Medical Writer

Job Purpose

We are seeking a highly qualified and experienced Medical Writer to join our R&D Operations team.

This is a crucial opportunity to contribute to the preparation, editing, and compilation of various clinical documents for regulatory submissions across all phases of clinical drug development and post-marketing studies.

The Medical Writer will support the Senior Medical Writing Manager, ensuring all documentation is clear, concise, scientifically accurate, and compliant with current regulations, thereby contributing to the successful progression of our drug development initiatives

Key Responsibilities

• Support the Senior Medical Writing Manager in the preparation, editing and compilation of various clinical documents for regulatory submission during all phases of clinical drug development and post‐marketing studies.
• Independently prepare clinical study documentation, including Patient Safety Narratives, Patient Lay Summaries, patient consent forms, dossier related documentation (such as Clinical summaries, Briefing Books, PDCO submissions), with support from other functions.
• Support the senior MW manager in the preparation of Clinical Study Protocol and Reports and IB across various therapeutic areas.
• Perform the quality control (QC) review of clinical study documentation when requested.
• Tabulate clinical studies results.
• Perform on-line clinical literature search, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines. Ensure controlled and accurate use of medical and scientific terminology.
• Support in redaction of clinical documents in accordance with EU Clinical Trial Regulation, EMA Policy 0070 and other global regulations.
• Support the redaction of the Standard Operating Procedures.
• Responsible for the compilation and publication of trial data in relevant registries with support from the relevant Medical Director.
• Participation in cross‐functional global team meetings.
• Collaborate with Clinical Study Managers, Project Leaders, Clinical trial Application Manager, Regulatory development lead, Biostatistics, Patent and Legal, to ensure awareness of data sharing requests and proper safeguarding of the data in collaboration with the company DPO, where applicable.
• Collaborate with Clinical Operations, Global Project Teams, and other stakeholders to operationalize and develop novel processes related to redaction requirements.
• Interact with Project Teams irrespective of global location.
• Work closely with Clinical Operation and Development Teams, for both SPC & Rare Diseases BUs, Medical Affairs, Regulatory Affairs, Quality Assurance, Portfolio Management and other functions, as appropriate.

Required Education

Minimum of a bachelor’s degree in a relevant scientific field (e.g., Life Science, Pharmacy). An advanced degree (Master’s, PhD., or equivalent) is preferred.

Required Skills and Experience

• 5+ years’ experience as a Medical Writer in the CRO/pharmaceutical industry.
• Strong portfolio demonstrating a track record of creating clear, concise, and scientifically accurate documents, such as clinical study reports, regulatory submissions, and scientific publications.
• Familiarity with various therapeutic areas and drug development processes.
• Excellent writing and editing skills, with a keen eye for details and the ability to interpret complex scientific and clinical data and present it clearly. Proficient in creating a variety of documents (clinical protocols, clinical reports, investigator brochures, and regulatory documents).
• Regulatory knowledge: Understanding of regulatory guidelines and requirements related to clinical research and drug development (e.g., ICH guidelines).
• Experience with preparing documents for regulatory submissions (e.g., INDs, NDAs, MAAs) is highly desirable.

Technical Competencies

Proficient in using relevant software and tools for document preparation and collaboration (e.g., Microsoft Office, document management systems like Veeva).

Required Behaviours and Competencies

• Excellent communication skills, both written and verbal, with proven ability to interact effectively within a cross-functional team and with external experts.
• Demonstrated ability to anticipate and resolve problems on projects.
• Proven ability to report project details clearly to various stakeholders within and outside of the company.
• Strong adaptability to evolving project requirements, guidelines, and industry standards.
• Commitment to continuous professional development, to stay updated on the latest developments in scientific research.

Required Languages

Fluent in English