Director of Clinical Content Operations
2 days ago
Job Description
The role of Associate Director, Medical Writing Asset Lead, is to lead a team in creating high-quality clinical documents for regulatory submissions. The ideal candidate will have experience in oncology and a proven track record in writing clinical documents.
Responsibilities:
- Develop and implement medical writing strategies for clinical programs and content of documents.
- Lead matrix teams to deliver high-quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with global/regional/local regulatory requirements.
- Collaborate with stakeholders to provide significant contributions to complex clinical submission documents and ensure timely dissemination of information.
- Ensure effective communication, including clear presentation of ideas and data to groups, including key stakeholders at senior levels.
Requirements:
- PhD, PharmD, MPH, MSc, or other post-graduate degree.
- Experience in oncology and clinical regulatory writing in the pharmaceutical industry.
- Proven track record in writing clinical documents in scope and project management, planning, communication, and matrix leadership.
About Us
We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines.
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