Medical Writing Asset Lead

1 month ago


Mississauga, Ontario, Canada GlaxoSmithKline Full time
Job Description

Are you looking for a challenging medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead position could be an ideal opportunity to consider.

As a Medical Writing Asset Lead, you will lead therapy area specific medical writing projects or programs as appropriate in support of the clinical strategy to meet business and regulatory needs, and potentially leading projects across products.

This role will provide you with the opportunity to lead key activities to progress your career, including:

  1. Providing key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents.
  2. Leading matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed.
  3. Planning and successfully implementing large submissions independently or in conjunction with the Medical Writing Director, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary.
  4. Proposing resourcing solutions for major projects, including the number of FTEs required and the best use of internal and external resources.
  5. Effectively organizing content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions.
  6. Actively contributing to the development of training materials for therapeutic area scientists and providing mentoring and/or training on clinical documentation and submission planning to individuals or teams.

Basic Qualifications: We are looking for professionals with the following required skills to achieve our goals:

  • Bachelor's Degree

Preferred Qualifications: If you have the following characteristics, it would be a plus:

  • PhD, PharmD, MPH, MS or other post-graduate degree
  • Possesses highly effective communication skills and is capable of presenting 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.

GSK is an equal opportunity employer committed to diversity and inclusion. GSK is committed to accommodating persons with disabilities. 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. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

Important notice to Employment businesses/Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.



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