interfaces within the assigned account scope, and along with the Client Partner / Senior Client Partner build an account plan for the client management. Usually, the person handles either a single account or part of a large account with an indicative annual book of business of up to $10-$30 million.Role Description: • Client relationship management and business development: lead client relationships, build a portfolio up to $10-30M, lead the opportunity management cycle: Prospect-Evaluate-Propose-Close• Client delivery assurance: collaborate with all delivery partners involved to ensure fulfillment of all commitments to the client.• Collaborate with the Delivery Manager to address all people or infrastructure related issues that may be affecting the delivery of the project vis-à-vis the specific client.• Balance different projects running for the client that may involve different delivery managers or horizontal unit resources.• Take go-to-market solutions to accounts and drive revenue from go-to-market solutions being sponsored by the business unit.• Work closely with the Solutions Leader to build customized solutions pitches for the target account and driving the revenues and delivery of these solutions.• Account planning and governance: build the account plan including relationships required, opportunities to be pursued, price decisions, etc.• Craft account plan with details of the relationships required, the opportunities that have to be chased, and forecasting the potential revenue yield from such opportunities, as well as potential threats and weaknesses that need to be addressed.• Make pricing decisions within the scope of the Master Services Agreement.• Support pre-sales proposals for new business development outside of account scope.• Provide vital input for building future alliances with relevant product vendors.About Infosys Life Sciences:Infosys is helping pharma companies focus on their objectives by leveraging a futuristic, rapid response, and deeply automated foundation that provides vital insights to enable meaningful execution. Create new capabilities that allow for the unprecedented flow of information, deliver value through connectedness, and transform into new business models. Drive continuous improvements by learning powerful digital skills and gaining experience through innovation ecosystems.Required Qualifications:• Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education and 7+ years of experience, with strong sales/relationship management/account management experience• Significant business development and project management experience • Experience in the relevant industry/vertical• Track record of interacting and building relationships with CXO level client contacts• Hands-on experience with proposal creation and leading proposal presentations• Strong leadership, interpersonal, communication and presentation skills• Wide variety of IT and business consulting engagement experience• U.S. citizenship or permanent residency required; we are not able to sponsor this position at this timePreferred Qualifications:• Knowledge of industry specific go-to-market solutions• Good understanding of industry specific business issues and drivers • Global Delivery Model experience• Experience managing large multi-location consulting engagement teams• Track record as an Account Manager in a rapidly growing client relationshipAbout Us:Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.Infosys is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability

Manager Regulatory Operations

Insmed Incorporated, Bridgewater

EM, FS

Infosys Limited, Bridgewater

Infosys is seeking a Client Partner for its Financial Services vertical. The person will lead all client interfaces within the assigned account scope and along with the Senior Client Partner / Group Managers build an account plan for the client management. Usually, the Client Partner handles a single account or part of a large account with a P&L of $30MM to $50MM.Role Description: • Client relationship management and business development: manage client relationships, build a portfolio up to $30-40M, own the opportunity management cycle: Prospect-Evaluate-Propose-Close • Client delivery assurance: collaborate with all delivery stakeholders involved to ensure fulfillment of all commitments to the client• Account planning and governance: create the account plan including relationships required, opportunities to be pursued, price decisions, etc.• Provide client introductions, and customer context to internal teams. Navigate the account to identify varied kinds of deals; form and lead pursuit teams, recommend & defend the winning price, understand client drivers and competitor moves, interface with client on expectations, develop account plan, review and follow it.• Drive MSA / SOWs/payments (AR), resolve delivery escalations and complaints, and mentor IBU account team to demonstrate business value to the client.• Maintaining the Infosys price premium, enhancing client satisfaction, and growing the account as per the account plan WITHIN the assigned account.About Infosys Financial Services:Infosys Financial Services (FS) practice is a thriving macrocosm. Our IT solutions for financial services contribute to nearly one-third of the company's revenues. What has not changed after all these years, however, is the fact that at our core, we still intend to redefine the way banks use technology. Today, 'Digitization' is the name of the modern game and Infosys FS is at the forefront of this movement. The biggest trend defining the global financial services industry is digital disruption.Infosys embraces highly scalable and easily integrated IT solutions for capital markets. We implement highly scalable, secure target IT architecture that helps clients adapt to the change, be leaner, and achieve business agility. Infosys leverages its key competencies to successfully deliver digital transformation programs for the clients in capital markets domain.Required Qualifications:• Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education and 11+ years of experience, with strong sales/relationship management/account management experience• Significant business development and project management experience• Experience in the relevant industry/vertical• Track record of interacting and building relationships with CXO-level client contacts• Hands-on experience with proposal creation and leading proposal presentations• Strong leadership, interpersonal, communication, and presentation skills• Wide variety of IT and business consulting engagement experience• U.S. citizenship or permanent residency is required; we are not able to sponsor this position at this timePreferred Qualifications:• Knowledge of industry-specific go-to-market solutions• Good understanding of industry-specific business issues and drivers• Global Delivery Model experience• Experience managing large multi-location consulting engagement teams• Track record as an Account Manager in a rapidly growing client relationshipAbout Us:Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.Infosys is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.

Manager Learning Development

Insmed Incorporated, Bridgewater

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview The Manager, Learning & Development role will design and develop engaging, innovative, and impactful learning experiences to enable the development of our organization now and in the future. This role is responsible for creation of learning solutions that span the 70:20:10 and leverage multiple modalities to bring learning to life in the flow of work. The Manager, Learning & Development will collaborate with stakeholders across the organization, leveraging data, insights, and feedback to identify and address leadership and power skill development needs. Collaboration and creativity are critical in this role to support a culture of learning and develop user-centric learning experiences that enable our employees and leaders to grow and thrive in their careers at Insmed. Responsibilities Responsibilities Apply adult learning theory and design thinking to design, develop, pilot and deliver engaging and effective learning experiences utilizing a variety of modalities, methods, and toolsSource, develop and customize content from a variety of internal and external sources (including LinkedIn Learning) to address organizational learning needsAssess organizational learning needs to ensure learning solutions developed are aligned with organization goals and strategyChampion a culture of learning at Insmed, including support for the use of innovative learning experiences, such as social learningLeverage strong collaborative partnerships with internal subject matter experts to incorporate insights, feedback and Insmed culture into learning solutions to effectively close capability gapsEffectively project manage learning projects to deliver effective content or solutions on time and on budgetCoordinate with external vendors to develop learning solutions in line with Insmed culture and organization needsUtilize creativity and design skills to create course assets and communications that are engaging and compellingContinuously innovate and improve learning design and approach by staying ahead of learning & development industry trends, tools, and technology, including AIAnalyze reporting and evaluation of learning solutions to ensure effectiveness, positive impact, and strong ROIAct as Learning Administrator for Workday Learning (LMS), ensuring a positive learning experienceQualificationsBachelor's degree in Human Resources, Organization Development, Education, or other related field required5+ years of related Learning & Development experience required, with a focus on LX/instructional design; prior experience in Pharma and/or Biotech a plusDemonstrated experience designing and developing learning programs and related assets in multiple synchronous and asynchronous modalities, including instructor-led learning, eLearning, and social learningExperience designing learning solutions for a cross-functional, multi-level Global audienceHighly proficient in Articulate 360, Vyond, Adobe Creative Suite, Microsoft Office 365 suite, and other learning/content development toolsExcellent verbal and written communication skillsStrong project management skills, with a proven ability to manage multiple projects simultaneouslyKnowledge of adult learning, instruction design methodology and tools, design thinking and current L&D trendsExceptional attention to detail and follow through, with ability to be flexible and adapt to in a fast-paced, evolving environmentAbility to cultivate relationships, consult and collaborate across all levels and functions within a global organizationAbility to maintain a high level of confidentialityExperience with Learning Management Systems or Learning Experience Systems; prior experience with Workday Learning a plus#LI-JT1#LI-Hybrid Travel Requirements Less than 10% travel Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $108,000.00 to $150,667.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan withcompanymatch Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established . The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.