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Job Details

Senior Regulatory Medical Writer

Company: PAREXEL
Location: Uxbridge, England,United Kingdom
Reference: 38196BR
Closing Date: 22 Mar 18
Type: Not Specified
Salary (£): Competitive

Job Summary:

This position is open for applicants from UK and Spain. ...


This position is open for applicants from UK and Spain.

Key Accountabilities

  • Write clinical documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
  • Serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
  • Serve as the Medical Writing representative on assigned project teams.
  • Providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
  • Coordinate production and distribution of draft and final documents to project team and client.
QualificationsClinical research/medical writing experience:
  • Experience in writing multiple clinical study reports, and either CTD documents or study protocols.
  • Preferably experience in a variety of indications, particularly CNS (schizophrenia, depression, Alzheimer’s), renal disease, oncology, dermatology.
  • Experience with a variety of documents (CSRs, IBs, protocol/amendments, briefing books, HA responses, post-submission safety updates, and preferably submissions [clinical CTD modules].
  • Excellent interpersonal, verbal and written communication skills.
  • Client focused approach to work.
  • A flexible attitude with respect to work assignments and new learning.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Willingness to work in a matrix environment and to value the importance of teamwork.
  • Team leadership skills.
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
  • Extensive clinical/scientific writing skills.
  • Educated to degree level in Life Sciences/Health Related Sciences or equivalent.
  • Fluency in English (written and spoken) is required.

Apply for this job: Senior Regulatory Medical Writer

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site

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