Senior/Principal Medical Writer is a 12-month fixed-term, home-based role in the UK or Europe, working fully dedicated to a Top-5 pharmaceutical company through ICON plc, the world’s largest clinical research organization. The role involves independently authoring complex regulatory and clinical documents while collaborating with stakeholders and driving project strategies.
What You'll Do
- Independently author most study-level documents at simple to complex levels, for example: Protocol, protocol outlines
- Independently author Subject Information/Informed Consent
- Independently author Clinical study reports (CSRs)
- Independently author Lay summaries of clinical trial results
- Independently author Investigator brochures (IBs)
- Provide support to more experienced writers with the preparation of submission and other complex clinical documents
- Capable of interpreting and summarizing data
- Drive discussions, ensure decisions are taken and incorporate project strategies in documents
- Lead meetings and drive decisions concerning project/trial-specific medical writing issues
- Responsible for all medical writing aspects of task finalization including stakeholder alignment, coordination, and adherence to timelines
- Represent MW in relevant project groups (e.g., trial squads, M&S team, Clinical Submission Team, Publication Planning Group)
- Work independently and demonstrate resourcefulness (refers to SOPs, guidance documents, and training before reaching out to others for answers to questions relating to medical writing procedures, etc.)
What We're Looking For
- Experienced in writing regulatory documents for pharma or CRO, such as protocols, CSRs, IBs
- Submission experience (or components of submission)
- Project Management of own MW projects
- Highly pro-active team player
- Skilled in building and maintaining good working relationships with stakeholders and colleagues
- Strong engagement with stakeholders to understand and align on the purpose/strategy, timing, and scope of MW tasks
- Strong facilitation, communication and problem-solving skills to effectively manage interactions with all stakeholders and drive decision making
Benefits & Compensation
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
A competitive salary is offered for this role.
Work Mode
Home based, local to the UK or Europe.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. We’re dedicated to providing an inclusive and accessible environment for all candidates.
