- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... Years Experience in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory submissions in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... 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
- Merck & Co. (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... performance against metric targets.Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical ... edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement ... to the patients who need them.Responsibilities- With the Head of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and… more
- University Medical Center of El Paso (El Paso, TX)
- Job Summary The Administrative Director of Public Affairs plans and directs the operational, budgetary and personnel activities of the Public Affairs ... communications program while ensuring compliance with federal and state regulatory requirements governing public information and confidentiality. Develops services,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Director , Policy Development The Director , Policy Development serves as the leading expert on above-product public policy ... and geo-political changes that will impact our global business.The Director independently and proactively identifies risks and opportunities, conducts analysis… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Advocacy The Associate Director , Policy Advocacy serves as the senior expert in the Global Public ... in support of the company's business objectives. The Associate Director will proactively research and stay abreast of new...with at least 10 years' experience in international government affairs with a preference for candidates with experience in… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate Director , Policy Strategy and Capabilities is ... the Strategic Planning & External Engagement team, reporting to the Executive Director , Policy Development & Strategy.The Associate Director will develop and… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Merck & Co. (Rahway, NJ)
- … may:Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Policy Development and Strategy is a key leadership role in the Global Public Policy Strategic Planning & External Engagement ... above product policy and political issues, working closely with the Executive Director , Global Policy and Multilateral Engagement and therapeutic area and regional… more
