- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director, Global Oncology Medical Affairs , Medical Analytics will be ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function… more
- Merck & Co. (Montgomery County, PA)
- …in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... Scientific and Patient Support. This is an exciting time...collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... kanri / scorecard) and drive execution using MPS/Lean principles and scientific problem solving.Provide subject matter expertise for product release, aseptic… more
- Merck & Co. (Boston, MA)
- …as immunology, neurology, cardiometabolic and others as needed by the pipeline.Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... Job DescriptionThe Associate Vice President (AVP) / Companion Diagnostics will...an essential strategic and tactical role in overseeing the scientific direction of companion diagnostics (CDx). - Specifically, the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …assessing their clinical viability, market potential, probability of clinical and regulatory success etc.Provide expert recommendations based on scientific and ... target product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... on this goal. Our R&D Laboratories are a true scientific research facility of tomorrow and will take our...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory / Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA)...the overall strategic plan + Work cross-functionally and provide regulatory , scientific and quality expertise and support… more
- Nestle (Arlington, VA)
- …the business environment and basic market consumer trends within the context of Regulatory and Scientific Affairs . + Collaborate with cross-functional ... EXPERIENCE: 1-2+ years experience in the food industry, primarily in regulatory affairs , regulatory compliance, food labeling, nutrition, or product… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Hematology. As a subject matter expert on scientific ... of scientific communications strategy and deliverables, the ** Associate Director, Scientific Communications Lead, Hematology** proactively defines… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Specific Education & Experience Requirements: + 10+ years of experience in Regulatory Affairs or other relevant industry experience. + Degree in a ... submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible ... appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you will contribute:**… more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs ** , works out of ... reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and...preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. +… more
- GRAIL (Menlo Park, CA)
- …diagnostics or biomarker development, particularly in oncology, is a plus. + Advanced scientific degree preferred. + Regulatory Affairs Certification (RAC) ... products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible ... your assigned programs. By joining our growing and dynamic regulatory affairs team, you'll be responsible for...core values are: + We are committed to advancing scientific understanding to improve patients' lives + We are… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …together we can continue making a positive impact in the cancer field. The Associate Director, Regulatory Affairs , Advertising and Promotion is responsible ... one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies... Director will report to a Senior Director in Regulatory Affairs , Advertising and Promotion. **This position… more
- Bristol Myers Squibb (Princeton, NJ)
- …The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory ... applicable FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams,… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Associate Principal, Regulatory Affairs **Job Description:** Responsible for establishing and preparing strategy for worldwide product ... skills. 5. Ability to comprehend technical documents and concepts. **External-Facing Title:** Associate Principal, Regulatory Affairs **Posting Country:** US… more
