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 small-to-medium operational projects (e.g., workflow standardization, tracker/system enhancements, training rollouts).
- Support broader Global Medical Affairs Operations initiatives, including intranet/newsletter content, training materials, and cross-functional operational handoffs.
- Provide operational/administrative support as needed (e.g., vendor/contract support, purchase order support, Medical Affairs system support).
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
- A minimum of 5 years of progressively responsible experience in Project Management, preferably within Medical Affairs, or equivalent experience and/or education
* Special knowledge or skills needed and/or licenses or certificates required.
- Demonstrated ability to operate independently and collaboratively in a fast-paced, matrixed environment with multiple internal and external stakeholders, including the ability to engage and communicate effectively with external stakeholders such as health care professionals (HCPs) and key opinion leaders (KOLs) in a consistently professional manner.
- Strong project management capability: planning, prioritization, timeline management, stakeholder communication, and proactive issue/risk management.
- High attention to detail and strong documentation discipline; ability to maintain inspection-ready records and trackers.
- Excellent organizational and time-management skills with ability to manage multiple workstreams concurrently.
- Strong analytical thinking and problem-solving skills; ability to adapt to shifting priorities and deadlines.
- Professional, clear written and verbal communication skills; ability to communicate status, risks, and next steps effectively.
- Proficiency in Microsoft Office Suite, particularly Excel and PowerPoint.
* Special knowledge or skills and/or licenses or certificates preferred.
- Comprehensive knowledge of the pharmaceutical, biotechnology, or related sectors, including industry-specific practices and regulations.
- Experience supporting early access/compassionate use/non-funded access pathways and related cross-functional coordination.
- Experience using workflow/request management systems (e.g., request portals, case management tools, or similar) and building operational dashboards/trackers.
- undefined
* Travel and Physical requirements
- 5% (to Global Medical Meetings)
- Hybrid/Office based position
Expected Hourly Range: $56-$90/hour. The hourly salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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