Precision Medicine Group
healthcare
Director,IVDRegulatoryConsulting
“Director, IVD Regulatory Consulting at Precision Medicine Group. Skills: Regulatory affairs, Consulting, Business development. Apply expertise in regulatory affairs. Manage quality systems”
Industry & Context.
solve difficult problems with effective solutions
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences or equivalent work experience, Minimum 5 years of applicable consulting experience with a focus in regulatory affairs, Minimum of 7 years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment, written and verbal communication skills, leadership, team building and interpersonal skills, business and financial acumen, scientific and analytical skills, Ability to think outside of the box and solve difficult problems with effective solutions, Direct experience working with small and large companies to design global regulatory and commercialization strategies, Experience managing staff members and project teams
Nice to Have
Master's degree
What You'll Do.
Apply expertise in regulatory affairs
Manage quality systems
Oversee marketing authorization process
Direct preparation of submissions
Design strategic approaches to regulatory approvals
Review analytical and clinical protocols
Identify and collaborate with external experts
Review program essential tools
Edit regulatory communication documents
Apply quality systems expertise
Generate new business
Design customized program recommendations
Support evaluation of requests for proposals
Advise on work orders
Assist with client bid defense meetings
Be the regulatory compliance subject matter expert
Convert new business prospects
Identify client needs
Stay abreast of regulatory developments
Support go to market strategy
Review standardized start-up procedures
Ensure quality and integrity of client work
motivate and develop staff
How You'll Work.
Team & Collaboration
Collaborate with external thought-leaders and technical experts; Work in partnership with the business development team; Assist the business development team with client bid defense meetings; Collaborate with the business development account management team
Communication Scope
written and verbal communication skills; regulatory communication
Process & Methodology
Manage project plans, Manage timeline documents
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