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Senior Medical Writer

2+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Medical Writer
Location: Remote – United Kingdom, Italy, Poland, South Africa (Bloemfontein), Spain
Company: Parexel

Position Overview:
Parexel is hiring a Senior Medical Writer to support the development of clinical documents for regulatory authorities and diverse stakeholders. This remote position is available across multiple European and international locations. You will serve as the lead writer and primary client contact on projects, with opportunities to mentor junior writers and contribute to process improvement and business development.

Key Responsibilities:

Clinical Document Authoring:

  • Draft and finalize clinical documentation including protocols, investigator brochures, informed consents, clinical study reports, CTD modules, safety updates, and briefing documents.

  • Incorporate cross-functional input and regulatory feedback efficiently.

Quality Control:

  • Review and edit documents for clarity, consistency, grammar, and regulatory compliance.

  • Provide editorial feedback on documents created by peers.

Project Management:

  • Act as lead writer and manage project scope, timelines, and deliverables.

  • Coordinate contributions across writing teams and ensure timely delivery.

Client Liaison & Business Development:

  • Communicate with clients and address any dissatisfaction promptly.

  • Support sales activities and represent Medical Writing Services in business development efforts.

Training & Compliance:

  • Mentor team members and assist in skill development.

  • Ensure SOP compliance and support SOP updates as needed.

General Duties:

  • Participate in team meetings and track project progress using designated platforms.

  • Suggest process improvements and contribute to operational efficiency.

Required Qualifications:

  • Bachelor’s degree in Life Sciences or Health Sciences.

  • Demonstrated experience in clinical/scientific writing (study protocols, CTD, study reports).

  • Fluent written and verbal English; expert in MS Word and familiar with document management systems.

Skills & Experience:

  • Strong communication and negotiation abilities.

  • Ability to manage multiple projects, prioritize, and maintain quality under pressure.

  • Experience working in a matrix team and across cultures.

  • Proven knowledge of regulatory guidelines (e.g., ICH-GCP).

  • Leadership capabilities and client relationship management.

What Parexel Offers:

  • Competitive salary and performance-based bonus.

  • Career development with mentorship and rotation opportunities.

  • Comprehensive benefits including pension, holidays, and more.

  • An inclusive and supportive work environment focused on patient impact.

Apply today and join Parexel’s mission to improve global health.