Principal Medical Writer- FSP

Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.

Job Purpose

The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and / or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality.

This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company's objectives.

Key Accountabilities

Oversight of activities

• Write and edit clinical regulatory documents for clarity, and accuracy

according to Sponsor standards.

and data presentations within submission timelines to meet company objectives.

limited to investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.

Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices.

Collaborative relationships

and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines.

Compliance with Parexel standards

Complies with required training curriculum

Completes timesheets accurately as required

Submits expense reports as required

Updates CV as required

Maintains a working knowledge of and complies with Parexel processes,

ICH-GCPs and other applicable requirements

Skills

At least 4 years of writing experience in the pharmaceutical industry

Experience with a variety of regulatory and clinical documents

Experience in a matrix team environment

Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents

Knowledge and Experience

Ability to write and edit complex material to ensure accuracy and clarity,

Excellent written and oral communication skills and demonstrated problem-solving abilities

Ability to handle multiple projects and short timelines

Ability to work cooperatively with colleagues in a wide range of disciplines

Education

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.