Medical Writing Lead, Global Clinical Operations, Orion Pharma
Orion Corporation, Cambridge, MA, United States
Medical Writing Lead, Global Clinical Operations, Orion Pharma
Cambridge, United Kingdom and 3 more (Hybrid)
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.
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, study teams, and cross‑functional working groups, where applicable.
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.
Organize and perform quality control checks and ensure alignment with ICH, GCP, and internal SOPs.
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
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.
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.
Locations: Bennett building B930 Babraham Research Campus, Cambridge, CB22 3AT, GB
Orionintie 1 A, Espoo, 02200, FI
One Broadway, Cambridge, Massachusetts, 02141, US (Hybrid)
#J-18808-Ljbffr
Cambridge, United Kingdom and 3 more (Hybrid)
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.
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, study teams, and cross‑functional working groups, where applicable.
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.
Organize and perform quality control checks and ensure alignment with ICH, GCP, and internal SOPs.
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
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.
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.
Locations: Bennett building B930 Babraham Research Campus, Cambridge, CB22 3AT, GB
Orionintie 1 A, Espoo, 02200, FI
One Broadway, Cambridge, Massachusetts, 02141, US (Hybrid)
#J-18808-Ljbffr