- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... and coaching to team membersContributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory … more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director , Digital Innovation and Omnichannel Engagement will be responsible for the ... of new products and execution of tactics through broad expertise and strategic leadership, championing new approaches to identify and resolve complex and critical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on ... product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...often works with ambiguity and complex problems, focusing on strategic and operational decisions.ResponsibilitiesActs as point of contact for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include: Finance, North America Clinical Development (NACD) Clinical Medical & Regulatory (CMR), Future Business Strategy (FBS), Strategic Operations (SO, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...within functions. Takes ownership to position & deliver upon strategic NACD goals, including those specifically aligned with the… 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
- Merck & Co. (North Wales, PA)
- …with Hybrid work model (combination of in-office and work from home abilities).The- Associate Director , Digital & Omnichannel Innovation for US Oncology-focuses ... pharma gap in order to achieve differentiated business goalsDotted line to OOS&O Director to inform strategic roadmap development of capabilities and provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of ... the Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide … more
- Insmed Incorporated (Bridgewater, NJ)
- …Development organization, works closely with colleagues in other functions, including strategic interactions with multiple Research groups. The role will provide ... scientific and strategic guidance to global project teams and will oversee...in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs, Government Affairs &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of technical ... 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)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- Merck & Co. (North Wales, PA)
- …and performance management Core Skills Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Proven ability to manage competing priorities ... department, division, and company. Roles requires a proactive approach, strategic thinking and leadership driving toward study goals.Demonstrated leadership skills… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming ... ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response… more
- Merck & Co. (Rahway, NJ)
- …The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research and ... pipeline and infrastructure.The FLEx Co-Leads are responsible for providing tactical and strategic level direction to the cross-functional teams working in the set… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary This position is responsible to support strategic leadership of QA initiatives within QA and will have the primary ... meeting agenda and meeting minutes.- Involve and attend the Global RD/PV/MA QA strategic meeting and create the draft of presentation, meeting agenda and meeting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Merck & Co. (Durham, NC)
- …to have the safest and most compliant operation around the network.EMSS has an Associate Director opening for the Teknika maintenance and Engineering team. The ... leader to support the Teknika IPT. Will lead the tactical and strategic equipment reliability improvements, human resources activities while ensuring a safe work… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the ... and other Global Labeling. Under the direction of the Director of Strategic Labeling, establishes labeling policy...labeling needs. Provides labeling input for Risk Management Plans, Regulatory Strategic and Tactical Plan (RSTPs) and… more
