- AstraZeneca (Boston, MA)
- …everyone at AstraZeneca can grow and thrive. The Executive Director , Regulatory Science & Strategy provides global strategic regulatory expertise and ... identified by the business and patients. Define and drive disease area global regulatory priorities and play an essential role in shaping Astra Zeneca's approach… more
- Merck & Co. (Boston, MA)
- …execution, monitoring, analysis, regulatory filing, and publication.Specifically, the Executive Director may be responsible for:Evaluating pre-clinical and ... external research project teams relevant to the development of new compoundsThe Executive Director may:Oversee the Clinical Directors and supervise the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior ... Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Merck & Co. (North Wales, PA)
- …regulatory strategies and approaches across geographies.Under direction of the Executive Director , Companion Diagnostics/In Vitro Diagnostics, the Principal ... submissions, as appropriate, and corresponding therapeutic dossiers.Interacting with global regulatory authorities and diagnostic partners to determine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for managing the multiple Clinical ... Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...collaborates with the key stakeholders and leaders across the Global Daiichi Sankyo R&D organization to achieve desired business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …partner with cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is ... for the recruiting, appraisal and development of personnel under their supervision.The Executive Director selects, trains, and effectively works with colleagues… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Operations, Collate and produce accurate and timely reports as needed pertaining to Global QA activities- In collaboration with Executive admin, ensure QA org ... to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA… more
- Merck & Co. (Rahway, NJ)
- …authorization concepts, and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and ... drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …CMR, Global , Field Sales, Account Management, Analytics, Investor Relations, Regulatory , and all others, including global colleagues/counterparts, on a ... routine basis. Interacts with NNI Executive Team as well as senior...Global , Field Sales, Account Management, Analytics, Investor Relations, Regulatory , and all others on a routine basis Liaises… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the… more
- Merck & Co. (Washington, DC)
- …analyses to produce reports on global policy environment as requested by Executive Director , AVP, other GPP LT members.Contribute to quarterly and annual ... Strategic Planning & External Engagement team, reporting to the Executive Director , Policy Development & Strategy.The Associate...to ensure that they are fit for purpose for global , regional, and country policy planning and activity tracking.… more
- Merck & Co. (South San Francisco, CA)
- …health systems accountsServes as a resource for the HSO MAD Team Lead, HSO Executive Director Medical Affairs, and other members of Country Medical Affairs on ... Job DescriptionHealth Systems Oncology Medical Affairs Director , US Medical Affairs - NorCal, NV, AZThe...in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also… more
- Merck & Co. (Rahway, NJ)
- …translation in bioperformance of formulationsThe Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop… more
- Merck & Co. (North Wales, PA)
- …Pulmonary Arterial Hypertension (PAH)/Rare Disease Business Unit is recruiting an Associate Director of Healthcare Consumer (HCC) Marketing for PAH in the United ... States.- The Associate Director of HCC Marketing will lead key elements of...rare disease therapy commercialization, -and an understanding of US regulatory environment. Location: This position is location agnostic.-For remote… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …in cellular immunotherapy, this role is for you. This individual will report to the Executive Director in R&D. This position will play a pivotal role in shaping ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development… more
- Merck & Co. (North Wales, PA)
- …will have managerial responsibilities of ADT Leaders or Team Members that could include Executive Director , Senior Director , or Director level personnel ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
