- Merck & Co. (North Wales, PA)
- …Scientific Strategy for PAH. The Customer Agile Team consists of the Product Owner, marketers, and development team members.This position will report to the ... the Pulmonary Arterial Hypertension (PAH) brand team leading Scientific Strategy . A robust and informed Scientific Strategy ...PAH HCP CAT Product Owner, Director of Marketing, and will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Oversees and leads pricing and contracting strategy , playbook, and guideline development for all new product launches within responsible therapeutic area, ... your potential? The Position Formulates, leads and executes the pricing and contracting strategy for a key Novo Nordisk product category. Collaborates with… more
- Genmab (Plainsboro, NJ)
- …(s)BLA submissions. Evaluate various regulatory mechanisms that allow optimization of product development (eg, orphan drug designation, breakthrough therapy ... fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to...the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy … more
- Merck & Co. (Rahway, NJ)
- … registration, commercialization and life-cycle management in R&D.Expertise in innovation development across biopharma and other science-based product industries ... global accountability across our Company to drive our Research & Development Division pipeline progression as collaborative leaders through organizational alignment,… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior ... Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will provide medical affairs leadership for...development and execution of the US Medical Affairs strategy that is aligned with the company's goals and… more
- Genmab (Plainsboro, NJ)
- …as BLAs/MAAs. Evaluate various regulatory mechanisms that allow optimization of product development (eg, orphan drug designation, breakthrough therapy ... this role, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the assigned… more
- Genmab (Plainsboro, NJ)
- …our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance ... Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be...advising teams on global labeling strategies based on Genmab's development programs, target product profile, and competitive… more
- Merck & Co. (North Wales, PA)
- …preparing for multiple potential launches of our medicines and vaccines. As the Associate Director of Launch Strategy and Operations, you will play a vital role ... transform the US market as a key player in product launches and launch excellence capabilities within our US... launches and launch excellence capabilities within our US Strategy and Commercial Model Innovation (SCMI) organization! If you… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management, co- development and co-promotion discussions. ... current academic, clinical trial and practice issues related to DS Oncology development and therapeutic strategies.- Partner with the commercial teams to oversee and… more
- Merck & Co. (Rahway, NJ)
- …non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Updates, Quarterly Reports) in paper and electronic format.Participate in global product team meetings ( development and marketed products); provide regulatory ... support and guidance and manage day-to-day regulatory activities.Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.Mentor/instruct and provide guidance to direct… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D)...Development , CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global...consistent with CDP and aligned to achieve the Target Product Profile (TPP) Development of clinical sections of… more
- Merck & Co. (Rahway, NJ)
- …years of experience in project management or a related role required - Product development experience required ; in a pharmaceutical/biotech industry preferred - ... Job Description Job Description: - The drug development Project Manager is part of Global Project...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a ... education and collecting data to support efficacy and new product development , CMR is involved. The one...quantitative method review) Facilitates integration of the US PED strategy into clinical development programs, post-authorization and… more
- Merck & Co. (Rahway, NJ)
- …our cardiovascular pipeline. In this role, the Director will lead the development and execution of global market access strategy , payer value proposition, ... related to price, value and affordability challenges at the appropriate time of product development and launch. -Partner closely with the cross functional team… more
- Insmed Incorporated (San Diego, CA)
- …the research and commercial departments.ResponsibilitiesDesigning and implementing the clinical development strategy and clinical protocols and delivering high ... for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility… more
- Merck & Co. (Rahway, NJ)
- …impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based ... highly desired.Experience in regulatory compliance expectations across all phases of product development to commercializationExperience with in silico, in vitro,… more
- Merck & Co. (Rahway, NJ)
- … and Commercialization Expertise :- Proven experience in small molecule product development , commercialization, and supply, including comprehensive knowledge of ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization...with enterprise goals. Ensure the successful transition of drug product candidates from development to commercialization to… more
- Merck & Co. (North Wales, PA)
- …exchange does not include promotional claims about any drug, vaccine, or biologic product .-- Regional Medical Scientific Director have no sales objectives or ... Job DescriptionRole SummaryThe Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP,...(SLs). The role provides balanced, factual, scientific information about non- product areas of interest to the Company and replies… more
