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Senior Medical Writer
2 months ago
Job Title: Senior Medical Writer - Clinical Research
Job Summary:
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 be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study reports.
Key Responsibilities:
- Develop and maintain a thorough understanding of clinical study design, drug development, and regulatory requirements.
- Collaborate with cross-functional teams, including clinical operations, biometrics, and medical affairs, to ensure seamless document delivery.
- Author, review, and edit clinical study documents, including protocols, informed consent forms, and clinical study reports.
- Provide peer review and quality control of draft and final documents to ensure suitability for external distribution.
- Support the preparation of client meetings and teleconferences, and participate in data-focussed discussions to ensure deliverables are effectively planned and coordinated.
- Work with the project team to proactively identify potential risks and put in place mitigation and contingency plans.
- 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.
- Provide training and guidance to Associate Medical Writers.
- Provide input to the writing, reviewing, and updating of departmental SOPs and associated forms and templates.
Requirements:
- PhD in life sciences, medicine, pharmacy, or a related discipline.
- Minimum of 18 months of experience in a Medical Writing role, preferably in a pharmaceutical company, Contract Research Organisation, or Medical Communications Agency.
- Previous experience working as a Medical Writer on Protocol and CSR projects across Phases 1-3 and various therapy areas, including mental health and psychedelic drugs.
- Knowledge of the regulatory framework that surrounds drug development and the clinical trial process, including the interaction between Medical Writing, Biometrics, and Clinical Operations.
What We Offer:
- Competitive salary in keeping with pharmaceutical industry standards.
- Health Insurance.
- Free onsite parking.
- 25 days annual leave (increasing in increments to 30 days after 6 years' service).
- Your birthday off work.
