Medical Writing Lead, Global Clinical Operations, Orion Pharma at Orion Pharma

Cambridge, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

16 Jul, 26

Salary

200000.0

Posted On

17 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical writing, Clinical research, Regulatory submissions, Oncology, ICH guidelines, GCP, Clinical study reports, Protocol development, Regulatory affairs, Scientific writing, Project leadership, Data management, Biostatistics, Document management systems, Quality control, Regulatory strategy

Industry

Pharmaceutical Manufacturing

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 Reports (CSRs), Investigator’s Brochures (IBs) * Support Regulatory consultations & submissions (e.g. INDs, FDA/EMA/PMDA briefing documents, Health Authorities responses, Regulatory summaries, CTD Module 2 and module 5 components) * Write Safety Narratives and Publications (as needed/ applicable) * Drive timelines, manage stakeholder input, and ensure clarity, and regulatory compliance. * Ensure each function will confirm the scientific accuracy of contributed content * Organizing and performing quality control checks and ensure alignment with ICH, GCP, and internal SOPs. Cross Functional collaboration * Partner closely with Clinical Development, Biostatistics, Data Management, Regulatory Affairs, Safety, and all stakeholders within the clinical development project team and study team to ensure smooth and timely documentation delivery. * Facilitate efficient review cycles, resolve content or interpretation issues, and provide clear guidance to document contributors. * Ensure cohesive scientific messaging and consistency within a document and across documents and programs. Process, Quality and Continuous Improvement * Contribute to the development and maintenance of writing templates, SOPs, style guides, and best practices. * Lead or support internal workshops on writing methodology, regulatory style, or communication best practices. * Support change management and scalable process improvements as the portfolio grows. * Other duties as required. This role can be based in one of the following Global R&D locations: Cambridge UK, Cambridge (MA), US or Espoo in Finland. What We Offer At Orion Pharma, your work contributes to improving health and well-being for patients and society. We foster a culture of respect, diversity, and collaboration, offering: * Inclusive work environment * Opportunities for professional growth and development * A chance to be part of a mission-driven organization Learn more about our values and working culture: https://www.orionpharma.com/careers/working-with-us/what-we-offer/ Our expectations * Advanced degree in life sciences (PhD, PharmD, MD, or MSc). * 7–8+ years of medical writing experience in pharma, biotech, or CRO settings. * Strong experience with clinical and regulatory document development across multiple phases of clinical research. * Experience with global regulatory submissions preparation (NDA/BLA/MAA). * Demonstrated leadership capability, including experience guiding teams or managing complex writing projects. * Exceptional communication, scientific interpretation, and organizational skills. * Experience in oncology, rare disease, or other complex therapeutic areas. * Strong knowledge of ICH guidelines, GCP, and global regulatory frameworks. * Familiarity with document management systems. Preferred * Experience in small biotech and/or fast paced growth environments. * Prior experience of managing professionals or mentoring writers. How to apply Please send your application with the latest CV, cover letter, and salary request in English by April 30th, 2026. The expected salary range for this position is $150 000 - 200 000 per year. Final compensation will depend on skills, experience, and job‑related qualifications. #LI-ORION Orion Pharma’s pharmaceutical innovations are created within its R&D organization. We employ around 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Cambridge and Nottingham in England and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas. Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future. Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more. We offer careers with a clear purpose: empowering people to live their lives to the fullest. About Orion [https://www.orionpharma.com/about-orion/]

Responsibilities

The Medical Writing Lead oversees the creation and delivery of clinical documents across all phases of drug development and global regulatory submissions. This role involves providing leadership to cross-functional teams, ensuring scientific accuracy, and maintaining compliance with regulatory standards.