Medical Writing Asset Lead
1 month ago
We are seeking a highly skilled Medical Writing Asset Lead to join our team in the Oncology department. As a key member of our clinical writing team, you will be responsible for leading therapy area specific medical writing projects or programs to support our clinical strategy and meet business and regulatory needs.
Key Responsibilities:
- Contribute to the development of clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents.
- Lead matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed.
- Plan and implement large submissions independently or in conjunction with the Medical Writing Director, recommending methods or innovative solutions for achieving accelerated timelines as necessary.
- Propose resourcing solutions for major projects, including number of FTEs required and best use of internal and external resources.
- Act as lead author on submissions and effectively organize content and arguments in complex clinical submission documents.
- Contribute to the development of training materials for therapeutic area scientists and provide mentoring and/or training on clinical documentation and submission planning to individuals or teams.
Requirements:
- Bachelor's Degree
- PhD, PharmD, MPH, MS or other post-graduate degree (preferred)
- Highly effective communication skills and ability 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.
About GSK:
GSK is 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. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
We are committed to accommodating persons with disabilities and welcome applications from all qualified individuals. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.
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