Parexel
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.
Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives.
Provide writing support for a wide range of documents, including but not limited to investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.
Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices.
Collaborative relationships
Collaborates effectively with lead writers and project teams to develop 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
BA/BS or higher
#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.
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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.
Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives.
Provide writing support for a wide range of documents, including but not limited to investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.
Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices.
Collaborative relationships
Collaborates effectively with lead writers and project teams to develop 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
BA/BS or higher
#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.
#J-18808-Ljbffr