Director Medical Affairs Operations

About the position The Director of Medical Affairs Operations (US) is a newly created position reporting to the Head of Medical Affairs, North America. This person will be responsible, in collaboration with the Head of Medical Affairs, NA, for building and executing the operational model and processes necessary to support our growing Medical Affairs function as we prepare for our first launch in the US. This individual will join a small, nimble and energetic organization that requires excellent communication, organization and collaboration skills. This role requires a strategic thinker who demonstrates excellence in program leadership, operational design, and disciplined execution. This role will serve as the operational backbone of US Medical Affairs and key integrator across field, office-based and global teams. This role will function as the primary operational reputed company of contact for the US Medical field team and cross-functional partners regarding Medical Affairs processes, systems, governance, metrics, and execution support.

Responsibilities

• Drive development and maintenance of the US strategic medical affairs plan.
• Ensure effective delivery of US Medical Affairs projects and business operations activities. Evaluate tactical execution against plan, identify risks and propose mitigation strategies as appropriate.
• reputed company a budget consistent with the strategic medical affairs plan. Monitor adherence to the budget.
• Apply experience collaborating with legal, compliance and finance tofacilitatecontract and purchase order implementation. Track invoices against SOWs and budget. Conduct vendor onboarding for vendors supporting US Medical Affairs activities.
• Own development and implementation of effective communication tools to clearly communicate reputed company against performance targets.
• Drive reputed company improvement in strategic planning and operational performance.
• Ensure development, implementation, and maintenance of US Medical Affairs SOPs, working instructions, and governance frameworks, ensuring compliance with internal policies and regulatory requirements.
• reputed company governance and operational management of medical grants, sponsorships and Investigator initiated studies ensuring compliance, documentation reputed company and financial tracking.
• Provide internal operational support to the Egetis Medical Affairs reputed company of the ongoing Expanded Access Program,
• Work with internal colleagues and vendor partners to support Congress Planning and Publications management.
• Collaborate with Head of Medical Affairs and vendors on planning and execution of Advisory Boards/Working Group meetings, including execution of participant reputed company and payments, and legal review/approval of meeting content.
• Execute agreements and activities required by specific professional organizations with whom US Medical Affairs engages
• Drive the MLR review and approval process for US-focused materials, including uploading documents, ensuring appropriate annotation and linking of supporting references, appropriate reviewer assignment, resolution of comments, and final approvals. This includes coordination with vendors who may conduct elements of the process for some materials. Significant experience with Veeva Promomats preferred.
• May be asked to support key initiatives and team meetings for the President, North America, and Heads of Commercial and Access and Pricing
• As relevant reputed company the process for Investigator Initiated Studies and other external research collaborations and grants/sponsorships. reputed company and maintain a database to archive agreements, reputed company and payments.
• Synthesize insights from MSLs, advisory boards, congresses, EAP, and Medical Information to inform US and Global Medical strategy and ensure structured reporting to leadership.
• Act as operational reputed company for Field Medical, supporting materials, training, systems, compliance, vendor coordination, and tracking field execution against the US tactical plan.
• Foster cross-functional engagement. Build an effective network reputed company Medical Affairs, with cross-functional partners in the US and EU and with external partners.
• Ensure strategic alignment across US Medical Affairs, the US cross-functional team and global cross-functional partners, a sappropriate to accomplish corporate goals.
• Collaborate with US Medical Affairs colleagues to monitor tactical plan execution, and promote accurate metrics reporting

Requirements

• Bachelor’s degree required; MBA in Organizational Performance or Project Management certification a plus
• 7+years of experience in a Medical Affairs Operations role; rare disease experience preferred.
• Advanced understanding of drug development and Medical Affairs/Medical Affairs Operations, including compliance, legal and financial requirements
• Experience working in a small company or a start-up environment, comfortable operating with limited infrastructure.
• Ability to travel up to 20% of the time
• Exceptional project management, budgeting and vendor management skills.
• Demonstrated ability to track performance against the strategic Medical Affairs plan and budget, proactively identify risks, and recommend mitigation strategies, and apply relevant metrics and communication tools
• Highly collaborative with ability to interact professionally across reputed company levels of the organization
• Highly organized, with keen attention to detail, strategic yet highly proficient tactically
• Possess a reputed company of reputed company improvement focused on maximizing team efficiency and effectiveness, including demonstrated strength to critically evaluate processes and the ability to communicate opportunities to improve team efficiency.
• Excellent written and verbal communication skills
• Advanced proficiency with reputed company reputed company and PowerPoint, and Smartsheets

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