- General Motors (Trenton, NJ)
- …three times a week, at minimum. **The Role:** The Employee Relations Investigator will perform investigations of misconduct, and/or violations of policy. The ... Investigator will work closely with the HR Policy and...5 years of professional experience in Human Resources, or Corporate Global Investigations + Perform investigations of alleged misconduct… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …accountability for operational study level time, cost and quality deliverables. + Lead the development of the clinical study plan including critical path activities ... for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. + Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under… more
- Merck (Trenton, NJ)
- …(ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and work cross-functionally with the Global Medical ... and increase participation in studies of Our Company compounds by increasing investigator awareness of research opportunities supported by Our Company + Support Our… more
- Ascendis Pharma (Princeton, NJ)
- …focus/expertise in these areas is a major advantage. The candidate is expected to lead key strategic, cross-as well functional projects as part of the US Medical ... phase IV clinical programs including, patient registries, and oversight of investigator -initiated Studies (IISs) as well as Special access programs. The candidate… more
- J&J Family of Companies (Raritan, NJ)
- …and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + Acts as ... EGS / EDS + Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision + Plan for… more
- Taiho Oncology (Princeton, NJ)
- …and commercial plans. Requires a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, scientific standards ... and meaningful differentiation for medical practice adoption. Performance Objectives: Lead the development of the Integrated Medical Affairs Plan (iMAP) and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Scientist Lead and PSL to author safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing Information, Company Core Data Sheet ... for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Scientist Lead and PSL to author safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing Information, Company Core Data Sheet ... for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical Safety Physician(s), and ... + Independently leads activities without supervision for assigned clinical studies. + Lead activities under the direction of Clinical Safety Scientist Product … more
- Sumitomo Pharma (Trenton, NJ)
- …launch activities related to Medical Affairs function. This individual will lead program coordination with Clinical Development leadership to ensure alignment ... motivation, and control of activities in alignment with the company's corporate strategies and objectives. + Ensure cross-functional medical alignment with the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in a perpetual state of compliance as follows: + Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery ... meetings or other relevant activities. + Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing Quality Oversight… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with the New Product or Commercial Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate ... Experts in Oncology including advisory boards, Congress activities, and investigator initiated studies, advocacy and sponsorships. Interact with investigators and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …May review tables, listings, and figures (TLF) and CSR safety narratives + May lead the development and updates of the Investigator 's Brochure (IB): author the ... **Clinical Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Bristol Myers Squibb (Princeton, NJ)
- …The ideal candidate will have an outstanding level of desire to lead people with a strong leadership track record of creating/leading/transforming teams. He/she ... patients and an immense sense of urgency for strategy and execution. + Lead the cross functional team providing Medical support to the Cardiovascular Mavacamten… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** Gilead's Corporate Legal Group is seeking an attorney who thrives in a high-volume, ... fast-paced, high-performing and collaborative corporate environment. This individual will work within Gilead's Clinical...US and will report to the Clinical Legal team lead . This role will be based on-site in Gilead's… more
- Taiho Oncology (Princeton, NJ)
- …on current focused therapeutic area issues and questions + Set up and lead advisory boards + Review investigator -sponsored study (IIST) proposals and other ... understanding of all areas and functions within medical affairs and able to lead strategic development of the integrated Medical Affairs Plan (iMAP). Having the… more
- Bayer (Whippany, NJ)
- …and/or Medical Affairs experience in multiple therapeutic areas; + Coordinates and lead TA updates, team discussions, training initiatives (ie journal clubs); + ... projects aligned with medical and brand strategy; including facilitating investigator -initiated research (IIR) and research site identification; + Responsible for… more
- Sumitomo Pharma (Trenton, NJ)
- …internal company programs and external facing interactions. This job will effectively lead and communicate with cross-functional team members to develop and execute ... communication, education and awareness stakeholders. + Serve as a Medical Strategy lead for the Pfizer alliance for Prostate, ensuring coordination and alignment of… more
- Bristol Myers Squibb (Princeton, NJ)
- …Area Heads / Directors within Medical Safety Review. Takes the global lead in assuring consistent application of work practices and processes. Delegates to ... input the development of the Reference Safety Information section of the Investigator 's Brochure; provides peer review for safety documents (RMP, IB, aggregate… more