- Boehringer Ingelheim (Ridgefield, CT)
- …adequate commercialization efforts starting at early development until the end of the product 's life cycle. + The Medical Affairs strategy related to early pipeline ... considered a plus). + For roles in Early Medical Affairs: Track record in product launch activities in the medical function. + Medical and scientific leadership to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …responsibility for the projects assigned, eg definition of Target Product Profiles, Clinical Development Plan, Pediatric Investigational Plan, core Clinical ... Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data...medical input to the Company Core Data sheet, Annual Safety Report / IND Safety Reports, preparation… more
- Amgen (Washington, DC)
- …In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area ... of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Investigational New Drug (IND), IND amendment, and routine submissions (eg, Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.). ... input to the content of the original label and label updates. + Ensures product packaging and associated information is updated and maintained in accordance with the… more
- Genentech (South San Francisco, CA)
- …a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and Government Affairs) and collaborating across the ... medical experts in their field and will oversee all aspects of medical product support including collaboration with the relevant stakeholders to drive timely data… more
- Langan Engineering, Environmental, Surveying and Landscape… (Santa Barbara, CA)
- …promotes diversity, equity and inclusion; prioritizes wellbeing, health and safety ; encourages volunteerism and philanthropy; offers workplace flexibility, along ... in providing services related to the roles of Principal Investigator , Project Manager, and Crew Lead, and will assist...in the development and achievement of practice goals, continual product service and fiscal growth, and geographic expansion. In… more
- Boehringer Ingelheim (Duluth, GA)
- …needed). + Assists with the evaluation of case data to monitor/identify potential product trends and safety signals. Performs targeted data mining and ... CFR, USDA 9 CFR, and current European regulations. Review, Assess and approve product /adverse event complaints for BIAH products manufactured or sold in the US, and… more
- AbbVie (Mettawa, IL)
- …they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient's journey. The Scientific Director, Medical Affairs ... educational initiatives, scientific communications, value propositioning, and safeguarding patient safety (risk minimization activities and safety surveillance… more
- Bristol Myers Squibb (Summit, NJ)
- …with the ability to work effectively and efficiently on a team while demonstrating safety , quality, and GMP compliance at all times. **Shift Available:** + Sunday - ... through challenges/opportunities. + Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements + Evaluate team… more
- AbbVie (Mettawa, IL)
- …(medical education, data, guidelines, and value proposition); safeguarding patient safety (risk minimization activities and safety surveillance activities). ... with commercial teams to provide strategic medical input into core brand ( product ) strategies, and to support medical and marketing activities (promotional material… more