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Company

Syneos Health Commercial Solutions · 18 hours ago

Strategy Lead, Global Risk Management and REMS

United States

Full-time

Remote

Director/Executive

$191K/yr - $259K/yr

15+ years exp

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Responsibilities

Establish and maintain the GRMR Strategy approach, structure, and goals

Oversee project schedules and resource allocations for all GRMR Strategy projects and drive successful delivery of project commitments.

Build and/or evolve a high-performing team, find and nurture talent, maintain succession plans, and provide performance coaching

Provide subject matter expertise to project teams as they conduct activities

Advise project teams on responses to FDA information requests

Responsible for the development of deliverables associated with REMS submission and assessment activities

Responsible for all program level planning and coordination associated with REMS submission and assessment activities

Maintain effective training program for GRMR Strategy activities.

Maintain awareness of project activities and help teams resolve operational issues as required

Attend applicable project meetings and face to face client meetings as required

Participate in GRAS, Med Affairs and other projects as required

Maintain repository of REMS knowledge (e.g. active and retired REMS from FDA website, journal articles, regulations, guidance, etc.)

Business owner of our REMS Genius generative AI application to assist with REMS strategy projects

Participate in sponsor/regulatory audits as required

Achieves billable utilization and managed book of business targets in service to client engagements

Other duties as assigned

Builds significant relationships across the brand and generic pharmaceutical industry, to develop future GRMR opportunities

Monitor all relevant legislation, regulations, guidance, and best practices affecting FRS services.

Be an active member of the REMS Industry Consortium and similar industry groups

Participate in developing the GRMR annual Thought Leadership (TL) plan (e.g., white papers, case studies, conference presentations, webinars, LinkedIn content etc.) and assist with conducting TL activities

Develop TL items

Collaborate with internal cross-functional partners to advance GRMR awareness and represent GRMR solution in broader corporate initiatives

Represent GRMR at industry events

Participate in Business Development activities, e.g., capabilities presentations, RFI/RFP response, proactive proposals, bid defense, conference presentations, outreach, etc.

Develop content for BD activities as required

Provide input into proposals and budgets

Work across the organization to establish our GRM aRMM implementation and effectiveness strategy, process controls, ways of working, etc.

Help establish our GRM consulting activities focused on Structured Benefit-Risk Assessment, GRMP, DRMP, etc.

Well-respected and visible leader within the company. Viewed as positive role model for teams and enjoyable to work for / with. Displays the passion and drive of a business owner.

Actively builds relationships with leaders across business and other areas within Syneos Health.

Involved in internal recruitment, training, and retention initiatives.

Drives a positive, collaborative, and professional team culture through words, attitude, and actions.

Proactively seeks opportunities to expand knowledge of the biopharmaceutical industry, GRMR service offerings, and client products and markets

Demonstrates Syneos Health core values in action and word and holds other team members accountable to company values, as well: challenge the status quo, collaborate to deliver solutions, and passionate to change lives.

Qualification

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Advanced degreeREMS programsFDA guidanceGxP organizationsFDA Division of Risk ManagementFDA inspectorsClient needs assessmentMarket authorityClient relationship managementHigh performing teamsCollaboration skillsHigh-quality communication

Required

Advanced degree in a science/health care field

15+ years of experience working in the pharmaceutical, life science or consulting industries, with at least 5 years senior leadership experience working in GxP organizations

Significant experience working with REMS programs, strong knowledge of the relevant REMS legislative and FDA guidance environment, and GvP quality systems

Direct experience interfacing with FDA Division of Risk Management and FDA inspectors

Skilled in directing the work of others and driving results

Displays a strategic mindset and seeks innovative solutions

Aptitude for translating ambiguity and uncertainty into actionable next steps through resourcefulness, resiliency, and adaptability

Critical thinking and problem-solving skills

Exceptional interpersonal and collaboration skills

Ability to assess client needs and deliver high-quality, effective communications

Known authority in the market; able to leverage external network to improve profitable revenues and market positioning

Talent for growing and developing key client and internal relationships

Demonstrated competency working with high performing, customer-focused teams