Clinical Writing Leader
1 mese fa
Job Title:
Clinical Writing Leader
Location: Belgium-Wavre, Italy - Siena
Salary: Estimated €80,000 - €110,000 per year (dependent on qualifications and experience)
Job Description:We are seeking a highly skilled Clinical Writing Leader to join our team at GlaxoSmithKline. As a key member of our medical writing department, you will be responsible for leading therapy area specific medical writing projects or programs in support of the clinical strategy.
Responsibilities:
- Contribute to clinical strategy development, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents such as protocols, clinical study reports, and clinical study register summaries.
- Lead matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed.
- Evaluate global approaches for submissions as necessary, ensuring alignment with business needs and regulatory requirements.
- Develop and implement effective plans for complex situations, applying scientific, operational, and submission development knowledge to identify and implement solutions.
- Propose resourcing solutions for major projects, including number of FTEs required and best use of internal and external resources.
- Organize content and argument in complex clinical submission documents, including briefing documents and responses to regulatory questions.
- Contribute to the development of training materials for therapeutic area scientists and provide mentoring and/or training on clinical documentation and submission planning.
Requirements:
- Master's degree in any scientific related field.
- Hands-on experience with medical writing and clinical regulatory document preparation.
- Demonstrated experience managing multiple strategic partnerships.
- Experience or exposure to submission documents.
- Strong leadership skills to guide and motivate team members.
- Excellent communication skills to interact effectively with different stakeholders.
- Fluency in English is mandatory, with any additional language being an asset.
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