- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and ... the most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing ... scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documentation for submission. Prioritizes workload as necessary.Keeps current with latest Health Authority guidelines and provides Regulatory advice to members ... by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and… more
- Merck & Co. (North Wales, PA)
- …five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … submissions in OncologyManagerial experience preferredExperience with global submissions and regulatory health authorities Travel - Ability to travel up ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical… more
- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be responsible for: Providing scientific and medical ... on scientific questions relevant to his/her areas of responsibility. The Director is responsible for maintaining a strong scientific fund of knowledge… more
- Merck & Co. (Rahway, NJ)
- …on scientific questions relevant to one's areas of responsibility.The Clinical Director is responsible for maintaining a strong scientific fund of knowledge ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving… more
- Merck & Co. (Upper Gwynedd, PA)
- …peer-to-peer interactions, research and educational collaborations, interactions with global scientific societies and health organizations, publications, or ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline...relevant internal stakeholders - early development teams, commercial, CORE, Scientific affairs, Market Access, among others - to develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Merck & Co. (Rahway, NJ)
- …disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.Our ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …scientist on the clinical trial team.Collaborates with the Medical Writer on clinical/ scientific and regulatory documents.Partners with Study Manager on study ... Job DescriptionJob SummaryThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …staff in the creation of the development strategy ensuring the highest scientific /medical standards in accordance with ethical and regulatory requirements across ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision. Health Authority Interactions: ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Director to support our rapidly expanding cardiology respiratory, metabolism and ophthalmology ... pipeline.As a Director , you will serve as an expert QP2 representative...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
