Medical Writer III, Oncology

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Medical Affairs Group – Medical Writing

Spring House, Pennsylvania, United States;
Titusville, New Jersey, United States;
Beerse, Belgium;
Leiden, Netherlands;
High Wycombe/Maidenhead, United Kingdom;
Toronto, Canada;
Spring House / Titusville, United States.

Medical Writer III, Regulatory Medical Writing to support Oncology within our Integrated Data Analytics & Reporting (IDAR) business.

The position may be located Beerse, Belgium;
Leiden, Netherlands;
High Wycombe/Maidenhead, United Kingdom;
Toronto, Canada or Spring House / Titusville, United States. The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case‑by‑case basis and if approved by the company. This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

• Write or coordinate clinical and regulatory documents such as CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Lead cross‑functional (eg, with clinical team) document planning and review meetings.
• Interact with cross‑functional colleagues on document content and champion MW processes and best practices.
• Establish document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Complete all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
• Function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
• Act as the primary point of contact for medical writing activities for the cross‑functional team (eg, clinical).
• Coach or mentor more junior staff on document planning, processes, and content.
• Provide peer review as needed.
• Actively participate in or lead process working groups.
• Lead in a team environment and matrix.
• Provide input into functional tactics/strategy (eg, writing teams, process working groups).

Internal: manager, other writers cross‑functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents. External:
May interact with or oversee day‑to‑day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.

A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience! Oncology therapeutic area experience is preferred. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.

Compound lead…