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LifelancerPrincipal Medical Writer - FSP (M/W/D)
Lifelancer is presenting a full-time, remote position for a Principal Medical Writer - FSP (M/W/D) based in London, Greater London, United Kingdom. In this role, the…
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About This Role
Lifelancer is presenting a full-time, remote position for a Principal Medical Writer - FSP (M/W/D) based in London, Greater London, United Kingdom. In this role, the incumbent will create clinical documentation for international regulatory authority submissions and offer strategic guidance to cross-functional project teams with limited supervision. The individual will ensure that materials such as Investigators' Brochures, Clinical Study Reports, and marketing authorization documents clearly present clinical data in alignment…
Job Description
Lifelancer is presenting a full-time, remote position for a Principal Medical Writer - FSP (M/W/D) based in London, Greater London, United Kingdom. In this role, the incumbent will create clinical documentation for international regulatory authority submissions and offer strategic guidance to cross-functional project teams with limited supervision. The individual will ensure that materials such as Investigators' Brochures, Clinical Study Reports, and marketing authorization documents clearly present clinical data in alignment with program goals and regulatory standards. Additionally, the professional will supervise medical writing tasks for various compounds and act as the primary writer for individual summaries. This opportunity suits an experienced writer with broad knowledge of clinical research procedures and global regulatory documentation standards. The employer is IQVIA, a prominent global organization delivering clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare sectors.
Responsibilities
- Develop regulatory documents for global regulatory agencies in adherence to ICH and other international guidelines, client standards, project timelines, and corporate objectives
- Handle medical writing projects by establishing timelines and communicating with cross-functional team members regarding review cycles and expectations
- Attend cross-functional meetings to offer input on medical writing deliverables, timelines, and regulatory document completion processes
- Review related project documents including protocols and statistical analysis plans
- Take part in cross-functional process improvement initiatives
- Contribute to defining and writing standard operating procedures and best practices for preparing quality documents efficiently
- Supervise internal and contract medical writing resources to guarantee timely project completion
Requirements
- At least five years of medical writing experience within the biopharmaceutical or contract research organization industry, or comparable experience in clinical or preclinical development
- Proficiency in organizing and communicating clinical information independently with minimal oversight
- Strong organizational, time management, and project management capabilities
- Solid verbal, written, and interpersonal communication skills for teamwork
- Proficient understanding and knowledge of global regulatory requirements
Qualifications
- Bachelor degree
- Advanced degree in a relevant scientific, clinical, or regulatory field
- Desirable knowledge of therapeutic areas across all phases of clinical development
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the job location type is designated as remote, situated in London, Greater London, United Kingdom.
What is the employment type?
The position is a full-time contract.
What education is required for this role?
A Bachelor degree is required, while an advanced degree in a relevant scientific, clinical, or regulatory field is preferred.
How can I apply for this position?
Candidates are instructed to apply via the Lifelancer platform to connect with the application page.
What is the salary for this position?
The posting does not specify the salary.
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