Categories
- Accounting/Finance (0)
- Admin/Office/RRHH (2)
- Babysitters (0)
- Cleaning services (0)
- Computers/Internet (0)
- Construction (0)
- Customer service (0)
- Design/Creative (0)
- Education/Teaching (1)
- Hairstylist/Salon (0)
- Home repairs (0)
- Hospitality/Catering (0)
- Logistics/Transport (0)
- Manufacturing (0)
- Medical/Health (2)
- Nonprofit sector (0)
- Private classes (0)
- Sales/Marketing (6)
- Security (0)
- Sports (0)
- Translating (0)
- [Others] (2)
Job offers in nearby cities
Advertising
Job Posting Details
RSSGlobal Safety Exec Medical Director, Safety / CMC - NB50954194
Medical/HealthPosted 22 days 13 hours 34 minutes ago. Viewed: 34 times.
Description
Education: MD degree Must have the ability to travel. Preferred Qualifications: - MD/Ph.D in a biotech-related field (e.g., protein chemistry, molecular biology, pharmacology, toxicology) - Experience with biotech manufacturing and drug safety assessments - Medical device experience - Working knowledge of manufacturing operations and quality systems - Working knowledge of pharm/tox relationships to quality attributes - Working knowledge of risk management processes - Familiarity with forensic investigation practices. The Global Safety Executive Medical Director will provide close medical/safety support to Operations for both product development and commercialization, and will create and maintain a strong cooperative working relationship with both Operations and Safety. The role of developing and maintaining medical/safety subject matter expertise for Operations will be complementary to the role of operations/quality advisor for Safety. Responsiblities include, but are not limited to: - Advise the Quality organization with medical/safety assessments related to non-conformances, product complaints and adverse events - Advise the Quality organization with medical/safety assessments, health hazard evaluation (HHE) related to product actions - Identify quality attributes that may contribute to safety signals - Provide medical/safety assessments for specification changes and specification platforms - Contribute to risk assessments for Operations - Advise and seek input from Safety for quality-related incidents - Develop complex solutions to problems through in-depth analysis, coordination and negotiation with key decision makers - Adapt and integrate own experience with Amgen-wide strategy - Provide expert advice to Sr. Management related to medical/safety issues (product actions) - Support and advise generic and follow-on biologic work streams This position may have direct reports, but will work as an individual contributor 50% of the time. Approximately 20-30% travel.
Industry: Biotech/Pharma
Discipline: Biotech, Pharma, Med. Device R&D
Compensation: $100K+
Company: Amgen Inc
