Director of Clinical Content Operations

2 days ago


Mississauga, Ontario, Canada GlaxoSmithKline Full time

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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