Parexel Uxbridge, England, United Kingdom
Senior Medical Writer
Parexel Uxbridge, England, United Kingdom
3 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
We are looking for a Senior Medical Writer to join our expanding team. These roles can be fully home-based in various European countries.
As a Senior Medical Writer, you will research, create, and edit all documents associated with clinical research. You will operate as the project lead writer/submission coordinator and primary client contact, managing contributions from multiple writers. You will also facilitate process improvement, provide technical mentoring/training, and support Medical Writing Services management during the sales process by liaising with clients and contributing to proposals.
Key Responsibilities
1. Author Clinical Documents: Prepare, develop, and finalize clinical documents for regulatory submission, including briefing documents, investigator brochures, study protocols, informed consents, clinical study reports, CTD summaries, safety reports, and integrated safety and efficacy summaries.
2. Quality Control: Ensure all work is complete and of high quality before distribution. Review drafts prepared by other writers for accuracy, content, and editing.
3. Project Management: Lead projects, manage scope, timelines, and goals. Develop work plans and delegate tasks to team members.
4. Client Liaison/Service: Maintain awareness of client expectations, respond to dissatisfaction, and support business development efforts, including client meetings and sales presentations.
5. Training/Compliance: Stay updated on advances in medical writing and regulations. Develop staff skills and ensure departmental SOP compliance.
6. General: Attend meetings, analyze work efficiency, and suggest improvements.
Qualifications and Skills
* Bachelor's degree in Life Sciences or Health-Related Sciences or equivalent.
* Excellent communication, negotiation, and interpersonal skills.
* Adaptability, motivation, organizational skills, and ability to work in a fast-paced environment.
* Team leadership, cross-cultural sensitivity, and sound judgment.
* Understanding of clinical research, drug development, and industry guidelines (e.g., ICH-GCP).
* Extensive clinical/scientific writing experience, including study reports, protocols, or CTD documents.
* Proficiency in MS Office, document management systems, and collaborative tools.
* Fluent in English, with excellent grammar and punctuation skills.
We offer a structured career pathway, competitive salary, bonus, and benefits, including holiday, pension, and other perks. Apply today to start your journey with Parexel!
#J-18808-Ljbffr