- Novo Nordisk Inc. (Plainsboro, NJ)
- …and always seeks to improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline ... education and collecting data to support efficacy and new product development , CMR is involved. The one...needed. Relationships This position reports directly to the Executive Director , Clinical Development Strategy (CDS)… more
- 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
- 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
- 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)
- …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
- 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)
- …cholesterol lowering through robust omni-channel approaches. -Act as strategic counselor on strategy and issues management, in coordination with Director , peers ... Job DescriptionThe Associate Director , Global Cardiometabolic Communications will be part of...and will collaborate closely with cross-functional teams on the development and activation of integrated, comprehensive communications strategies and… 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
- 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
- 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
- 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
- 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. (Rahway, NJ)
- …position will require: Outstanding leadership in market assessment, product clinical development , product strategy , market development , thought ... /asset development teams, Key Opinion Leader engagement execution, competitive strategy , target product profile development , health authority… more
- Merck & Co. (NC)
- Job DescriptionRole SummaryThe Cardiovascular & Metabolism Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease ... Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non- product areas of interest to the Company and replies to scientific… more
- Merck & Co. (North Wales, PA)
- …FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the product development and labeling ... business objectives and minimize regulatory risk-Provide regulatory consultation in the development and implementation of US marketing strategy and promotional… more
- Merck & Co. (Rahway, NJ)
- …teams and subject matter experts to establish and implement the scientific strategy for process development and technology innovation. Working collaboratively to ... Job Description Director - Fermentation Operation (P5) The Continuous &...a related field. Extensive academic or industrial experience in product , process, or technology development : o BS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP) Development of clinical sections of trial-level regulatory documents… more
- Merck & Co. (Rahway, NJ)
- …insights.- She/he will act as a core point of contact regarding development of product and indication forecasts and forecast-related insights.The ideal ... Job DescriptionAssociate Director , Strategic ForecastingThe Associate Director , Strategic...these to the business to help action the marketing strategy .- The individual in this role will work extremely… more
- Merck & Co. (Rahway, NJ)
- …launches.Principal ResponsibilitiesLead and set direction for the device development strategy for multiple drug-device combination product development ... analysis.Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy ,… 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
