- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... submissionsProvide oversight for preparation and delivery of materials for regulatory agency meetingsPrepare and deliver high- quality presentations for both… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs , Tactical Implementation, you'll have a ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the ...programs and market. Under the guidance of the Associate Director , you will ensure high- quality , timely, and… more
- Insmed Incorporated (NJ)
- …of IT projects within defined scope, budget, and timelineWork closely with Medical Affairs and other support functions (eg Quality Assurance, Compliance, Legal, ... in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of… more
- Beth Israel Lahey Health (Burlington, MA)
- …works under the direction of the Director of Regulatory Affairs , collaborating closely with clinical departments, quality and patient safety teams, and ... projects. Conduct basic observations, audits, and chart reviews under the guidance of Regulatory Affairs Director to identify areas for improvement.… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of ... Job Description **The Position ** Reporting to the Director in Organon Regulatory CMC, the...Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance) and the ability to be creative and… more
- Endo International (St. Louis, MO)
- …Building Effective Teams RELATIONSHIP WITH OTHERS: Reports to the Sr Director , Quality and Regulatory Affairs . Manages group of exempt direct reports. ... work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …development programs. Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads the...or technical discipline preferred. Minimum of 5 years of regulatory affairs experience. Minimum 2-3 years' work… more
- Eisai, Inc (Philadelphia, PA)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads… more
- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs , Regulatory Affairs , or related functions within the pharmaceutical or ... will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed… more
- Merck & Co. (Rahway, NJ)
- …advanced microscopy and chromatography.Collaborate with cross-functional teams, including research, development, quality control, and regulatory affairs , to ... Leadership, Pharmaceutical Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance,… more
- Insmed Incorporated (NJ)
- …and regulatory review.With Medical Excellence, lead training of Medical Affairs teams on new materials and upcoming educational activities.Ensure delivery of ... future of science, we're in. Are you?About the Role:We're looking for a Director , Scientific Communications on the Medical Strategy and Communications team to help… more
- Catalent Pharma Solutions (Kansas City, MO)
- …The Candidate Bachelor's Degree Required (scientific field preferred). Master's Degree in Quality , Regulatory Affairs , Pharmacy, Chemistry or Biology ... Director , Quality Position Summary Catalent, Inc.... Director , Quality Position Summary Catalent, Inc. is a leading...as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit… more
- Insmed Incorporated (NJ)
- …development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality , and ... we're in. Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's possible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Global Commercial, regulatory affairs , other relevant NNI departments. Essential Functions Identify, ... design pull you in? Are you ready to experiment with us? The Position The Director , Key Opinion Leader Strategy & Engagement will lead a team and critically shape… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …with corporate quality objectives Cross-functional Leadership:Collaborate with Regulatory Affairs , Technical Operations, Manufacturing, and Supply Chain ... Job Summary The Associate Director , Global Product Quality - GMP...or PhD preferred). 8+ years of experience in pharmaceutical quality , regulatory affairs , or technical… more
- Insmed Incorporated (San Diego, CA)
- …and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as well as overall ... the future of science, we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. Job Description About the role: The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring the ... auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high- quality standards, this role supports… more
- University of Pennsylvania (Kennett Square, PA)
- …high-energy environment. Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise in animal ... ecosystem of advanced orthopedic surgery and the translational and regulatory sciences. We seek a Study Director ...Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- The Associate Director , Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and tactical ... through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional cross-functional stakeholders… more
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