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 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 Oloveland@planet-pharma.co.uk