- Taiho Oncology (Princeton, NJ)
- …internal stakeholders on mapping out the primary publication plan for scientific and clinical studies in process, prior to regulatory submissions, and assessment ... understand and deliver critical capabilities of medical affairs organization: clinical research , evidence generation, value demonstration, medical communication,… more
- Merck (Trenton, NJ)
- …Provide final regulatory review and approval of: + Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local ... in IBD strongly preferred. **Primary Responsibilities** + Develop and lead global regulatory strategies to support multiple indications, optimizing...registration study protocols for secondary markets + Represent Global Regulatory… more
- J&J Family of Companies (Raritan, NJ)
- …TA/Product GMA Budget and vendors. + Lead all aspects of the Research Concept Approval Process for Medical Affairs studies . Ensure consistent implementation ... pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with...Medical Affairs Owned Cross-Pharma Policies and SOPs, such as Research Concept Approval Process and System, Publication SOP and… more
- Cardinal Health (Trenton, NJ)
- …leaders including key opinion leaders (KOLs) to communicate and understand key relevant clinical and research insights and develop and deploy scientific and ... and within a region to maximize theranostic knowledge and clinical strategies + Lead scientific strategy at...research of NPHS products + Collaborate with NPHS Clinical Affairs to enhance patient enrollment in NPHS-sponsored … more
- Bayer (NJ)
- …brand strategy; including facilitating investigator-initiated research (IIR) and research site identification; + Responsible for supporting clinical trial ... and/or Medical Affairs experience in multiple therapeutic areas; + Coordinates and lead TA updates, team discussions, training initiatives (ie journal clubs); +… more
- AbbVie (Florham Park, NJ)
- …projects. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols ... NJ The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific… more
- System One (Raritan, NJ)
- …Manage the TA/Product GMA Budget and vendors. + Manage and supervise the Research Concept Approval Process for Medical Affairs studies . Ensure consistent ... partner with the GMALs in one or more designated. Therapeutic Areas/Products to lead the operational aspects of the Global Medical Affairs Function, including: *… more
- Merck (Rahway, NJ)
- …or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding ... DSCS Digital Implementation Project Manager** Within the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline… more
- Sumitomo Pharma (Trenton, NJ)
- …strategy and oversight for the development of a supportive US Investigator Initiated Study and Collaborative Research program. + Provide detailed and compliant ... diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients sooner. For more… more
- Organon & Co. (Jersey City, NJ)
- …global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for programs in ... clinical development, marketing applications and post-approval life cycle maintenance...limited to: **Responsibilities** + Serve as the CMC Product Lead or support the CMC Product Lead … more