Project Manager, Medical Affairs

Acrotech Biopharma Inc; East Windsor Township (NJ); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Acrotech Biopharma Inc. is seeking a Project Manager for the Medical Affairs team in East Windsor, NJ. The PM will oversee planning, execution, and tracking of Medical Affairs initiatives, ensuring timely, compliant, and high-quality delivery of projects.

This role collaborates with Medical Affairs leadership, Field Medical, and other stakeholders to manage schedules and budgets. The ideal candidate will coordinate cross-functional activities, manage publication timelines, and support medical

Aufgaben

• Coordinate operational activities for Medical Affairs projects including Field Medical activities, advisory boards, IIS, publications, congress activities, 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, dependencies; escalate issues as needed.
• Support calendar of activities including meeting planning and logistics, agendas, materials, minutes, and follow-up actions.
• Support execution of the Medical Affairs scientific communications plan, including coordination of publication timelines, abstracts, posters, manuscripts, and congress deliverables.

Jobbeschreibung

Division Overview

Acrotech Biopharma Inc. was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research-based organization that strives to launch treatments which are accessible to patients that need them. Acrotech Biopharma is focused on building a presence in unmet needs in oncology and dermatology. This is a great time to join Acrotech. We are seeking talented leaders to grow our organization. Here you won’t be just a number, but a key contributor who will make significant impact on our organization and the patients we support.

Job Overview

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; escalation 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