Senior/ Medical Writer - FSP (M/W/D)

Description

You will join the team as a full-time medical writer, working on a dedicated basis and embedded in the sponsor's processes, including feedback and alignment meetings.

You will write clinical documents such as clinical trial reports, trial design outlines and clinical trial protocols with amendments, briefing books, investigator's brochures with updates, biomarker reports, and summaries of clinical efficacy and safety for submissions. The focus is on eye health and inflammation, where senior experience is preferred.

You will take part in 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 is a global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

Responsibilities

• 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 dates the sponsor gives, agree them, and update them as needed.
• Prepare for and attend required trial team or submission meetings.
• Plan, run and record kick-off meetings for protocols, investigator's brochures and clinical trial reports.
• Plan, run and record results alignment meetings, except for phase I studies in healthy volunteers.
• Write drafts with in-text tables and figures to the agreed timelines.
• Send drafts, manage every review cycle, agree on comments, build changes into the text, and complete the review documentation form where it applies.
• Run or oversee quality control checks and complete the quality control documentation form.
• Prepare and deliver the final document version to the trial team.
• Start publishing and pre-archive checks, then track and resolve any findings.
• E-approve the final clinical document in the EDMS.
• For initial investigator's brochures and updates, run technical checks in the EDMS and work through the final formatting checklist.
• Follow the correct process for each document type under the sponsor's SOPs.

Requirements

• Bachelor's degree in a scientific, clinical, regulatory or related field.
• About 5 years of medical writing in the biopharmaceutical, biotechnology or CRO industry. Equivalent experience in clinical or preclinical development is also considered.
• Solid knowledge of global regulatory requirements and guidelines such as ICH, FDA and EMA across all phases of clinical development.
• Broad understanding of clinical research, including study design, data analysis and regulatory submission requirements.
• Proven record of leading writing on complex documents and giving strategic input to cross-functional teams.
• Clear, accurate written and verbal communication of complex scientific and clinical information.
• Strong organisation, time management and project management skills, with the ability to handle several priorities and tight deadlines.
• Works well in a collaborative, cross-functional team and independently when needed.
• High attention to detail, with a commitment to quality, consistency and scientific accuracy.
• Proficiency in Microsoft Word and document formatting best practice.
• Experience with eDMS, document templates, style guides and structured authoring tools.
• Advanced degree such as MSc, PhD, PharmD or MD is preferred.
• Senior-level experience in eye health and inflammation is preferred.

Conditions

Full-time (FTE) role on a dedicated basis, embedded with the sponsor.

All application information must be truthful and complete; false statements or material omissions can lead to disqualification or later termination, in line with applicable law.