Senior Medical Writer – Regulatory Docs Lead (Remote)

Parexel; Frankfort (KY); Remote; USD 90,000 - 140,000; Full time

Job summary

Parexel is seeking an experienced Medical Writer to author and finalize clinical documents for regulatory submissions. You will review drafts, ensure SOP/compliance adherence, and support project teams across client projects.

Required are strong clinical writing skills, English fluency, and experience with CTD-style documents. The role may involve leadership of authoring teams and mentoring junior writers in a dynamic, regulated environment.

Qualifications

• Extensive clinical/scientific writing skills.
• Experience writing study reports, protocols, CTD documents or similar.
• Fluent in written and spoken English with proper grammar.
• Proficiency with MS Word and collaboration tools (SharePoint).
• Experience in translation work and quality control may be required.
• Understanding of ICH-GCP guidelines.

Responsibilities

• Act as medical writing project lead, coordinating timelines and deliverables.
• Coordinate interdepartmental reviews and client communications.
• Mentor/train staff and ensure quality control of documents.
• Ensure adherence to regulatory guidelines and SOPs during document development.
• Develop and manage project documentation and collaboration workflows.

Skills

Interpersonal skills

High-quality writing

Attention to detail

Project planning

Adaptability

Time management

Team leadership

Client negotiation

Client relationship

Cross-cultural sensitivity

Education

Bachelor's degree in Life Sciences/Health Related Sciences

Tools

MS Word

SharePoint

Document management systems

Job description

Parexel is seeking an experienced Medical Writer to author and finalize clinical documents for regulatory submissions. You will review drafts, ensure SOP/compliance adherence, and support project teams across client projects.

Required are strong clinical writing skills, English fluency, and experience with CTD-style documents. The role may involve leadership of authoring teams and mentoring junior writers in a dynamic, regulated environment.