- 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
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The Associate Director ... all activities are conducted efficiently and in compliance with legal and regulatory requirements. Manage and provide technical guidance to a team of digital… more
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development, will be ... to understand training needs and translate into actionable and enriching associate learning curricula and fostering connections among commercial associates.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director , Business Development Execution, the primary function includes coordinating various ... GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.-… more
- Merck & Co. (Rahway, NJ)
- …(L3 Next) or other strategic frameworksGlobal experienceKnowledge of Company commercial , regulatory , and legal compliance policiesNOTICE FOR INTERNAL ... Coordinate & facilitate upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology dept. (ie-L3, PIE,… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... as well as preparing for, management and follow up of regulatory inspections. Primary Duties: Operational Quality Management: Overseeing the strategic implementation… 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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …through Phase 3 clinical development and line of sight to process validation and commercial launch.- This role reports into the Associate Vice President, Sterile ... scale up from first in human through line of sight to commercial productionOversee and review CMC authoring activities for DP manufacturingEnsure successful 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
- 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
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Associate Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative,… 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
- embecta (Parsippany, NJ)
- …designed to support the varying needs of our diverse and global employees. As the Associate Director of Customer and Commercial Operations at embecta, you ... steward of fees, rebates, chargebacks, and customer master data within our commercial operations. Your role will be pivotal in ensuring accuracy, efficiency, and… more
- Guidehouse (New York, NY)
- …your career opportunities at https://guidehouse.com/careers **What You Will Need:** As an Associate Director + BA/BS degree in Science, Biomedical Engineering, ... all levels, to deliver product planning, pricing, reimbursement, product commercialization, and regulatory and compliance solutions. Do you think you are up for the… more
