Are you a time served Senior Medial Writer with experience authoring Clinical Regulatory documents such as Study Protocols, Clinical Study Reports and Investigators Brochures?
GMP Recruitment are proud to be partnered with a hugely successful company that provides expert medical writing services to support all stages of a product’s life cycle.
We are currently supporting their recruitment for a Senior Medical Writer to join their team on a full time, permanent contract, working from their office located in based in Crowthorne, Berkshire. The successful candidate will have experience in authoring Clinical Regulatory documents such as Study Protocols, Clinical Study Reports and Investigators Brochures.
To be considered for this role you must demonstrate 4 or more years of Medical Writing experience, authoring Clinical Regulatory documents (not compiling or project managing but authoring)
This position is a mix of office-based and home-based work - employees are office-based Mondays, Tuesdays and Thursdays with Wednesdays and Fridays being work from home days. Our client being based in Crowthorne means you will need to be in a commutable distance to the office or be willing to relocate.
For extremely experienced writers who live far away, we would consider hybrid working with 1 working day a month in the office. Salary up to £55K which is dependent on experience.
As a Senior Medical Writer, you will be responsible for the preparation and QC of all types of safety and regulatory documents, functioning as the lead Medical Writer and liaising with clients to ensure timely delivery of projects. A Senior Medical Writer is also responsible for the mentoring and training of other Medical Writers and supporting the Managing Director with business development activities.

Senior Medical Writer main duties:

• Prepare all types of safety, clinical and regulatory documents in accordance with the relevant SOPs and templates in all regions.
• Perform QC of all types of safety, clinical and regulatory documents in accordance with the relevant SOPs and QC checklists.
• Function as the medical writing lead on a variety of projects.
• Work closely with the client’s team to develop appropriate project plans.
• Mentor more junior team members in their medical writing activities and in their development to become a Medical Writing Lead.
• Ensure adherence to the agreed timelines for each assigned project.
• Provide project status updates on a regular basis.
• Perform monthly review of guidelines and regulations and communicates outcomes to rest of company.
• Keep up with industry development and changes in regulatory guidelines.
• Manages the development and introduction of new report templates, review forms and guidance documents.
• Review of SOPs and update when necessary.
• Participate in the development and delivery of staff training programmes.
• Comply with GCP and GVP principles and applicable regulations/guidelines and train junior team members accordingly.
• Manage and oversee contractor’s work (as allocated by Managing Director).
• Undertake any additional specific duties as allocated by the Managing Director/Line Manager

Senior Medical Writer desired skills and experience:

• Expert understanding of GCP and GVP, plus the ability to assist junior team members in the application to work activities.
• Collate clinical/scientific information.
• Write in a structured way, taking responsibility for multiple documents/projects.
• Able to oversee and mentor staff in the critical appraisal of entire documents by more junior team members to ensure the documents are legible and clear, and meet all relevant guidelines.
• Able to oversee and mentor staff in the critical checking of all data in a report to ensure it is accurate, presented clearly and fully, and is scientifically valid.
• Act as a long-term mentor nurturing new team members for 6 months to a year until they are promoted to Medical Writer or mentoring Medical Writer/Medical Writer 1 in Lead Medical
• Writing role and client project liaison/management.
• Ensures all filing of documentation is performed accurately and in a timely manner on their projects.
• Author SOPs, update SOPs when regulation/guidance change and train other team members on SOPs and their updates

An immediate start can be available for the successful candidate.
If the above position sounds perfect for you, or you require more information, please click apply or contact GMP Recruitment directly.
GMP Recruitment are recruiting for this role on behalf of their client and are acting as an Employment Agency.
Job Types: Full-time, Permanent
Pay: £45,000.00-£55,000.00 per year

Benefits:

• Company car
• Company events
• Company pension
• On-site parking
• Work from home

Schedule:

• Day shift
• Monday to Friday
• No weekends

Education:

• Master’s (required)

Experience:

• Data analysis skills: 4 years (required)
• Clinical research: 4 years (required)
• Analysis skills: 4 years (required)

Work Location: In person
Reference ID: KM103

• Prepare all types of safety, clinical and regulatory documents in accordance with the relevant SOPs and templates in all regions.
• Perform QC of all types of safety, clinical and regulatory documents in accordance with the relevant SOPs and QC checklists.
• Function as the medical writing lead on a variety of projects.
• Work closely with the client’s team to develop appropriate project plans.
• Mentor more junior team members in their medical writing activities and in their development to become a Medical Writing Lead.
• Ensure adherence to the agreed timelines for each assigned project.
• Provide project status updates on a regular basis.
• Perform monthly review of guidelines and regulations and communicates outcomes to rest of company.
• Keep up with industry development and changes in regulatory guidelines.
• Manages the development and introduction of new report templates, review forms and guidance documents.
• Review of SOPs and update when necessary.
• Participate in the development and delivery of staff training programmes.
• Comply with GCP and GVP principles and applicable regulations/guidelines and train junior team members accordingly.
• Manage and oversee contractor’s work (as allocated by Managing Director).
• Undertake any additional specific duties as allocated by the Managing Director/Line Manage