Senior Medical Writer
4 days ago
We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will play a critical role in the development and delivery of high-quality clinical study documents, including protocols, investigator brochures, informed consent forms, and clinical study reports.
Key Responsibilities- Lead the development and review of clinical study documents, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Collaborate with cross-functional teams, including biometrics, clinical operations, and sponsors, to ensure seamless document delivery.
- Provide mentoring and guidance to junior medical writers, ensuring they have the necessary skills and knowledge to produce high-quality documents.
- Manage document review cycles, comment resolution, and incorporation to ensure inclusion of relevant input.
- Quality control - Provide peer review and quality control of draft and final documents against approved sources to ensure suitability for external distribution.
- Support the preparation of, or act as the Medical Writing lead in, client meetings and teleconferences.
- Participate and, where necessary, lead data-focussed discussions, collaborating with the project manager and project team to ensure deliverables are effectively planned, coordinated, and delivered.
- Work with the project team to proactively identify potential risks and suggest mitigation and contingency plans.
- Confidently drive medical writing discussions and lead key meetings with subject matter experts to deliver regulatory documents on time and to high quality.
- Review and provide input into project plans and documentation such as the Clinical Trial Design, Data Management Plan, Statistical Analysis Plan, Tables Figures and Listings.
- Mentor and support other members of the project team as needed.
- Provide training and guidance to less experienced Medical Writers.
- Write, review, and update departmental SOPs and associated forms and templates.
- Educated to Bachelor's degree level or higher, preferably in life sciences, medicine, pharmacy, or a related discipline.
- Experience of clinical study design and optimization, knowledge of drug development, and experience in regulatory writing for a clinical research organization, industry, and pharmaceutical company.
- Knowledge of or experience in the conduct of clinical trials.
- Proven expertise in science and/or healthcare and knowledge of risk-benefit.
- Ability to read, analyze, and interpret complex scientific and clinical information and write a clear, succinct summary targeted at the relevant audience.
- Experience with mathematical concepts such as probability and statistical inference.
- Ability to write articles for peer-reviewed publications that conform to the prescribed journal style and format.
- Ability to work and lead in a collaborative team environment and support colleagues to achieve high-quality outcomes.
- Well-organized, flexible, and able to plan multiple projects and work effectively to tight deadlines.
- Excellent interpersonal skills, including written English and clear oral communication.
- A keen eye for detail across scientific content, consistency, and editorial standards and the ability to coach others in editorial review.
- Ability to manage and prioritize multiple projects simultaneously and to supervise the work of more junior writers.
- Computer literate - Word, PowerPoint, Excel, Teams, Sharepoint, Adobe.
- MSc or PhD in life sciences, medicine, pharmacy, or a related discipline.
- Previous experience of Medical Writing in a clinical research environment and knowledge of the relevant regulatory requirements.
- Previous experience working as lead Medical Writer on Protocol, IB, CSR, and/or regulatory dossiers across Phases 1-3 and in various therapy areas, including mental health and psychedelic drugs.
- Experience in the technical aspects of document formatting and preparation, the use of Adobe Acrobat for signatures and manipulation of PDFs, the use of a reference manager, and collaborative authoring tools.
- Experience working to the rigorous global regulatory standards required for drug development and the clinical trial process, including experience interacting with colleagues and Subject Matter Experts across Biometrics, Clinical Operations, and Sponsor organizations.
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