Senior/ Medical Writer - FSP (M/W/D)
Added 20 Aug · still live
Not disclosed
Salary
Not disclosed by employer
£41,700
Going rate
Skilled Worker going rate
This role likely qualifies for a Skilled Worker visa
SOC 3412 (85% match) is an eligible occupation, with a going rate of £41,700, and IQVIA is a licensed sponsor. That is our reading of the rules. Whether they issue a Certificate of Sponsorship is still their call.
About the role
The FTE Medical Writer will serve as an integrated member of the team, delivering medical writing services for the development of clinical documents, including Clinical Trial Reports (CTRs), Trial Design Outlines/Clinical Trial Protocols (TDOs/CTPs) and CTP amendments, Briefing Books, Investigator’s Brochures (IBs) and IB updates, Biomarker Reports, and submission documents such as the Summary of Clinical Efficacy and Safety, etc. Emphasis will be placed on the therapeutic areas of eye health and inflammation; senior-level experience in these areas is preferred.
The FTE Medical Writer will work on a dedicated basis and be embedded in sponsor’s processes and workflows, including Feedback and Alignment Meetings. In this role, the FTE Medical Writer will participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions. The FTE Medical Writer will adopt sponsor’s systems, tools, and methodologies to ensure seamless collaboration and alignment with internal teams.
Tasks Typically Include, But Are Not Limited To
The FTE Medical Writer will work on a dedicated basis and be embedded in sponsor’s processes and workflows, including Feedback and Alignment Meetings. In this role, the FTE Medical Writer will participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions. The FTE Medical Writer will adopt sponsor’s systems, tools, and methodologies to ensure seamless collaboration and alignment with internal teams.
Tasks Typically Include, But Are Not Limited To
- Document management: Set-up and management of clinical document in the Electronic Document Management System (EDMS)
- Review and approval of the Statistical Analysis Plan in the EDMS
- Management of timelines including proposal of timelines to trial/project team (based on timelines communicated by sponsor), finalising them after agreement, and updating them as appropriate
- Preparation for and attendance of the required trial team meetings or submission meetings
- Preparation, conduct, and documentation of kick-off meetings, e.g. for TDO/CTP, IB or CTR writing
- Preparation, conduct, and documentation of Results Alignment Meetings (RAM; not applicable for Phase I in healthy volunteer studies)
- Writing of drafts including appropriate in-text tables and figures according to the timelines agreed upon with trial/project team
- Provision of drafts and management of all review cycles by the trial/project team, reaching consensus on comments/changes, integration of changes into the text, and completion of the Review Documentation Form (as applicable)
- Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
- Approx 5 years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
- Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
- Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
- Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
- Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
- Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
- Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
- High attention to detail with a commitment to quality, consistency, and scientific accuracy
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
This description is the source posting as it read when we added it. We are not affiliated with IQVIA, so check their own site for the current details.
Where this offer sits in the market
SOC 3412 · UK · ONS ASHE 2025 · ~19k in sampleP25 £33kP75 £46k
£29kmedian £38kgoing rate £42k£46k
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About sponsorship for this role
Does this job guarantee visa sponsorship?
Not necessarily. IQVIA holds a sponsor licence, but sponsorship for a specific hire is always the employer's decision. Be upfront in your application that you'll require it.
What salary is needed for this role to be eligible?
The offer must clear both the general threshold and the SOC 3412 going rate of £41,700. New-entrant and shortage discounts can lower it.