Associate Director, Data Management Leader
3 weeks ago
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.
- 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.
- 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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Associate Director, Data Management Leader
2 weeks ago
Mississauga, Ontario, Canada GlaxoSmithKline Full timeJob Title: Associate Director, Data Management LeaderAre you a seasoned professional looking for a challenging role that leverages your expertise in medical writing and data management? We are seeking an Associate Director, Data Management Leader to join our team at GlaxoSmithKline.About the Role:This is a highly visible medical writing role that requires a...
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Associate Director, Data Management Leader
3 weeks ago
Mississauga, Ontario, Canada GlaxoSmithKline Full timeJob Title: Associate Director, Data Management LeaderAre you a seasoned professional looking for a challenging role that leverages your expertise in medical writing and data management? We are seeking an Associate Director, Data Management Leader to join our team at GlaxoSmithKline.About the Role:This is a highly visible medical writing role that requires a...
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Mississauga, Ontario, Canada GlaxoSmithKline Full timeJob Title: Associate Director, Data Management LeaderGlaxoSmithKline is seeking a highly skilled and experienced Associate Director, Data Management Leader to join our team. As a key member of our Clinical Publishing department, you will be responsible for providing leadership and strategic direction to ensure the successful delivery of clinical publishing...
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