Applications Project Manager Salary in Bridgewater, NJ

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.

The Senior Estimator/Preconstruction Manager will be responsible for:Reporting directly to the Director of EstimatingWorking hand-in-hand with the Project Management teamGrowing the business through connections and business developmentGenerating conceptual, schematic, lump sum, GMP, design development, and other types of estimatesCreating and maintaining strong relationships with repeat/potential clientsAttend meetings and contribute to presentationsMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Senior Estimator/Preconstruction Manager will be responsible for:5+ years of experience as an EstimatorAn experienced Estimator that can jump in and do the job right awayInterior/renovation experience in one of their disciplinesWill consider the right person from a subcontractor background

The Construction Estimator will be responsible for:Reporting directly to the Director of EstimatingWorking hand-in-hand with the Project Management teamGrowing the business through connections and business developmentGenerating conceptual, schematic, lump sum, GMP, design development, and other types of estimatesCreating and maintaining strong relationships with repeat/potential clientsAttend meetings and contribute to presentationsMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Construction Estimator must have:5+ years of experience as an EstimatorAn experienced Estimator that can jump in and do the job right awayInterior/renovation experience in one of their disciplinesWill consider the right person from a subcontractor background

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.

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.

Job Summary:As Data Analytics Program Manager, you will enable Messer US to leap from data to data-driven decisions and analytics. This role will manage a diverse portfolio of Sales & Marketing, Customer Service, OTC Analytics projects, leading high-profile initiatives, and collaborating with cross-functional teams and IS - Information Systems to ensure awareness, alignment, project management, commitment and while delivering business results via Analytics.Why Messer?Messer is the world's largest privately held industrial gases company and what we do matters because it is woven into every part of life, from the medical gases that patients rely on to the essential elements needed to safely and sustainably produce the goods our communities depend on.The true strength of Messer is our people-at every level and in every role.Join us and take pride in the impact you will make by providing solutions essential to our world and lives. Reach your highest potential at our stable, inclusive company with diverse opportunities in a growing industry, supported by people who care.Messer stands apart because we put what matters first, and you matter.Principal Responsibilities:As a key leader in the Sales & Marketing organization, this position is responsible for defining and driving the Data and Analytics vision, architecture and roadmap for US Bulk Business.Responsible for managing Messer's Sales & Marketing Data & Analytics agenda which includes: Sales, Marketing, Sales Performance, Customer Service, Order to Cash, including directly managing 3rd Party providersResponsible for establishing and driving standards in Data and Analytics practices and technologies for the Sales and Marketing organization.Responsible for providing internal consultancy to the Messer business to drive the exploitation of Data and Analytics technologies, to deliver business requirements. Responsible for timely resolution of incidents and 1st level support for Data and Analytics technologies, delivered through a team of strong team of Data AnalystsResponsible for supporting full lifecycle implementation and project management of new Data and Analytics solutions to the business, working in collaboration with other IS application and infrastructure teams;Responsible to be part of a Business Intelligence Community to ensure strategic governance, adoption of best practices and ongoing capability development;Be a champion for the value of Messer's Data & Analytics roadmap, communicate effectively with key stakeholder at all levels in the organizationResponsible to manage and optimize processes for data intake, validation, and engineering as well as modeling, visualization and communicating deliverablesRequired Skills:Project Management - manage Analytics roadmap and project managementLeadership and influential skillsCustomer focusTime management and prioritizationCommunication skillsCritical thinkingAccuracy and precisionProblem solvingQualifications:Must Have:Bachelor's degree in appropriate functional area (expert / equivalent professional experience in Business and IT roles can be considered in lieu of Bachelor's degree)7+ years' experience in support of SAP BW 7.5 requiredExperience in Data Analytics- data analysis, data modeling, statistics, trends, reporting,SAP ECC requiredExperience in SAP HANA requiredSAP DWC and SAP SAC required Nice to Have:Experience in SAP BO desirableMicrosoft SQL Server experience desirableSAP Datasphere- SAP Data Warehouse Cloud (DWC) and SAP Analytics (SAC) preferredAbout Messer:Messer's safety culture, commitment to providing dependable supply and innovative gas technology solutions help customers unlock opportunities to be safer, more sustainable, more productive and more efficient, so their business thrives. We nurture lasting, meaningful relationships with customers, our communities, and with one another.We offer comprehensive benefits and appreciable pay, with steady schedules and opportunities for ongoing training and career progression. We prioritize and invest in our people at every level of our organization - the dedication, knowledge, customer focus and entrepreneurial spirit of our employees is what make Messer refreshingly different.If you need assistance with the application or would like to request accommodation, call (877) 243-1030.

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, Regulatory Operations will be responsible for functional activities related to US/Ex-US regulatory submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission related documents in the Company's electronic document management system (EDMS). Responsibilities RESPONSIBILITIES: Support regulatory submission activities associated with generating electronic submissions in support of IND/NDA applications. Responsible for the archival of submission and submission related documents in the EDMS Contribute to submission planning to identify pending submissions and define priorities. Anticipate upcoming tasks based on the submission timelines. Perform quality control checks and coordinate comment resolution with publishing team. Support authors to complete regulatory documents such that all components are provided and presented in the correct format. Manage document review and approval as needed. Assists with other projects to support the regulatory department as assigned. Provide support in software validation and migration activities relating to new or existing systems in Regulatory Affairs Required Skills 5 years of Regulatory Operations experience Extensive knowledge and experience with Microsoft Office, Adobe Acrobat, Veeva RIM, DocuBridge eCTD Publishing software, DXC Toolbox, WebTrader, Extedo eSubmanager Effective/productive working with minimal supervision Detail oriented Strong written and verbal communication skills Ability to multitask and prioritize when working on multiple projects and deliver on tight timelines within a fast-paced team environment. Flexible in managing shifting priorities. 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.

Description: Reporting to the Director of ESG Programs and Reporting and sitting on the global ESG Team: this Manager will support the implementation of the company's ESG strategies. This Manager will work across all three workstreams: preparation of sustainability data for reporting and assessments; implementation of ERG strategy and amplification of the business' social impacts; and continuous process improvement and creation of documentation and governance structures. The person who will succeed in this role will enjoy building, influencing and making their mark on the full breadth and depth of an ESG function. This role is based in Bridgewater, New Jersey and offers a hybrid working schedule of being onsite for 3 days per week. Essential Functions: Environmental:  Strategy: support the development, deployment and stakeholder buy-in for an enterprise level sustainability strategy, action plans, goal setting and targets. Filing Requirements: understand the different global regulatory frameworks and support the ESG and Finance teams with preparation of data, strategy and risk related materials.  Change Management: guide and influence stakeholders across the business in forging new mindsets and behaviors around sustainability data management and processes. Project Management: of new sustainability initiatives and ESG assessments from customers from ideation through to successful execution. Stakeholder Management: join the cross-functional Sustainability Data Taskforce, and partner with teams (Finance, Legal, Internal Audit, IT, Operations and Supply Chain) across the business to prepare the company for filing.  Community Management: chair the recurring AmnealEarth meetings, and encourage global employee participation. Social: Scaling ERGs: guide our global ERG leaders and committees to deepen and embed their impact, events and messaging in alignment with enterprise DEIB strategy. External Communications & Promotion: partner with the Communications, Media Relations and Investor Relations teams to promote the company’s impact on communities and the healthcare sector. Governance: Data Governance: leverage enterprise level, systems thinking to optimize and standardize data management processes, approvals and workflows to create accurate, timely and verifiable datasets that will be subject to auditing and assurance.  Educating & Presenting: to cross functional stakeholders and subject matter experts to align business leaders under a common vision and long-range agenda. Internal Reporting: prepare quarterly ESG dashboards for executives on key sustainability metrics, trends and action plans.   Education: Bachelors Degree (BA/BS) Bachelor's degree from a four-year college or university or equivalent combination of education and cross functional business experience. - Required Master Degree (MBA) Preferred MBA or equivalent graduate qualifications. - Preferred Experience: 6 years or more in any combination of management consulting, sustainability, corporate social responsibility and/or project management experience. Ideally with experience in healthcare/pharmaceuticals managing global sustainability data and reporting with a publicly listed or privately held US company, who completed voluntary ESG disclosure. Skills: Education and awareness raising across the business and with key stakeholders - Intermediate Meticulous data governance, documentation and process delivery - Advanced Strategic, systems thinking with ability to synthesize and recommend efficiencies and synergies - Intermediate Accurate preparation of materials for submission to government authorities - Advanced Project management from ideation through to execution - Advanced Strong written and verbal communication, including exemplary presentation skills - Advanced Change management, stakeholder management and influencing capabilities - Intermediate Commercial acumen and application of enterprise level problem solving - Intermediate Partnership with key internal stakeholders including Finance, Legal, Internal Audit, IT, Operations, Supply Chain and Communications - Intermediate Partner with sustainability vendors and firms to co-create results - Intermediate Prepare company for assessment, audit and assurance requirements - Intermediate Specialized Knowledge: Global sustainability regulatory requirements Greenhouse gas emissions, measurement and reduction targets Corporate sustainability strategy and assessments Corporate social responsibility and philanthropy Diversity, equity, inclusion and belonging strategy implementation

SummaryThis position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. Education and Credentials• Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.• RAC certification or other equivalent is preferred.Experience• Minimum Bachelor's degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience, at least 3 years of regulatory CMC experience with US product development. • Deep knowledge of US and EU regulations for biosimilars is preferred.• Deep knowledge of regulations for drugs and biologics.• Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.• Experience in various regulatory submissions and communication with regulatory agencies. Hosted communication with the agencies on clinical development plans, clinical design and other clinical aspects (including document package writing, meetings and discussions with the agency, etc.) is preferred.• Led at least one drug IND application in US and get it approved. Experience in endocrine drugs such as insulin and GLP-1 is preferred.• Experience in working in multi-culture/multi-countries environment is preferred.Skills• Demonstrated ability to manage multiple and diverse projects concurrently.• Demonstrated ability to develop positive relationships and collaborations.• Strong analytical skills; a strategic thinker, planner, and implementer.• Ability to operate independently with minimal supervision. • Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.ResponsibilitiesActively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package;Participate as Global Product Strategy Lead in cross-functional teams, including but not limited to, contract research organizations (CROs), functional working groups, global regulatory team, submission team, product development team, to ensure compliance with regulatory requirements;Author Module 2 and 3 documents for regulatory filings such as INDs/ IMPDs/ CTAs/ MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards.Drive the preparation and review of regulatory submissions, such as INDs, BLAs, MAAs, meeting packages to ICH member Health Agencies, and supplemental filings ensuring regulatory documents are written per guidelines and timelines.Manage and track filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates.

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.