Strategy Lead, Global Risk Management and REMS

Strategy Lead, Global Risk Management and REMS

Updated : August 23, 2024

Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.

Location : Bridgewater, NJ, United States

Job ID : 5504

An Executive Director in Global Risk Management & REMS (GRMR) is an experienced thought leader in the biopharmaceutical industry and a trusted advisor to clients with accountability for front end strategy services inclusive of submissions, assessment, as well as new GRM solutions, and thought leadership.

Viewed as a key senior leader within the GRMR business, this role will contribute to setting business direction, strategy, and priorities to drive the overall growth and scalability of the GRMR services and capabilities.

They will participate in the GRMR leadership team.

Responsibilities

• Global Risk Management and REMS Strategy (inclusive of Submission, Assessment)
• 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.
• Business Development
• 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.
• Community
• 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.

Qualifications

• 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.

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