- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Merck & Co. (Rahway, NJ)
- …, Mentoring Staff, People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, ... Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development teams, and executive management.Establishes strong cross-functional and… more
- Merck & Co. (Rahway, NJ)
- … development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and ... verification testing strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design,… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on… more
- Insmed Incorporated (NJ)
- …meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all ... device combination product development at various development stages and product lifecycle management.Stay current with regulatory guidelines and industry… more
- Merck & Co. (Rahway, NJ)
- …functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality, Compliance , Supply Chain and Commercial. Understanding of product ... (VCM) is the accountable organization for our company's Manufacturing Division product supply chain strategy in alignment with Global Human Health brand/franchise… more
- Insmed Incorporated (NJ)
- …medical team.Experience partnering with the HEOR group.Proven understanding of legal, regulatory , and compliance policies.Demands a keen understanding of ... of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible...- Dermatology role will be responsible for supporting the product through its life cycle for hidradenitis suppurativa (HS)… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance , Medical Affairs, Market Access, and Commercial ... of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP...business partner to identify and manage HCP resourcesBe a product champion and maintain knowledge of therapy areasEnsure a… more
- Genmab (NJ)
- …his/her specified region/division to meet and exceed all sales goals while maintaining compliance with field sales activity. The Director will develop the ... compliance with corporate policies and procedures and applicable regulatory and legal standards and requirementsRequirements:Bachelor's degree; Advanced degree a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader responsible for the management, development, and performance of… more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance , Medical Affairs, Market Access, Advocacy, and Commercial ... and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib program in HS (hidradenitis… more
- Merck & Co. (North Wales, PA)
- …Marketing, Global digital data and analytics, PDT/Research & Development, Policy, Regulatory , Legal/ Compliance teams, and other relevant stakeholders, to ... experienced, motivated, and passionate commercial talent to serve as the Executive Director , US Commercial Leader, for our Ulcerative Colitis Indication within our… more
- Merck & Co. (Durham, NC)
- …strategic maintenance and reliability projects. The Mechanical Services Engineer Associate Director (AD) position will ensure reliable performance of equipment by ... responsible for aligning maintenance projects with the business objectives around Safety, Compliance , and Cost.- The Mechanical Services Engineer AD must be able to… more
- Eisai, Inc (Nutley, NJ)
- …career evaluation, coaching, mentoring, performance management and talent review. Ensure compliance with regulatory and other ethical guidelines relevant to ... profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership,...Development teams for support of clinical studies across the product portfolio. Works closely with his/her direct reports in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Lead efforts to optimize call center workflows, implement ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management… more
- Merck & Co. (Rahway, NJ)
- …activities-ensuring integration of HF principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Rahway, NJ)
- …lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal ... relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology, Technical Product… more
- Merck & Co. (Rahway, NJ)
- …risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. ... Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development...rigor and drive risk understanding and reduction prior to product launch. The packaging development lead will be accountable… more
- Merck & Co. (Millsboro, DE)
- … product release, aseptic operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead ... teams, and who works effectively across functional partners.Quality- and compliance -focused with practical experience supporting regulatory inspections,… more
