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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. 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Sr Director Quality Assurance - Pharmacovigilance
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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 of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP). Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME) and act as company's representative during regulatory agency inspections and vendor audits. Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities are conducted, reports written according to SOPs and that QEs/CAPAs are written, reviewed and followed up. Structure and conduct internal Pharmacovigilance systems audits Supports the evaluation and acceptability of Pharmacovigilance vendors for potential use and provides direction, guidance and strategicconsultation for the company. Conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE's/CAPAs. CQA representative for review of PV SOPs/WIs, PSMF, SDEA's, JOGs and other PV related documents. Supports strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks. Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources. Qualifications: Minimum BS degree in Chemistry or related life sciences discipline required with minimum 10-15 years of experience, 7 years of which are in Pharmacovigilance. Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered. Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing. Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required. Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required. Experience developing SOPs, reviewing internal pharmacovigilance, clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential. CQA representative on weekly/monthly pharmacovigilance meetings. Ability to organize and conduct internal audits is necessary. Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs. Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice. Must successfully exhibit Insmed's five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration. #LI-KM #LI-Hybrid Qualifications M #LI-Hybrid Travel Requirements Ability to travel both domestically and internationally, approximately 25%-30%. 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. 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Assistant Manager, Merchandising - Bridgewater Promenad
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About Old Navy Forget what you know about old-school industry rules. When you work at Old Navy, you’re choosing a different path. From day one, we’ve been on a mission to democratize fashion and make shopping fun again. Our teams make style accessible to everyone, creating high-quality, must-have fashion essentials for the whole family, with love, season after season. We opened our first store in 1994 in San Francisco and have been on a roll ever since. We cultivate a community of playful personalities that thrive in a fast-paced environment where our employees can be their most authentic selves. Here, we’re family.About the RoleIn this role, you will set the tone for the store team and help bring our brand to life for our customers and employees. Your leadership role is critical in supporting the execution of the store strategy to achieve performance goals and drive profitable sales growth through all aspects of the store, including; customer and product operations, merchandising, and talent development. Through collaboration with your leadership team, your goal is to teach others and coach behaviors to cultivate a high performing team that meets or exceeds goals.What You'll DoAll leaders are expected to become experts of the brand's selling behaviors, leading and leveraging these behaviors with every customer who walks through our doors and allowing us to provide a exceptional customer experience.Recruit, hire and develop people to drive a culture of high performance and engagementAccountable for team performance through teaching, coaching and providing meaningful feedback to build capabilitiesSupport strategies and processes using a customer centric mindset to deliver results, drive store sales, and maximize efficiencies and productivityPromote community involvementAdapt team priorities to respond to customer and business partner needsProvide front line supervision to an operational, service or administrative teamWho You AreProvides clear and direct communication of expectations and gives feedback while listening to learn in order to unlock personal and business resultsProven ability to organize and utilize time management and prioritization skills to effectively manage multiple tasks in an environment with competing demandsStrength in driving metrics to deliver results that will meet or exceed business goalsAble to travel as requiredProbe beyond the stated situation, uses reporting and company tools to find identify underlying issues and considers possible alternativesGood understanding of concepts and procedures within own subject areaBenefits at Old Navy Merchandise discount for our brands: 50% off regular-priced merchandise at Old Navy, Gap, Banana Republic and Athleta, and 30% off at Outlet for all employees. One of the most competitive Paid Time Off plans in the industry.* Employees can take up to five “on the clock” hours each month to volunteer at a charity of their choice.* Extensive 401(k) plan with company matching for contributions up to four percent of an employee’s base pay.* Employee stock purchase plan.* Medical, dental, vision and life insurance.* See more of the benefits we offer. *For eligible employeesGap Inc. is an equal-opportunity employer and is committed to providing a workplace free from harassment and discrimination. We are committed to recruiting, hiring, training and promoting qualified people of all backgrounds, and make all employment decisions without regard to any protected status. We have received numerous awards for our long-held commitment to equality and will continue to foster a diverse and inclusive environment of belonging. In 2022, we were recognized by Forbes as one of the World's Best Employers and one of the Best Employers for Diversity.US CandidatesPlease note that effective, June 30, 2022, Gap Inc. will no longer require any of its employees to wear face masks or require proof of COVID vaccination, unless required by local or state/provincial mandates or as part of Gap Inc's quarantine guidelines after being exposed to or testing positive for COVID. Therefore, please disregard any language in any job posting that refers to Gap Inc.'s face mask and proof of vaccination policy as said policy is no longer effective.
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.
Project Manager - Hospitality, Restaurant, Retail
Michael Page, Bridgewater
Project Leadership: Lead the overall planning, execution, and successful delivery of ground-up hospitality and multifamily projects on the South Shore. Manage project teams, contractors, and stakeholders to ensure efficient progress and adherence to quality, budget, and timeline goals.Project Planning: Develop comprehensive project plans, including budgets, schedules, and resource allocation. Coordinate with architects, engineers, and other professionals to ensure accurate and detailed project documentation.Financial Management: Monitor project budgets, expenditures, and cost control measures. Collaborate with the finance team to provide accurate financial forecasts and analysis throughout the project lifecycle.Contract Negotiation: Negotiate contracts and agreements with subcontractors, suppliers, and vendors. Ensure compliance with company policies, regulations, and legal requirements.Stakeholder Management: Build and maintain strong relationships with clients, architects, engineers, and other project stakeholders. Regularly communicate project updates, address concerns, and ensure client satisfaction.Quality Control: Implement and oversee quality control measures to ensure adherence to project specifications and industry standards. Conduct regular site inspections to monitor progress, identify issues, and propose effective solutions.MPI 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.Bachelor's degree in Construction Management, Civil Engineering, or related field (Master's degree preferred)Minimum of 5 years of experience as a Project Manager, preferably in ground-up hospitality and multifamily projectsProven track record of successfully delivering projects on time, within budget, and meeting quality standardsStrong knowledge of construction management principles, processes, and best practicesExcellent leadership skills with the ability to motivate and guide project teamsProficiency in project management software and toolsExceptional communication and interpersonal skillsAbility to travel to project sites as required
Senior Manager Commercial Analytics Respiratory
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 Senior Manager, Commercial Analytics, Respiratory will be a key member of the Commercial Effectiveness organization, responsible for generating, analyzing, and supporting Directors of Commercial Analytics with transforming data into an actionable perspective of the business. The incumbent will collaborate with various cross-functional teams, including Marketing, Sales, and FP&A, to understand and utilize data to deliver a proactive perspective on the business. Responsibilities Perform ongoing and ad-hoc analytics to track product performance as well as support Directors of Commercial Analytics in driving analyses for upcoming launches (e.g., understanding market landscape, patient journey, customer needs, HCP characteristics, payer landscape)Leverage custom/syndicated datasets to track and help explain product performanceAccountable for helping to craft an objective and proactive view of product and market performance Support the Director of Commercial Analytics with adhoc requests to prepare for launch Partner closely with other Commerical Effectiveness team members and cross-functional teams to ensure analyses encompass key learnings across the business Develop expertise in relevant therapeutic areas, related commercial products, and assets in development to ensure accurate data interpretation Become a trusted partner to members of the Commercial Effectiveness team as well as internal stakeholders Ensure cross-functional communication and alignment to maximize impact of insights on business strategy Qualifications:5+ years of experience in commercial analytics with 3+ years within the biopharmaceutical industry required (mix of education and experience also considered)Rare disease / specialty / respiratory experience preferredProduct launch experience preferredBachelor's degree requiredMBA or other advanced degree (MS, PhD) preferredProven record of success through teamwork and execution Solid understanding and expertise in conducting analyses with the goal of garnering actionable insights Experience with data tools, such as SQL, Python, and Excel; programming skills with SQL Ability to understand different data sets (marketing data, sales, claims, access etc.) to utilize in building models to answer key business questions; a bility to build predictive models that provide strategic insights Ability to make the complex simple; adept at translating complex analytical results into compelling business storiesExcellent collaborative, consultative and solution-minded approach to working across multiple functionsProactivity in mining and understanding data interdependencies and trendsSelf-motivated, with a sense of urgencyCan persuade and influence others; manage conflict appropriatelyStrong and agile team player able to adapt and execute based on evolving business needsExcellent communication (verbal and written) and project management skills Highly organized with a strong attention to detail, clarity, accuracy and concisenessMust successfully exhibit Insmed's five (5) core values of: Collaboration, Accountability, Passion, Respect and Integrity, along with any other position specific competencies.Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace Travel Requirements Up to 20% 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 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.
Manager Regulatory 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 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. Travel Requirements 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 $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.#LI-JK1
Manager Supply Chain Logistics
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 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.#LI-JK1