- Tris Pharma (Monmouth Junction, NJ)
- …clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development , Research and Development (R&D), Quality ... in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development . Title and salary commensurate with… more
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We ... success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …program. The Director will provide high level strategic input into development plans, study designs, and regulatory submissions. The Director will provide ... About the Department Our East Coast Global Development Hub brings together the best minds in...Are you ready to make a difference?The Position The Director , Medical Writing is an expert in medical writing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... for a living. Are you ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support the Director of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... of timely and up to date scientific information relevant to ensure personal development of the team; and between the field-based Medical Liaison team and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... date with the latest methodologies and insights. Relationships Reports to the SR Director Sales Reporting & GtN. Internal relationships include Senior HQ & local… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety actions, and communication and risk minimization plans.Authors or oversees the development of minimum core product safety requirements for inclusion in ... protocols (CSPs) and Informed Consent Forms (ICFs), for assigned product (s)Authors or oversees the development of the...(ICFs), for assigned product (s)Authors or oversees the development of the Safety Management Plan for assigned … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... Responsible for the development and execution of data strategies for patient support...optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo...processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... role is based in Plainsboro, NJ. The Position The Director Market Access Trade Strategy is part of a...well as vendors and consultants. Essential Functions Leads on development of overarching strategy for Trade channel, ensuring cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and execute ... oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will...manager oversight, the individual will lead global pricing strategy development , access strategy development and partner with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Teams including strategic development and execution of an integrated product development plan. This position may independently manage a lower ... of the clinical development plan in alignment with the product development strategy.Manages team meetings including developing agendas and documenting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global pharma innovator in oncology, a therapeutic area known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and ... as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization ... consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety...may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development , integration, and execution ... is provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and PR. This… more
