Associate Director, Data Management Leader

3 weeks ago


Mississauga, Ontario, Canada GlaxoSmithKline Full time
Job Title: Associate Director, Data Management Leader

Are you a seasoned professional with a passion for medical writing and data management? Do you have a strong background in clinical pharmacology and regulatory affairs? We are seeking an experienced Associate Director to lead our medical writing team and drive the development of high-quality clinical documents.

Key Responsibilities:
  • Develop and implement medical writing strategies to support the development of clinical programs and content of documents.
  • Lead a matrix team to deliver high-quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with GSK standards and global/regional/local regulatory requirements.
  • Collaborate with in-house, CROs, and/or independent contractor medical writers to ensure on-time delivery of high-quality fit-for-purpose documents.
  • Develop and implement process improvements to enhance efficiency, quality, and scientific integrity of writing.
  • Ensure good writing practices and fluid communication within study teams.
Requirements:
  • PhD, PharmD, MPH, MSc, or other post-graduate degree.
  • Proven track record in writing clinical documents in scope.
  • 6+ years' experience in clinical regulatory writing in the pharmaceutical industry.
  • 6+ years' experience in project management, planning, communication, and matrix leadership.
  • 6+ years' experience working with International Council for Harmonization (ICH)/Good Clinical Practice (GCP) Guidelines.
Preferred Qualifications:
  • Experience in immunogenicity, biomarkers, virology.
  • Highly effective communication skills and capability to present ideas and data clearly to a group, including key stakeholders at senior level.
  • Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
  • Experience analyzing complex scientific & operational information and implementing effective solutions.
  • Experience in Risk Management and Management Monitoring.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.



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