Medical Writing Lead, Global Clinical Operations, Orion Pharma

Job Description

Orion Pharma is a purpose-driven biopharmaceutical company committed to advancing innovative treatments for cancer patients worldwide. As we expand our global footprint, we are seeking a highly experienced and motivated Medical Writing Lead to join our Global Clinical Operations function and play a pivotal role in shaping the future of cancer care. This role is responsible for overseeing the creation and delivery of clinical documents across all phases of drug development and global regulatory submissions, ensuring quality and compliance through leadership and collaboration.

The Medical Writing Lead drives and oversees the planning, preparation, and delivery of high-quality clinical documents from early-stage development (Phase 1) through late-stage development and global regulatory submissions (NDA/BLA/MAA).

This role combines leadership, oversight of document preparation, scientific expertise, cross-functional collaboration, and operational excellence to ensure timely, accurate, and compliant documentation. The Medical Writing Lead is also responsible for process optimization and continuous improvement.

Main Responsibilities of the role

Leadership

Serve as the primary medical writing lead for one or more clinical programs, ensuring document strategy aligns with clinical, regulatory, and organizational objectives.

Provide day-to-day leadership for medical writing activities across assigned programs

Shape and maintain writing standards, templates, and best practices to ensure consistency and quality across all deliverables.

Provide expert guidance to cross functional teams on document expectations, structure, messaging, and delivery timelines.

Represent Medical Writing in operational planning, clinical development teams and Study teams and cross functional working groups, where applicable.

Document development & ownership:

Lead and/or author high-quality clinical documents, including Protocols & amendments, Clinical Study R