- Genmab (NJ)
- …we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position… more
- Merck & Co. (Rahway, NJ)
- …Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory ... Job DescriptionAssociate Director , Business System Labeling Management Required experience and...and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... development of regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct the development… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Novo Nordisk Inc. (WA)
- …and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy . Other internal relationships include a dotted line with ... in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex...from other departments (Corporate Tax, MA, Comm'l BUs, Medical, Regulatory , Legal, etc) Assigned policy areas may… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... Director will lead franchise programs, and will be the...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Merck & Co. (Rahway, NJ)
- …action development plans of personnel under their direction within the framework of Company policy . The Executive Director will be a manager of managers, with ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional teams, including sales, marketing, medical affairs, market access and policy /advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, ... pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Brief Description of Duties: Under the supervision of the City Administrator, the Director of Community Development is an exempt position under FLSA. Ensuring that ... independent judgement and simultaneously considering the financial, ethical, legal and regulatory variables that affect the City is vital. Performs complex and… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Identifies ... of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Continuously… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and ... credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry, and to… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... in inspection management. Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. Demonstrated… more
- Repligen (Waltham, MA)
- …company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting processes including ... with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC filings and tax regulations for… more
