Clinical Writing Leader

1 mese fa


Siena, Toscana, Italia GlaxoSmithKline A tempo pieno

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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