Medical Writer

Planet Pharma; United Kingdom; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading global organization in life sciences is seeking an experienced Medical Writing Project Lead. The role involves managing the creation of clinical documents and collaborating across teams, offering an excellent opportunity for professional growth in a highly regulated environment.

Qualifications

• Minimum 3 years’ medical writing experience, including 1 year in project lead.
• Solid understanding of clinical research and regulatory standards.
• Proactive approach with excellent time management.

Responsibilities

• Create clinical documents including study protocols and CSRs.
• Lead project discussions and manage document development timelines.
• Ensure compliance with regulatory guidelines.

Skills

Medical Writing

Project Management

Communication

Data Interpretation

Stakeholder Engagement

Regulatory Compliance

Job description

Direct message the job poster from Planet Pharma

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 experienced Medical Writing Project Lead to 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 [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Research, and Project Management

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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