- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. SummaryThis position 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 (GRLs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …license renewals, responses to Health Authority)- Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in ... collaboration with the CDL- Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of the Investigator's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a ... Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard ... problems of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at Novo Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have a reporting relationship ... validity and medical accuracy, as well as consistency with the FDA-approved labeling . Assist the Promotional Review Board (PRB) team to ensure all promotional… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …candidate will assist in administrative functions of study execution such as labeling collection tubes and transporting supplies to appropriate area, quality control ... work assignments and acting as primary point of contact for the study director for a particular shift.QualificationsRequires a high school diploma or equivalent and… more
- Ascendis Pharma A/S (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labelling will be responsible for labelling activities across programs and stages of development, with specific ... and the Americas and supporting global needs as required.The RA Associate Director , Labelling will be overall responsible for ensuring compliance with US regulatory… more
- TransPerfect (San Francisco, CA)
- Director of Business DevelopmentLocations: US-San Francisco, CA; US-Seattle, WA; US-RTP, NC; US-Los Angeles, CA (5700 Wilshire); US-New York, NY (1250 Broadway)Time ... each also has its own unique rewards.TransPerfect's DataForce division is hiring a Director of Business Development to focus on all phases of business development… more
- Mannkind Corporation (Boston, MA)
- Position: Executive Director /Vice President, Head of Regulatory Affairs Location: Boston, MA Job Id: 11071 # of Openings: 1 At MannKind our employees are our number ... better. Position Summary: MannKind Corporation is currently seeking an Executive Director /Vice President, Head of Regulatory Affairs. Reporting to MannKind's Chief… more
- Travere Therapeutics (Boston, MA)
- …of elevating science and service for rare patients.Position Summary:The Executive Director , Regulatory Affairs will develop and execute global regulatory strategic ... are maintained.Ensure compliance with product post marketing approval requirements.Ensure labeling , publications, advertising and promotional items are compliant with… more
- MannKind Corp (Boston, MA)
- …the better.Position Summary:MannKind Corporation is currently seeking an Executive Director /Vice President, Head of Regulatory Affairs. Reporting to MannKind's Chief ... with Commercial, Legal, and Clinical for development and review of labeling , advertising, and promotional materials.Lead, develop, mentor, and manage the Regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Regulatory Affairs Advertising and Promotion Locations: United States - California - Foster City Time Type: Full time Posted On: Vor 11 Tagen Job ... operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. Example Responsibilities: Provides commercial regulatory… more
- IGM Biosciences, Inc. (Mountain View, CA)
- …inflammation targets. For more information, please visit www.igmbio.com.Position SummaryAs Director , Clinical Supply Planning and Project Management, you will lead ... plan for all internal and external drug substance, drug product, packaging, and labeling operations. You will also develop and drive the Long-Range Operating Plan… more
- Avidity Biosciences (San Diego, CA)
- Job Title: Associate Director - Regulatory AffairsLocation: San Diego, CA / Hybrid / RemotePosition type: Full timeFLSA: ExemptDepartment: Regulatory AffairsStrive ... and engage with us on LinkedIn and Twitter.The OpportunityThe Associate Director , Regulatory Affairs is responsible for establishing regulatory strategies in… more
- Roblox (San Mateo, CA)
- …scale, and helping to create safer, more civil shared experiences for everyone. Director of Product, Safety PlatformRoblox's vision is to connect billions of people ... continuously evolving as our community grows.About the Role:As the Director of Product for Safety, you will oversee a...moderationBuild custom tooling for moderation, customer support, and ML labeling that will be used by Roblox staff and… more
- Shockwave Medical (Santa Clara, CA)
- …of sonic pressure waves for the treatment of calcified plaque.Position OverviewThe Sr. Director , Office of Medical Affairs (OMA) is responsible for the oversight of ... Job FunctionsAs a scientific resource and people leader, the Sr. Director , OMA responsibilities include:Objectives and deliverables of direct reports including… more
- Helen of Troy (Boston, MA)
- Join our Beauty and Wellness Team at Helen of Troy as our Director of Product Manager, Liquids (hybrid work onsite and from home), and make an immediate impact on ... Location:Boston, MAWhat you will be doing:We are looking for a savvy, passionate Director of Product Development who is excited about launching new products in the… more
