- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan ... or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... into a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader… more
- Eisai, Inc (NJ)
- …Director , US Medical Affairs provides medical leadership for medical affairs strategy , planning and supportive tactics for assigned therapeutic area. This ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level, while also seeking their input and feedback to inform state government affairs strategy and engagement. Contributes to internal and external advocacy and ... diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...support representatives in answering physicians questions Works with Executive Director to define therapeutic area disease and treatment concepts… more
- Eisai, Inc (Nutley, NJ)
- …Summary The Medical Director will provide medical leadership for medical affairs strategy , planning and supportive tactics for assigned therapeutic area. ... Under the direction of the Senior Medical Director , this role will be responsible for working with...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing, Branded Strategy & Execution will be a ... brand's HCP Agency of Record.Work closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly… more
- Merck & Co. (Rahway, NJ)
- …multiple internal stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as external partners (diagnostic ... across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... and evidence generation for a successful market access strategy across Daiichi-Sankyo. He/She will drive the asset specific HEOR strategy and coordinate all… more
- Insmed Incorporated (Bridgewater, NJ)
- …compliance guidelines/policies, and budgetsEnsure deliverables are in alignment with business strategy , medical affairs strategy and Insmed clinical ... and leads the development and implementation of global Medical Communications Strategy across regions. The Director will develop collaborative partnerships… 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...Has a strategic portfolio mindset. Is able to influence strategy and translate strategy into daily operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and inspection preparedness for the respective PV inspections in alignment with regulatory and company strategy .Act as the management representative for all ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the... in close alignment with the CSPV and Medical Affairs business strategy .Monitor and track implementation and… 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. ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...Triple Bottom Line in Market Research, analytics and internal strategy consulting Lead the development of innovative solutions to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by related internal groups (eg patient advocacy, ID Office, field medical, regulatory affairs , etc.)-Establish and oversee indication or study specific ... establishment and oversight of an Inclusive Research and Patient Voice Strategy and Infrastructure, 2) Identify innovative approaches, industry best practices,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical ... significant experience in scientific/ regulatory fields required- Experience in international Regulatory Affairs - CMC preferred Daiichi Sankyo, Inc. is an… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at meetings with health authorities; Leads the creation of developmental and regulatory strategy ; Accountable for performance of CROs; Routine interactions with ... in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions- Study… more
- Tris Pharma (Monmouth Junction, NJ)
- …the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior Medical Director ... development/delivery and execution oversight of the Pain clinical development strategy and clinical development plans. Reporting to the Vice President/Clinical… more
