Medical Writing Director
22 hours ago
We are seeking a highly experienced Senior Manager, Medical Writing to lead our team in creating and maintaining clinical documents. The successful candidate will work closely with project teams to ensure compliance with regulations and standards.
Key Responsibilities:
- Produce high-quality writing deliverables on time and within budget.
- Plan, write, edit, and format key clinical documents independently or as part of a team.
- Manage the review and finalization process for documents to meet regulatory requirements.
- Represent Medical Writing on project teams and collaborate with the Director of Medical Writing.
- Work effectively with various internal and external stakeholders to achieve project goals.
- Serve as a subject matter expert for clinical document production and contribute to the development of SOPs and templates.
Requirements:
- Bachelor's degree in Life Science or English/Communications with relevant expertise.
- Minimum 5 years of experience as a medical writer, preferably with regulatory submissions.
- Knowledge of Good Clinical Practices, FDA regulations, and the drug development process.
- Ability to manage multiple projects in a fast-paced environment and prioritize tasks effectively.
- Strong attention to detail and timely completion of assignments.
- Proficiency in Microsoft Windows, Word, Excel, and PowerPoint.
- Ability to travel approximately 10% for business meetings and conferences.
Compensation:
The estimated salary for this position is $120,000 - $150,000 per annum, depending on experience. Benefits include health insurance, retirement plan, and paid time off.
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Senior Manager, Medical Writing
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West Berkshire, United Kingdom Proclinical Staffing Full timeProclinical is seeking a Senior Manager, Medical Writing. This role will work closely alongside the project teams to create and maintain clinical documents, ensuring compliance with regulations and standards. The successful candidate will also oversee contract writers and contribute to the planning and resourcing of writing deliverables....
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