Job Summary
A global biopharmaceutical company has a current position open for a Remote Associate GDS Device SOP Director and Training Lead.
Must be able to:
- Lead the development of GDS operating standards and processes across the product portfolio
- Develop device SOPs, process maps, forms, templates, guidelines and other documentation
- Monitor the impact of any business process or regulatory changes on device SOP documentation
Applicants must meet the following qualifications:
- Up to 30% travel required
- Minimum of 10 years (or equivalent industry experience) in a drug safety environment with at least 5 years of device / combination product expertise
- . Previous pharmaceutical, medical/clinical/laboratory or other scientific experience required
- Proven experience successfully leading cross functional global teams in SOP and training
- Significant experience in managing multiple, highly complex projects
- Strong communication skills including demonstrated ability to influence effectively and implement change in complex matrix organizations
