About The Position

The Director of Global Medical Affairs Program Management Office (GMA PMO) will serve as the head of Medical Governance and Operations. In this role, the Director will work toward standardization of key operational activities across Global Medical Affairs (GMA) and provide Project Management support for the GMA Leadership Team. The Director will also have accountability of the following medical processes: Global and US Medical Review Committee process, Global and US Medical Education Grants Review Committee process, and Global and US Contracting process. This role will work closely across all functions, franchises and regions within Medical, as well as engage with key cross-functional partners including Compliance, Finance, Procurement, Regulatory, Quality, and Commercial. The Director will ensure the delivery of results on-time and within-budget, while driving effective communication within the team and to key stakeholders. As an integral member of the growing PMO and Global Medical Excellence team, the Director will also lead other projects and initiatives to support standardization, optimization, and evolution of medical processes and governance. The ideal candidate is a problem solver who has a strong Medical Affairs Operations background and is able keep the big picture in mind even as they support day-to-day tactics. The candidate must be an excellent communicator and have exceptional skills organizing and synthesizing information. Additionally, the candidate should thrive in an entrepreneurial environment and demonstrate a high level of initiative and resourcefulness.

Requirements

  • BA/BS degree with 10 + years of experience or a Master's or higher with 7 + years of experience within the pharmaceutical, biotech or life sciences industry
  • 6 + years of experience working in a project or program management role or in Medical Operations
  • Industry experience – a strong understanding of the biotech/pharmaceutical industry and previous drug development experience is required.
  • Operational experience within Medical Affairs is required.
  • Analytical Thinking – possesses the ability to breakdown a problem and implement a scalable solution that takes long-term strategy into account
  • Excellence in Execution – ability to execute accurately and with a sense of urgency; strong organizational skills and attention to detail
  • Initiative and Resourcefulness – works independently, anticipates needs to help mitigate problems ahead of time, and solves problems without needing guidance/direction
  • Communication - excellent writing and oral communication skills; ability to present key information objectively and clearly
  • Meeting Management – excellent meeting planning and facilitation skills
  • Project Management – highly proficient at both building and maintaining Gantt charts, tracking systems, spreadsheets and tools that support a systematic and scalable approach to managing projects
  • Problem Solving – A proactive and effective problem solver who works well with others; proven ability to manage complex and challenging situations to drive to clarity
  • Team Player – has a team-oriented approach
  • Business Sense - has a strong business sense and can decipher priorities and make sound judgment calls when needed
  • Proficiency with Microsoft Office applications (e.g., Outlook, Excel, Power Point) is required
  • Proficiency with Smartsheet is preferred, competency is required

Nice To Haves

  • Oncology therapeutic area experience preferred
  • Familiarity with Veeva MedComms, VVQD, Cybergrants are all a plus
  • Project Management certification is a plus
  • Supervisory experience preferred

Responsibilities

  • Manages the Global and US Medical Review Committees and is accountable for the MRC Global Policy and process
  • Manages the Global and US Grants Review Committee process including execution of Medical Education, IME, CME, Grants, Sponsorships and helps to shape the overall process
  • Facilitates the review, approval, and delivery of enterprise and GXP training to Medical Affairs personnel, including during onboarding (excludes scientific training on data, publications, disease-state, and competitors)
  • Lead and support continuous improvements efforts in the PMO by sharing best practices, identifying cross-project and cross-functional opportunities/interdependencies/risks, assessing key performance metrics and establishing standardization across GMA
  • Provide Project Management of GMALT and operational initiatives supporting the GMA Leadership Team, including planning of Global Town Halls and other cross-GMA team meetings
  • Supports Vice President of Global Medical Excellence in management of budgets across GMA
  • Support contracting process in Global and US, ensuring all regions are following best practices
  • Serve as a liaison to key cross-functional partners including Compliance, Finance, Procurement, Regulatory, Quality, and PRC
  • Proactively identifies critical milestones, interdependencies, risks and resource constraints that could impact plans/timelines and collaborates with teams to develop appropriate solutions
  • Creates and maintains project timelines that are critical tools for tracking progress against goals; closely and transparently manages the critical path of projects
  • Effectively communicates actions, decisions, timelines, risks and changes to plans
  • Effectively manages and/or facilitates various meetings and manages meeting documentation (agendas, minutes, action/decision trackers, etc.)
  • Drives use of consistent project management tools and practices
  • Partners with non-GMA stakeholders (e.g., Finance, Procurement, etc.) to drive execution
  • Effectively and quickly establishes rapport with all key internal/external partners and stakeholders and influences without authority
  • Optimizes communication within and between teams, in and outside of meetings, and at varying organizational levels
  • Develops and delivers critical presentations to communicate medical processes and governance
  • Adept at learning new technologies and platforms
  • Ensure compliance with corporate policies and procedures, as well as US healthcare laws and regulations

Benefits

  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness
  • annual bonus plan
  • incentive compensation plan
  • discretionary equity awards
  • Employee Stock Purchase Plan
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