Syneos Health/ inVentiv Health Commercial LLC
Strategy Lead, Global Risk Management and REMS
Syneos Health/ inVentiv Health Commercial LLC, Bridgewater, New Jersey, United States,
DescriptionAn 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.ResponsibilitiesGlobal Risk Management and REMS Strategy (inclusive of Submission, Assessment)
Establish and maintain the GRMR Strategy approach, structure, and goalsOversee 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 coachingProvide subject matter expertise to project teams as they conduct activitiesAdvise project teams on responses to FDA information requestsResponsible for the development of deliverables associated with REMS submission and assessment activitiesResponsible for all program level planning and coordination associated with REMS submission and assessment activitiesMaintain effective training program for GRMR Strategy activities.Maintain awareness of project activities and help teams resolve operational issues as requiredAttend applicable project meetings and face to face client meetings as requiredParticipate in GRAS, Med Affairs and other projects as requiredMaintain 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 projectsParticipate in sponsor/regulatory audits as requiredAchieves billable utilization and managed book of business targets in service to client engagementsOther duties as assigned
REMS Industry
Builds significant relationships across the brand and generic pharmaceutical industry, to develop future GRMR opportunitiesMonitor all relevant legislation, regulations, guidance, and best practices affecting FRS services.Be an active member of the REMS Industry Consortium and similar industry groupsParticipate 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 activitiesDevelop TL itemsCollaborate with internal cross-functional partners to advance GRMR awareness and represent GRMR solution in broader corporate initiativesRepresent 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 requiredProvide input into proposals and budgets
Global Risk Management
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 marketsDemonstrates 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.
QualificationsAdvanced degree in a science/health care field15+ years of experience working in the pharmaceutical, life science or consulting industries, with at least 5 years senior leadership experience working in GxP organizationsSignificant experience working with REMS programs, strong knowledge of the relevant REMS legislative and FDA guidance environment, and GvP quality systemsDirect experience interfacing with FDA Division of Risk Management and FDA inspectorsSkilled in directing the work of others and driving resultsDisplays a strategic mindset and seeks innovative solutionsAptitude for translating ambiguity and uncertainty into actionable next steps through resourcefulness, resiliency, and adaptabilityCritical thinking and problem-solving skillsExceptional interpersonal and collaboration skillsAbility to assess client needs and deliver high-quality, effective communicationsKnown authority in the market; able to leverage external network to improve profitable revenues and market positioningTalent for growing and developing key client and internal relationshipsDemonstrated competency working with high performing, customer-focused teamsThe annual base salary for this position ranges from $191,335 to $258,865. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.Why Syneos Health?
Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.
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Establish and maintain the GRMR Strategy approach, structure, and goalsOversee 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 coachingProvide subject matter expertise to project teams as they conduct activitiesAdvise project teams on responses to FDA information requestsResponsible for the development of deliverables associated with REMS submission and assessment activitiesResponsible for all program level planning and coordination associated with REMS submission and assessment activitiesMaintain effective training program for GRMR Strategy activities.Maintain awareness of project activities and help teams resolve operational issues as requiredAttend applicable project meetings and face to face client meetings as requiredParticipate in GRAS, Med Affairs and other projects as requiredMaintain 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 projectsParticipate in sponsor/regulatory audits as requiredAchieves billable utilization and managed book of business targets in service to client engagementsOther duties as assigned
REMS Industry
Builds significant relationships across the brand and generic pharmaceutical industry, to develop future GRMR opportunitiesMonitor all relevant legislation, regulations, guidance, and best practices affecting FRS services.Be an active member of the REMS Industry Consortium and similar industry groupsParticipate 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 activitiesDevelop TL itemsCollaborate with internal cross-functional partners to advance GRMR awareness and represent GRMR solution in broader corporate initiativesRepresent 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 requiredProvide input into proposals and budgets
Global Risk Management
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 marketsDemonstrates 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.
QualificationsAdvanced degree in a science/health care field15+ years of experience working in the pharmaceutical, life science or consulting industries, with at least 5 years senior leadership experience working in GxP organizationsSignificant experience working with REMS programs, strong knowledge of the relevant REMS legislative and FDA guidance environment, and GvP quality systemsDirect experience interfacing with FDA Division of Risk Management and FDA inspectorsSkilled in directing the work of others and driving resultsDisplays a strategic mindset and seeks innovative solutionsAptitude for translating ambiguity and uncertainty into actionable next steps through resourcefulness, resiliency, and adaptabilityCritical thinking and problem-solving skillsExceptional interpersonal and collaboration skillsAbility to assess client needs and deliver high-quality, effective communicationsKnown authority in the market; able to leverage external network to improve profitable revenues and market positioningTalent for growing and developing key client and internal relationshipsDemonstrated competency working with high performing, customer-focused teamsThe annual base salary for this position ranges from $191,335 to $258,865. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.Why Syneos Health?
Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.
#J-18808-Ljbffr