Senior​/ Medical Writer - FSP

Frankfurt/Main, Germany | Full time | Hybrid | R1560755

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:

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)

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

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…