Contractor, Global Medical Affairs Operations

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: www.ptcbio.com Job Description Summary: The Contractor, Global Medical Affairs Operations plays a pivotal role in the end-to-end operational execution and continuous improvement of PTC’s Access to Therapies (PTC-ACTS) non-funded/compassionate use request process. This position substantially supports the administration, tracking, and coordination of ACTS requests in alignment with applicable regulatory requirements and company Standard Operating Procedures (SOPs), including the SOP governing management of non-funded access requests. The role is highly project-management oriented, requiring strong planning, cross-functional coordination, risk/issue management, and stakeholder communication to ensure requests are progressed efficiently. In addition to ACTS ownership, the contractor supports broader Global Medical Affairs Operations initiatives and administrative activities. Job Description: ESSENTIAL FUNCTIONS Primary duties/responsibilities: Serve as a primary operational support for ACTS (non-funded access/compassionate use) requests, ensuring consistent, timely, and compliant execution of the defined process. Ensure adherence to applicable regulatory requirements and PTC SOPs is essential in all ACTS activities. Drive close cross-functional collaboration to enable timely execution, decisioning, and follow-up across the ACTS workflow. Manage intake, triage, routing, and follow-up of ACTS requests received through established channels. Maintain accurate, audit-ready request records in the designated system (e.g., ACTS-Encompass), including status updates and document management. Coordinate cross-functional stakeholder engagement as required to enable feasibility assessments and operational planning (e.g., Regulatory, Supply Chain, Quality Operations, Legal, Finance, Pharmacovigilance, Country/Regional Medical Affairs representatives; and other ad hoc stakeholders as needed). Track milestones, timelines, dependencies, and bottlenecks; escalate risks proactively. Prepare and communicate status summaries and operational updates to support transparent, timely internal decision-making. Maintain and update ACTS templates, trackers, job aids, and process documentation in line with SOP/system changes. Support inspection/audit readiness through complete, traceable documentation and compliant record retention. Identify process gaps and drive continuous improvement to enhance efficiency, compliance, and stakeholder experience. Lead/coordinate…