- GRAIL (MD)
- …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 ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Preferred… more
- United Therapeutics (Annapolis, MD)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Bristol Myers Squibb (Bethesda, MD)
- …brings an expertise in regulatory affairs and related policy. The Associate Director , Regulatory Policy is responsible for driving regulatory ... careers.bms.com/working-with-us . **Job Purpose:** This position is focused on regulatory policy to ensure appropriate and effective regulatory...team, the Associate Director Regulatory Policy… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- **Position Summary:** The Associate Director of Global Medical Affairs Omnichannel will be responsible for developing and leading the omnichannel strategy ... for Global Medical Affairs across all therapeutic areas and brands. This strategic...all omnichannel activities adhere to internal medical, legal, and regulatory standards. + Collaborate with Compliance and Legal to… more
- Johns Hopkins University (Baltimore, MD)
- …Immersive Learning is seeking a **_Simulation Operations Manager_** who will report to the Associate Director of the Simulation Education and the Associate ... developing, evaluating, and initiating disciplinary action as needed, in coordination with the Associate Director of Simulation Education and the Associate … more
- Philips (Baltimore, MD)
- ** Associate Director , Field Medical Lead** The Associate Director , Field Medical Lead develops and implements strategic medical plans aligned with ... company policies. + Collaborates with cross-functional teams, including Marketing, Quality, Regulatory , and Clinical Affairs , to drive product advancement,… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …data scientists and data programmers, and external stakeholders including Medical Affairs , Value and Real World Evidence to provide end-to-end statistical expertise ... approve tables, listings and graphs specifications. + Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and… more
- Grifols Shared Services North America, Inc (Frederick, MD)
- …for the therapeutic area(s). + Partners with the Medical Directors, National MSL Sr Director , and North America Medical Affairs Sr Director to develop ... and regions. The primary responsibility of the MSL Field Director is the management, performance, and coaching of a...of field medical plans, strategy, and activities within Medical Affairs , as aligned with goals and objectives. This position… more
- Gilead Sciences, Inc. (Frederick, MD)
- …and complex supply chains. + Certification in auditing (eg, ASQ, IRCA) or regulatory affairs . + Familiarity with digital audit tools and data analytics ... providing mentorship, performance evaluations, and long-term career development. The Director ensures compliance with global regulatory requirements, marketing… more
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