Senior Medical Writer FSP (MWD)

The FTE Medical Writer willserve as an integratedmember ofthe team deliveringmedical writing services for thedevelopment of clinical documents including Clinical Trial Reports (CTRs) Trial Design Outlines/Clinical Trial Protocols (TDOs/CTPs) and CTP amendments Briefing BooksInvestigators Brochures (IBs) and IB updates Biomarker Reportsandsubmission documentssuch as theSummary of Clinical Efficacy and Safety etc. Emphasis will beplacedon the therapeutic areasofeye health and inflammation; senior-level experience in these areas is preferred.

The FTE Medical Writer will work on a dedicated basis and be embeddedin sponsors processes and workflows including Feedback and Alignment this role the FTE Medical Writer willparticipate in ongoing project-related activities such as planning project discussions and all required training sessions. The FTE Medical Writer willadopt sponsors 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 meetingsor 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)

• Initiation and monitoring or conducting of Quality Control (QC) checks as well as completion of the Quality Control Documentation Form (QCDF)

• Creation and provision of the final document version to the trial/project team

• Initiation of publishing and pre-archive checks monitoring and resolution of findings

• E-approval of final clinical document in the EDMS

• Technical checks after the final draft of initial IBs and IB updates in the EDMS and by going through a Final Formatting checklist document

• FTE Medical Writer will follow the appropriate process as per document type and according to sponsor SOPs

Qualifications

• Bachelors 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

• Proficiency in Microsoft Word and document formatting best practices

• Experience with electronic document management systems (eDMS) and familiarity with document templates style guides and structured authoring tools

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