Medical Writer

Planet Pharma
Cambridge
5 days ago
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Medical Writing Project Lead

Location:Remote, UK

Contract Type:12 month contract

Industry:Pharmaceutical / Clinical Research


Experience Required:Minimum 3 years in Medical Writing, including at least 1 year as a project lead


Overview:

Our client, a leading global organization in the life sciences sector, is seeking an experiencedMedical Writing Project Leadto support the development of clinical documentation across various study phases, with a focus on Phases I–III protocols and clinical study reports (CSRs). This role offers the opportunity to lead study-level writing tasks and collaborate cross-functionally in a dynamic, highly regulated environment.


Key Responsibilities:

  • Independently create a range of clinical documents, including study protocols, informed consent forms (ICFs), clinical study reports (CSRs), layperson summaries, briefing materials, and Investigator Brochures.
  • Assist senior medical writers with the preparation of complex or high-level submission documents.
  • Analyze and interpret clinical data to produce clear, accurate, and scientifically sound content.
  • Lead discussions around document development, ensuring strategic alignment and effective stakeholder input.
  • Coordinate and facilitate meetings to drive decisions and advance medical writing deliverables.
  • Uphold high standards of quality, accuracy, and compliance with both regulatory guidelines and internal procedures.
  • Act as a representative for the medical writing function in cross-functional project meetings.
  • Oversee timelines, manage stakeholder feedback, and guide documents through review and finalization.
  • Adhere to internal SOPs and client-specific processes throughout the document development lifecycle.
  • Support process enhancements and contribute to collaborative knowledge sharing across teams.


Required Skills & Experience:

  • A minimum of 3 years’ medical writing experience within the pharmaceutical or CRO sector, including at least 1 year in a project leadership role.
  • Solid understanding of clinical research processes, regulatory requirements, and documentation standards.
  • Proven track record of independently managing medical writing projects from start to finish.
  • Strong interpersonal and communication skills, with the ability to effectively engage stakeholders at all levels.
  • Self-motivated and resourceful, with a proactive and problem-solving approach to challenges.
  • Capable of guiding content discussions, aligning teams, and facilitating decisions.
  • Highly organized, with excellent time management and the ability to juggle multiple projects simultaneously.
  • Comfortable interpreting complex data sets and presenting them in clear, regulatory-compliant formats.
  • Experienced in navigating SOPs, templates, and regulatory frameworks in a structured work environment.



This is an excellent opportunity for a motivated medical writer to lead impactful projects and contribute to global clinical programs.


For more information or to apply, please contact Ollie at Planet Pharma at

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