Principal Medical Writer - FSP

Parexel; Columbus (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading pharmaceutical company is seeking a Principal Medical Writer for a remote role anywhere in the United States. This role involves writing and overseeing various regulatory documents, ensuring compliance with ICH guidelines. Ideal candidates will have at least 4 years of experience in the pharmaceutical industry, excellent communication skills, and a strong background in regulatory documentation. Join a dynamic team focused on delivering high-quality outputs while meeting submission deadlines.

Qualifications

• At least 4 years of writing experience in the pharmaceutical industry.
• Experience with various regulatory and clinical documents.
• Experience in a matrix team environment.

Responsibilities

• Write and edit clinical regulatory documents for clarity and accuracy.
• Collaborate with lead writers and project teams.
• Ensure compliance with ICH guidelines and Good Clinical Practices.

Skills

Writing experience in the pharmaceutical industry

Regulatory and clinical documents

Knowledge of ICH and CTD guidelines

Communication skills

Problem-solving abilities

Education

BA/BS or higher

Job description

Overview

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 Conference 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.

Responsibilities

• 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

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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.