- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide… more
- Merck & Co. (Rahway, NJ)
- …applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems ... Job DescriptionThe Associate Director , ESQL is responsible for...EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the… more
- Merck & Co. (Rahway, NJ)
- …Language (include Requirements For Education, Experience And Skills)Job Description:The Associate Director Quality Assurance, Facilities, Validation & Automation ... West Point, PA site).- The role is reports to the Director of Facilities and Validation.Primary ResponsibilitiesResponsible for providing quality assurance support… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop and maintain SDLC documentation.Actively work in a multi-discipline… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior ... Director , Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver omnichannel and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... operations at Insmed's CMOs including tech transfer, process optimization, clinical/ commercial manufacturing, process characterization and validation, and manufacturing CMC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of (mAb, Drug Substance, Drug Product, or New Modality) for investigational and commercial drugs to the sites of manufacture, both internal and external to Daiichi ... Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory … 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... related to plant maintenance and spare parts procurement systems.Working knowledge of regulatory requirements in accordance with GMPs.Ability to work in a highly… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... commercial insights and analytics, Privacy, Legal, Compliance, marketing, Market...support programs data strategy aligns with organizational goals and regulatory requirements, working closely with key stakeholders to drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality. Regularly interfaces with multiple NN ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Quality departments. Additional regular stakeholders include NNI Commercial business unit. Drives and maintains positive rapport and… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... promotion of prescription drugs, biologics, and devices. **ESSENTIAL FUNCTIONS** + Provide regulatory leadership and guidance to Commercial teams during the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … commercial activities to US regulatory agencies. You will manage the commercial regulatory strategy and execution of such for one or more high-volume ... work of one or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional Review Committee (PRC) meetings… more
- Sanofi Group (Bridgewater, NJ)
- …internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects + Liaises ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...with clinical, commercial , and other internal business partners in partnership with… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …for this position. Additionally this job cannot be based in Basking Ridge, NJ._ The Associate Director will be a member of Regeneron's New Products Commercial ... expansive pipeline portfolio and play a key role in driving the global commercial strategy across all stages of development. This will be an exciting opportunity… more
- embecta (Parsippany, NJ)
- …our social channels on LinkedIn , Facebook , Instagram and Twitter . As the Associate Director of Customer and Commercial Operations at embecta, you will ... steward of fees, rebates, chargebacks, and customer master data within our commercial operations. Your role will be pivotal in ensuring accuracy, efficiency, and… more
