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