Head of Medical Writing, Global Clinical Operations, Orion Pharma in Cambridge

The Head of Medical Writing provides strategic, scientific, and operational leadership for the Medical Writing function and is accountable for delivering high‑quality clinical and regulatory documents across the entire development lifecycle, from First‑in‑Human studies through global registration and life‑cycle management activities. The role combines functional leadership with direct program‑level contribution.

The incumbent serves as the Head of Medical Writing and primary author for one or more clinical development programs, while overseeing medical writing activities across all company‑sponsored studies and regulatory submissions. The Head establishes and executes the global medical writing strategy, builds and leads internal and external medical writing capabilities, and ensures timely preparation of clear, scientifically robust, and regulatory‑compliant documentation in support of clinical development programs and global regulatory submissions. Given the company’s oncology‑focused portfolio, the role requires extensive experience in oncology drug development and deep understanding of evolving regulatory expectations for innovative oncology therapies. The Head also leads process optimization and continuous improvement efforts.

• Functional Leadership
  • Provide strategic leadership and oversight for the Medical Writing function.
  • Develop and implement the medical writing strategy to support clinical development, regulatory submissions, and corporate objectives.
  • Establish and maintain standards, processes, templates, and best practices to ensure consistency, efficiency, and quality across all medical writing activities.
  • Build, develop, mentor, and manage internal and external medical writing resources.
  • Lead resource planning, budgeting, and vendor oversight for medical writing activities.
  • Represent Medical Writing in operational planning, clinical development teams, and cross‑functional working groups, governance committees where applicable.
  • Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.
• Program Medical Writing & Regulatory Submission Leadership
  • Serve as the Head of Medical Writing and primary medical writer for one or more strategic clinical development programs, providing leadership for the planning, development, review, and delivery of clinical and regulatory documentation across the product lifecycle.
  • Develop and execute integrated document and submission strategies aligned with clinical development plans, regulatory objectives, and key program milestones.
  • Personally author, co‑author, review, and approve high‑quality clinical and regulatory documents, including protocols, investigator’s brochures, clinical study reports, health authority briefing packages, regulatory submissions, and responses to regulatory authorities.
  • Lead medical writing activities supporting global regulatory submissions and health authority interactions, including INDs, CTAs, Orphan Drug Designation applications, expedited regulatory pathways (Fast Track, Breakthrough Therapy, PRIME), NDA/BLA/MAA submissions, and lifecycle management activities.
  • Ensure consistency of scientific messaging, clinical positioning, benefit‑risk communication, and data interpretation across programs, regulatory submissions, and external communications.
  • Provide strategic guidance on regulatory messaging and document development to effectively communicate the scientific rationale, clinical value proposition, and development strategy.
• Document Development & Ownership
  • Lead oversight, review, and direct authoring for high‑quality clinical and regulatory documents.
  • Write Safety Narratives and Publications as required.
  • Drive document planning, review cycles, and stakeholder alignment to ensure timely delivery of submission‑ready documentation.
  • Organize and perform quality control checks in alignment with ICH, GCP, and internal SOPs.
  • Ensure all documents meet the highest standards of scientific accuracy, quality, and regulatory compliance.
  • Provide medical writing leadership for oncology programs spanning First‑in‑Human, dose‑escalation, dose‑expansion, proof‑of‑concept, and registrational studies.
  • Support programs involving immuno‑oncology, targeted therapies, precision oncology approaches, biomarkers, and combination regimens.
  • Partner with clinical and translational teams to effectively communicate complex oncology data and development strategies.
  • Maintain awareness of evolving oncology regulatory requirements, industry standards, and scientific advancements.
  • Collaborate closely with Clinical Development, Biostatistics, Data Management, Regulatory Affairs, Safety, and all stakeholders to ensure smooth and timely documentation delivery.
  • Drive efficient document planning and review processes across multiple stakeholders.
  • Resolve scientific and operational issues impacting submission quality or timelines.
  • Ensure alignment and consistency of messaging across studies, programs, publications, and regulatory submissions.
• Oncology Expertise
  • Lead medical writing for oncology programs spanning all phases of clinical development.
  • Support programs involving immuno‑oncology, targeted therapies, precision oncology approaches, biomarkers, and combination regimens.
  • Communicate complex oncology data and development strategies effectively with clinical and translational teams.
  • Stay current with evolving oncology regulatory requirements, industry standards, and scientific advancements.
• Cross‑Functional Collaboration
  • Collaborate closely with Clinical Development, Biostatistics, Data Management, Regulatory Affairs, Safety, and all stakeholders to ensure smooth and timely documentation delivery.
  • Drive efficient document planning and review processes across multiple stakeholders.
  • Resolve scientific and operational issues impacting submission quality or timelines.
  • Ensure alignment and consistency of messaging across studies, programs, publications, and regulatory submissions.
  • Ensure compliance with ICH guidelines, GCP, company SOPs, and global regulatory requirements.
• Process, Quality and Continuous Improvement
  • Ensure compliance with ICH guidelines, GCP, company SOPs, and global regulatory requirements.
  • Maintain inspection readiness for medical writing deliverables.
  • Drive continuous improvement initiatives to enhance quality, consistency, efficiency, and scalability.
  • Evaluate and implement innovative technologies, automation, and AI‑enabled solutions to improve document development and review processes.
  • Monitor industry trends and evolving regulatory expectations to continuously strengthen writing practices.

This role is based in Cambridge (MA), US and reports to VP, Global Clinical Operations.

• Inclusive work environment.
• Opportunities for professional growth and development.
• Chance to be part of a mission‑driven organization.

• Advanced degree in life sciences (PhD, PharmD, MD, or MSc).
• 10‑15+ years of medical writing experience within biotechnology, pharmaceutical, or CRO environments.
• Deep expertise in oncology drug development, including early‑stage and late‑stage clinical development.
• Extensive experience leading clinical and regulatory writing activities across all phases of drug development.
• Strong experience supporting major global regulatory submissions, including NDA, BLA, MAA, and related health authority interactions.
• Demonstrated experience leading and developing Medical Writing teams and managing external writing vendors.
• Proven ability to lead complex cross‑functional initiatives and influence senior stakeholders.
• Excellent scientific writing, communication, leadership, and project management skills.
• Strong knowledge of ICH guidelines, GCP, CTD structure, and international regulatory requirements.

• Experience in small biotech and/or fast‑paced growth environments.
• Experience supporting innovative oncology programs including immunotherapies, targeted therapies, radiopharmaceuticals, cell therapies, or other novel modalities.
• Experience leading both clinical and regulatory writing strategies through major registration submissions.

The expected annual salary range for this position is $150,000‑230,000 per year. Final compensation will depend on skills, experience, and job‑related qualifications.