- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Genmab (NJ)
- …and feel 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 ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Eisai, Inc (Exton, PA)
- …coaches, and develops staff to maximize individual potential and to grow and retain scientific talent.The Associate Director is primarily responsible for the ... Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… more
- Merck & Co. (Rahway, NJ)
- …in West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - ... As an Associate Director , you will represent QP2 on...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Genmab (NJ)
- …to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Merck & Co. (Rahway, NJ)
- …facility in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and ... candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational...to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...Affairs, APAC (Asia Pacific) is to combine knowledge of scientific , regulatory and business issues to enable… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design 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 ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Merck & Co. (Rahway, NJ)
- …a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Kyowa Kirin North America (Princeton, NJ)
- …with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion ... with US regulatory requirements. In addition, the associate director will be responsible for supporting...PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …market that are making a real impact on patient outcomes. Job Summary: The Associate Director of Post-Marketing is responsible for providing management of a ... ex-US sales and promotion and labeling of commercial products May attend scientific sessions for regulatory affairs department. Other duties as assigned… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... Ethics & Integrity. - Required Experience and Skills:- - Bachelor's degree in a scientific , business, or related discipline required , MS/MBA preferred . - At least… more
- Merck & Co. (North Wales, PA)
- …and performance managementCore SkillsDemonstrated ability to drive and manage scientific activities on clinicalprotocols. This position may represent the company ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
