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Job Details

Senior Medical Writer (Remote)
  • Job ID: 129308
  • Employment Type: Full Time
  • Country: United Kingdom
  • State/Province: England
  • City: Farnborough
  • Zip/Postal Code: GU14 7BF
  • Job Category: Operational Services
  • Internal Job Description:
  • Travel Percentage:
  • Project Start Date:
  • Project End Date:
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Overview

Do you want to work in an environment and culture where you can thrive, develop and advance?

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

An opportunity has arisen for a Senior Medical Writer to author, edit and peer review medical writing documents supporting the analysis, reporting and publication of clinical data and information. The role can be home based.

Responsibilities

  • Independently author or lead authoring, including editing of documents such as:
    • Clinical study documents or documents for regulatory submission e.g., protocols, clinical study reports, patient narratives, investigator brochures
    • External scientific communications e.g., manuscripts, abstracts, standard response documents, FAQs, response to authorities
    • Results summaries to support clinical trial disclosure commitments
  • May independently author or lead authoring complex documents such as INDs, clinical summaries and overviews, briefing documents, response to authorities and PIPs.
  • Participate in and potentially lead meetings with clients as required to understand expectation, establish trust and confidence with client counterparts.
  • Provide quality assurance and training, and may provide technical mentoring of team members.
  • Support work allocation and provide oversight to team members in execution of their project responsibilities.
  • As a Subject Matter Expert, may provide internal advice on Development Operations services based on expertise to support business development and training.
  • Systematically review or perform quality control checks of documents prepared by junior colleagues against pre‑specified check‑lists and follow‑up independently until final submission, or as assigned.

Job Requirements

  • Degree, or advanced level degree in a life science discipline.
  • Experience and technical skills within Medical Writing or Medical Information, as a part of a pharmaceutical company or CRO.
  • Experience of authoring protocols, clinical study reports, patient narratives, investigator brochures.
  • Significant knowledge of regulatory requirements or guidance pertaining to medical writing or medical Information.
  • Strong knowledge of basic computer applications, e.g. MS Word/PowerPoint/Excel.
  • Excellent verbal and written communication skills.

 If you want to be part of a progressive, forward-thinking company and want to make a difference then we want to hear from you.

We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion