Project Manager, Medical Affairs

Project Manager

The Project Manager (PM) is part of the Medical Affairs team based in East Windsor, NJ, residing in Acrotech's home office headquarters and reporting to the Head of Medical Affairs. The PM is responsible for overseeing and supporting the planning, execution, and tracking of Medical Affairs initiatives to ensure timely, compliant, and high-quality delivery of projects. The PM will partner closely with the Medical Affairs leadership and the Field Medical team to drive and own the creation, maintenance, and oversight of project schedules, manage project budgets, and serve as the primary point of contact, working cross-functionally with our internal stakeholders. This role requires a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, scientific standards, and meaningful differentiation for medical practice adoption.

Responsibilities

Project Coordination and Execution

• Coordinate operational activities for Medical Affairs projects, including (but not limited to) Field Medical activities, advisory boards, investigator-initiated studies (IIS) (internal review committee, processing, SUSAR, and approval(s)), publications, congress activities, medical sponsorships, medical education programs, and internal initiatives.
• Develop and maintain project plans, timelines, trackers, and status reports to support on-time execution.
• Monitor milestones, deliverables, risks, and dependencies; escalate issues as needed.
• Support a calendar of activities including meeting planning and logistics, agendas, materials, minutes, and follow-up actions.
• Support the execution of the Medical Affairs scientific communications plan, including coordination of publication timelines, abstracts, posters, manuscripts, and congress deliverables.

Cross-Functional Collaboration

• Serve as a central point of contact between Medical Affairs and cross functional stakeholders (Marketing, Compliance, Legal, Finance, Pharmacovigilance (PV), Operations, and Clinical Development).
• Facilitate communication and alignment across teams to ensure clarity on roles, responsibilities, and timelines.
• Coordinate with vendors, agencies, and external partners to raise POs, ensure deliverables meet quality, budget, and timeline expectations.
• Support contract development and execution including SOWs, consulting agreements, and vendor contracts; ensure appropriate documentation and approvals are obtained.
• Support medical research activities by coordinating study drug access (when applicable), tracking study progress, and supporting close-out activities.
• Partner with Medical Information to support development, review, and lifecycle maintenance of medical response documents (e.g., FAQs, standard response letters, scientific response documents)
• Collaborate with Medical Information and Pharmacovigilance teams to coordinate the triage and routing of medically relevant inquiries and safety information, ensuring appropriate documentation and escalation pathways are followed.
• Partner with internal and external stakeholders to track publication development, approvals, and submission timelines.

Process, Compliance and Documentation

• Ensure Medical Affairs activities are conducted in compliance with internal policies, SOPs, and external regulations, including applicable transparency reporting and fair market value (FMV) processes.
• Maintain accurate, inspection-ready documentation including approvals, contracts, project files, medical review documentation, and study tracking records.
• Support IIS governance activities including internal committee review logistics, processing timelines, SUSAR coordination, and approval documentation.
• Develop, maintain, and routinely update a centralized publications database for all products, including peer-reviewed manuscripts, congress abstracts, posters, and internal scientific references, ensuring version control and accessibility for internal stakeholders.

Reporting and Operational Support

• Develop and maintain dashboards and operational metrics to track Medical Affairs execution, resourcing, and performance against objectives.
• Support annual planning, budget forecasting, invoice processing, and financial tracking for Medical Affairs programs in collaboration with Finance.
• Identify opportunities to improve Medical Affairs workflows, project execution efficiency, and operational best practices.

Qualifications - Skills & Requirements

• 1-2 years of experience in project coordination, operations, administrative support within pharmaceutical, biotech, CRO, or healthcare environments. Familiarity with Medical Affairs activities such as advisory boards, congress planning, or IISs is a plus.
• Strong organizational skills with time management and the ability to work independently and manage multiple projects simultaneously.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word), experience with Veeva, Monday, and Sharepoint is a plus.
• Excellent written and verbal communication skills, with high attention to detail and the ability to work in a regulated environment.
• Experience working with cross-functional and matrixed teams, as well as stakeholder communication and collaboration, problem solving and proactive engagement.

Education & Experience

• Bachelor's degree in life sciences, healthcare, business, or related field. Advanced degree is a plus.