Principal Medical Writer - US or Canada - FSP

Parexel; Bismarck (ND); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading healthcare consulting firm is seeking a Principal Medical Writer in Bismarck, North Dakota. This role involves writing and overseeing clinical regulatory documents, ensuring compliance with guidelines and quality standards. Candidates should have at least 15 years of experience in medical writing, possess excellent communication skills, and the ability to manage multiple projects. Join a collaborative team to contribute to impactful healthcare solutions.

Qualifications

• At least 15 years of medical writing experience in the pharmaceutical industry.
• Ability to write and edit complex material for accuracy and clarity.
• Experience with various regulatory and clinical documents.

Responsibilities

• Write and edit clinical regulatory documents for clarity and accuracy.
• Develop document messages and data presentations within timelines.
• Ensure compliance with International Conference on Harmonization guidelines.

Skills

Medical writing experience

Document editing

Communication skills

Education

BA/BS

Advanced degree

Job description

Overview

The Principal Medical Writer 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, 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

• Write and edit clinical regulatory documents for clarity and accuracy according to client 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, SOPs, and Good Clinical Practices.

Requirements

• At least 15 years of medical writing experience in the pharmaceutical industry
• Ability to write and edit complex material to ensure accuracy and clarity
• Experience with a variety of regulatory and clinical documents
• Experience in a matrix team environment
• 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
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents

Education

• BA/BS, Advanced degree preferred

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.