Senior Manager, Medical Writing
2 months ago
Job Title: Senior Manager, Medical Writing – Regulatory Affairs
Job Type: Permanent, full-time
Location: Central London, UK – 4x a week in London
Remuneration: Up to £80,000 + Benefits
An exciting and rare opportunity for an experienced Medical Writer to join a growing clinical research organisation, which are at the forefront of bringing innovation to patients globally.
Provides a senior level of expertise and management for the medical writing team. Responsible for the fulfillment of medical writing and regulatory activities, ensuring optimal allocation of medical writing and regulatory resources.
Job responsibilities:
- Direct line management responsibilities for the Medical Writing team. This will involve: Allocation of study related tasks, Supervision of progress of tasks completion, Training of medical writing team and Feedback and appraisal for medical writing team members.
- Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
- Confident with the development of the following documents, including, but not limited to: clinical trial outlines, clinical trial protocols/amendments, Clinical/Non-clinical 2.4, 2.5, 2.6, 2.7 CTD modules, investigators brochures, PIPs, DSURs, CSRs, Health Authority briefing books, clinical submission documents, and other clinical documentation to support the conduct of the clinical trials and regulatory submissions/filings.
- Oversee the preparation, and submission, of all study documentation in accordance with regulatory requirements.
- Serve as a document or process subject matter expert, leading cross-functional and cross-department process improvement initiatives.
- Supporting medical writing activities across all stages of drug development.
- Planning and authoring stages across all document types and regulatory submissions, including facilitating document contributor/review meetings, developing and managing timelines, coordinating document review, and driving decision-making.
- Initiate and drive strategic medical writing initiatives and processes with high technical acumen to ensure execution on company priorities.
- Proactively lead and/or engage in department activities and serve as a mentor for junior writers.
- Actively provide input to the overall strategy, unified objectives, and areas for development of the Medical Writing department.
Job Requirements:
- At minimum a degree in life sciences and at least 6 years’ medical or regulatory/clinical writing experience, in the pharmaceutical/ CRO industry.
- Expert understanding and knowledge of regulatory requirements and drug development processes, regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports), CTA/IND/HA regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
- Confident in people management and leadership.
- You are capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.
- You are motivated and detail-oriented.
- You have the ability to work across all trial phases and prioritise your own tasks.
- You are proactive and open-minded.
This is a perfect opportunity for a Senior/Principal Medical Writer to step in and take the lead on all medical writing activities.
For more information about this position please reach out to lucy.kirkaldy@cpl.com
Please note you MUST have the right to work in the UK without any restrictions.
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