Senior/ Medical Writer

Description

You will be a full-time (FTE) medical writer working as an integrated member of the team, producing clinical documents such as Clinical Trial Reports (CTRs), Trial Design Outlines and Clinical Trial Protocols (TDOs/CTPs) with their amendments, Briefing Books, Investigator's Brochures (IBs) with updates, Biomarker Reports, and submission documents like the Summary of Clinical Efficacy and Safety.

The work focuses on eye health and inflammation. Senior experience in these therapeutic areas is preferred.

The role is dedicated to one sponsor and embeds you in its processes and workflows, including Feedback and Alignment Meetings. You will join project planning, discussions and all required training, and use the sponsor's systems, tools and methods so you work smoothly with internal teams.

The company provides clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

Responsibilities

• Draft documents with in-text tables and figures to the timelines agreed with the trial or project team.
• Set up and manage clinical documents in the Electronic Document Management System (EDMS), and review and approve the Statistical Analysis Plan there.
• Propose timelines to the trial team based on the sponsor's dates, finalise them once agreed, and update them as needed.
• Prepare for and attend required trial team and submission meetings.
• Prepare, run and record kick-off meetings for TDO/CTP, IB and CTR writing.
• Prepare, run and record Results Alignment Meetings (RAM), which do not apply to Phase I healthy volunteer studies.
• Send drafts, manage every review cycle, reach agreement on comments, integrate changes into the text, and complete the Review Documentation Form where applicable.
• Start or carry out Quality Control (QC) checks and complete the Quality Control Documentation Form (QCDF).
• Create the final document version and deliver it to the trial or project team.
• Start publishing and pre-archive checks, then monitor and resolve any findings.
• Give e-approval to final clinical documents in the EDMS.
• Run technical checks on final drafts of initial IBs and IB updates in the EDMS, using the Final Formatting checklist.
• Follow the correct process for each document type and the sponsor's SOPs.

Requirements

• A bachelor's degree in a scientific, clinical, regulatory or related field is required.
• An advanced degree such as an MSc, PhD, PharmD or MD is preferred.
• About 5 years of medical writing in the biopharmaceutical, biotechnology or CRO industry. Equivalent experience in clinical or preclinical development is also considered.
• Solid understanding of global regulatory requirements and guidelines such as ICH, FDA and EMA across all clinical development phases.
• Broad knowledge of clinical research, including study design, data analysis and regulatory submission requirements.
• Proven ability to lead writing on complex documents and give strategic input to cross-functional teams.
• Clear, accurate written and spoken communication of complex scientific and clinical information.
• Strong organisation, time management and project management skills, with the ability to juggle several priorities and meet tight deadlines.
• Ability to work well in a collaborative, cross-functional team and to work independently when needed.
• Close attention to detail, with a focus on quality, consistency and scientific accuracy.
• Proficiency in Microsoft Word and good document formatting practice.
• Experience with electronic document management systems (eDMS), document templates, style guides and structured authoring tools.

Conditions

Candidates must make sure all information and credentials in their application are truthful and complete, as false statements or omissions can lead to disqualification or later dismissal under applicable law.