- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical ... Regulatory Affairs Operations with Labeling Process and/or Digital Enablement...soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS… more
- 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)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … 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
- Revolution Medicines (Redwood City, CA)
- …with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Associate Director of Regulatory Affairs will independently represent ... teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes. Demonstrate leadership within the regulatory affairs… more
- Genmab A/S (Princeton, NJ)
- …a fit? Then we would love to have you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... of our Global Regulatory Affairs organization. In this role, you will work...you will work in close collaboration with the Global Regulatory Lead on a compound in late-stage development to… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/ Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a ... cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with… more
- Merck & Co. (San Francisco, CA)
- …component of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an... Associate Director will work with scientists within… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and ... in alignment with overall business objectives. Relationships Reports to the Sr. Director , Wegovy Consumer Marketing . C ollaborates with sales, marketing, training,… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The RoleThe 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
- 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 ... Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing ... priorities and effectively delegate and assign activities to meet the business needsAbility to develop short and mid-range project plans that are realistic and effective at meeting goals.Strong analytical skills to drive operational milestones Influence… 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 ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… 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
