VP of Regulatory, Clinical & Quality - partial telecommute
Executive leadership of regulatory, clinical and qualify functions. Oversee globally and provide leadership in these 3 areas, including interacting with regulatory, government and health authorities. Also interface with corporate partners to develop marketing strategies, directing resources to appropriate areas and provide hands on expertise. Travel up to 40%, domestic and international.
Direct, review and provide strategy for regulatory, clinical, quality guidance and related activities ensurance adherence to government contracts and compliance with regulatory and clinical requirements for submissions.
Plan, oversee and support all regulatory submissions including IND, NDA, MAA, CTA (CTx).
Select CRO's and oversee clinical trials from strategic level
Lead the development of regulatory strategy timelines, staff and budgets globally.
Provide international strategy for regulatory compliance, filings, supply chain operations, marketing, sales and external partners
Support sales via communication to stakeholders of regulatory meetings
Review final reports for studies, manufacturing process, investigator brochures, protocols, trial and regulatory documentation
Interact with key medical and scientific leaders in and outside of company
Primary liaison with FDA, EMA, other health authorities
Handle communications of company's position both internally and externally
Evaluate external opportunities for new technologies for regulatory and clinical implications
Manage Regulatory, Quality and Clinical personnel
BS, MD, PhD, PharmD preferred
15 years of pharmaceutical industry experience with emphasis on regulatory affairs, filings, interaction with high levels of health authorities in FDA and other agencies
5 years in clinical and quality
Management experience with direct reports in pharmaceutical industry
In depth knowledge of regulatory strategy for all phases from preclinical to phase 3
GCP, ICH, CFR, GxP knowledge
Prefer small company experience
Partial telecommute - must be willing to spend 50% of time in the office
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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