- 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
- 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
- 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
- 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...design, protocol development, study execution, reporting and interpretation of data . Maintain a comprehensive understanding of global regulatory… 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 ... commercial process validation and characterization. You'll design experiments, analyze data , and mentor junior staff, ensuring excellence in execution.Enhance… 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
- 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 ... techniques and instrumentation is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data... regulatory guidelines like cGMP and ICH, and data integrity principles such as ALCOA. Strong data… 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
- 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
- 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 ... maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information)...The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be… 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 ... both technical & business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and… 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 ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… 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...close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure… 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 ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… 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)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality… more
