- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required. Travel Ability ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda for and ... Medical Affairs and will assist the Executive Director and Sr . Director (where...Plan (EGP), in collaboration with Senior Medical Director Serve as NNI Medical Affairs representative… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support the organization's long-term aspirations. Relationships Reports directly to the Sr . Director , Planning, Execution & Operations, with a strong dotted ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Tris Pharma (Monmouth Junction, NJ)
- …an experienced MD with expertise in the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. ... The Executive/ Senior Medical Director provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate ... of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development (R&D), Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... will help develop multiple products. In doing so, the Senior Medical Director will work across different...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and...across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director...Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This ... Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the ... creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions...strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical ... regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical...and is also an integral member of the Medical Affairs Team. This position plays a key role in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and Non-clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director - Safety Surveillance, US East Coast ... Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stage) within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other RD functions to ensure effective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... and related materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the… more
- Novo Nordisk (Princeton, NJ)
- …company goals. Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & ... living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic … more
- J&J Family of Companies (Trenton, NJ)
- …of the Johnson & Johnson Family of Companies, is recruiting for a Director / Senior Director , Clinical Rseearch Physician for **Late Development Oncology** ... Medical Director / Sr . Med Director ,...the Compound Development Team (CDTL) and project management, global regulatory affairs , clinical pharmacology, health economics, and… more
- Novo Nordisk (Plainsboro, NJ)
- …Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda for and ... Medical Affairs and will assist the Executive Director and Sr . Director (where...Plan (EGP), in collaboration with Senior Medical Director + Serve as NNI Medical Affairs … more
