- 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is ... a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team of engineers and technical… more
- Merck & Co. (Durham, NC)
- …to ensure a successful Validation support of the vaccine manufacturing facilities.The Associate Director , Validation will be responsible for providing Validation ... team within the Technical Operations organization.Position Responsibilities: Reporting to the Director , Validation the incumbent will lead the team of validation… more
- Merck & Co. (Rahway, NJ)
- …Overview - Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead ... every aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with...participating in supplier audits, and addressing any quality and regulatory issues.- This role aims to ensure compliance with… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director … more
- Genmab (NJ)
- …readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight ... feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within… more
- Merck & Co. (Durham, NC)
- Job Description Position Description: The Associate Director , HVAC & Utilities Engineer is a member of the Plant Engineering team providing technical support to ... systems regarding functionally of equipment and relied on as SME during regulatory discussions for HVAC/R. PROBLEM SOLVING: Identifies and resolves technical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strong collaborators, as we embark on shaping our future. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Reports to the Rare Bleeding Disorders TA lead (A/B). Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding Disorders TA and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Excellence will guide launch planning and execution at NNI ... to business growth and success. Relationships Reports to Executive Director Launch Excellence. Collaborates with cross-functional teams, including, brand marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role in managing the ... to business growth and success. Relationships Reports to Executive Director Launch Excellence. Collaborates with cross-functional teams, including brand marketing,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , Strategic Collaboration role is responsible for fostering partnerships ... the rare disease landscape, including knowledge of key stakeholders, regulatory requirements, and emerging trends Exceptional negotiation, communication, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure strategic coordination across Novo Nordisk. Partners closely with Associate Director - Enterprise Strategy Activation. External relationships may ... plans to drive growth and longer-term value. Close collaboration with the Director of Enterprise Strategy Activation is essential to ensure strategic shifts and… more
- Legend Biotech USA, Inc. (Chicago, IL)
- Legend Biotech is seeking a Regional Key Customer Marketing (Central) Associate Director as part of the Commercial team based in (but not limited to) AZ, IL, or ... are always within label, and consistent with commercial, compliance, legal and regulatory guidelines.The KCM will work closely, and within approved SOPs, with other… more
- Merck & Co. (North Wales, PA)
- …medicines that help people around the globe. We are currently recruiting for Associate Director , US MarketingThe role will oversee foundational strategy and ... drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc.Our US marketing team has adopted an Agile operating model… more
- Merck & Co. (Rahway, NJ)
- …concepts, practices, principles and sampling techniques and instrumentationIH regulatory requirements, industry consensus standards, and recognized best practicesAir ... Employee Training, Environmental Health and Safety (EHS) Management, Environmental Regulatory Compliance, General Safety, Health Safety, Health Safety Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response… more
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