- Parexel (Annapolis, MD)
- …for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional ... on impactful global programs that directly support patient safety and regulatory compliance . - Collaborate with a diverse, international team across multiple… more
- GRAIL (Annapolis, MD)
- …labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on international ... with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material… more
- Parexel (Annapolis, MD)
- We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major client ... that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product … more
- Parexel (Annapolis, MD)
- …members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance . **About the Role** As a **Senior Physician in ... drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure… more
- Terumo Medical Corporation (Elkton, MD)
- …in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements. o Demonstrated understanding of ... and design. Responsible for contributing to the DHF and regulatory submittals, creating SOPs, and for providing training to...Develop and execute projects in accordance with Terumo new product development process in full compliance with… more
- Parexel (Annapolis, MD)
- …and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key ... the quality of investigator sites (eg patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction,… more
- Parexel (Annapolis, MD)
- …and payment issues etc.) + Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the ... + Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for… more
- Organon & Co. (Annapolis, MD)
- …together and Keep moving. + Ensures proper diligence on policy, legal, regulatory , and company compliance issues. **Required Education, Experience and Skills** ... customer; negotiation and execution of pharmacy discount agreements and product contract offerings; individual account performance against strategic, financial and… more
- Terumo Medical Corporation (Elkton, MD)
- …awareness, training and knowledge of Terumo Safety Policies and Procedures to assure compliance with regulatory , global and site quality requirements. 3. ... SAP/MHCS systems. 6. Responsible for additive preparation function, including preparing product coatings and chemical analysis testing for direct production support… more
- Organon & Co. (Annapolis, MD)
- …and consistent sales performance that exceeds forecast and expectations relating to product goals and drive accountability for all results throughout the district. ... with a high degree of integrity strictly following all our company's compliance policies and procedures governing the promotion of pharmaceutical products in the… more
