- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...regulatory agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more… more
- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs ... encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Engagement team, enabling and governing the medical affairs omnichannel engagement strategy . The Associate Director - MOE will work with one another and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely… 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
- 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)
- …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)
- …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
- 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...scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy … 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy ... leaders to define DS's unified position and external engagement strategy on key topics. This role will also define...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Eisai, Inc (Nutley, NJ)
- …from you.The Sr Medical Director provides medical leadership for medical affairs strategy , planning and supportive tactics mainly for GU therapeutic area. ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… 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)
- …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)
- … 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)
- …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
- Merck & Co. (North Wales, PA)
- …within Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, ... regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development (R&D), Quality ... Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with… more
