- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director, Regulatory Affairs - Regulatory Project Management (RPM) ... planning and drives coordination of global and US regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL),… more
- Merck & Co. (Lower Gwynedd, PA)
- …The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development ... (AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience with ex-US labeling ... (outside the US) preferred Travel - Ability to travel up to 10%Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation,… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and ... for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and Intelligence.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel Ability to travel ... up to 20%. In-house office position that may require occasional travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary The Hematology US Scientific Director, Medical Affairs (SDMA) is a regionally based position in our Company's Research Laboratories, US ... Medical Affairs . The role drives scientific excellence and optimizes field...priorities. Along with the USMA Field Leaders (Executive Director (ED)/ Associate Vice President (AV)), the SDMA is responsible for… more
- Merck & Co. (Rahway, NJ)
- …Executive Director, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and execution of scientific ... & medical affairs plans for Ophthalmology). They build and lead a...team of TA dedicated global and regional directors and associate directors. The Executive Director, Value & Implementation (referred… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director, Global Oncology Communications , will support the creation and implementation of external communications strategies, plans and ... pipeline, in partnership with key stakeholders and our Corporate Affairs and Enterprise strategy.Lead and support late-stage oncology pipeline communications… more
- Merck & Co. (North Wales, PA)
- …(Hybrid work model is combination of in-office and work from home) The Associate Director Market Access will work closely with agency partners, internal brand ... This role will report to the Director, Oncology Market Access. The Associate Director Market Access will be responsible for supporting Brand products tactical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director, Research Partnerships (RP) is responsible for developing and executing Real-World ... research objectives, in alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead for research within a specific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director, HCP Experience has overall strategic and operational responsibility as well ... brands. Relationships Reports to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding TA and with… more
- Insmed Incorporated (New York, NY)
- …adequate training, access to educational resources and alignment between Insmed's medical affairs plans and the unmet needs of the patients and healthcare ... development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. This may include trial site identification, ongoing recruitment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director, Regional Marketing Conventions & Field Programs is responsible for managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and Operational… more
- Merck & Co. (North Wales, PA)
- …health authority regulated environment - Understanding of pharmacovigilance, medical affairs , clinical operations and product quality complaints processes and ... systems Working Knowledge of Veeva technology productsUnderstanding of regulatory requirements that drive IT delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory… more
- Merck & Co. (North Wales, PA)
- …necessary agreement terminations.Work closely with Finance, Investor Relations, Public Affairs and partners to manage appropriate financial obligations / disclosures ... material to our Company and/or its partners.Provide input and contribute to the development of future external partnerships including company evaluation, governance structure and partnership launch preparationBecome our internal expert on the partner company… more
- Merck & Co. (Rahway, NJ)
- …in the execution of clinical studies.--Will report and work collaboratively with the- Associate Vice President to promote the development strategy of the company on ... cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …planning and execution to assigned Novo Nordisk, Inc. therapeutic areas. Assist Associate Director with development and execution of annual strategic convention plan ... Relationships Reports to the Manager, Convention Marketing reports to the Associate Director, Convention Marketing of the Strategic Meeting & Event Management… more
- Merck & Co. (Rahway, NJ)
- …closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... assist the Associate Vice-President/Vice-President and product development team lead in ensuring that appropriate corporate personnel is informed of the progress of… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the Manager of ... Regulatory Affairs to create and collate product master files (dossiers),...13485:2003, COSMOS/ECOCERT, etc). + Assist the Manager of Regulatory Affairs for facility registrations, renewals, and document submissions to… more
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