Job description

The Medical Writer will support the clinical team by providing a thorough and deep understanding of the client’s demands with regards to research question, objectives and outcomes. She/he will provide educated guesses, advice and feedback with regards to clinical studies designs and methodologies. The Medical Writer will be brought to produce clinical protocols, build study designs along with the statistical team, proceed to literature reviews, write investigator brochures and research proposals, to only name these. She/he will also produce documents for internal use.

As Keyrus Life Science being a CRO contracting with clients from different fields of research, the medical writer will have to demonstrate a great versatility, adaptability, curiosity and urge for challenges.

Experience in a variety of disease areas is preferable, but not required.

As a Medical Writer, you will:

• Synthesize literature review findings into reports in various therapeutic area ;

• Write, edit and update clinical development related documents with the highest level of technical accuracy (clinical protocols, informed consent forms, study reports, investigator brochures, clinical trial results, annual reports, statistical analysis plans, briefing documents, paediatric investigational plans and other clinical documents) ;

• Lead the process of critical review of clinical documents and incorporate multiple reviews into successive drafts. Provide quality control (QC) support for clinical documents as needed ;

• Ensure the quality of clinical documents by maintaining and promoting familiarity with International Council on Harmonization Good Clinical Practice (ICH-GCP) guidelines, and other standards ;

• Liaise with authors and clients regarding scientific content ;

• Write, review and edit manuscripts, posters, abstracts… ;

• Attend internal and external team meetings ;

• Respect quality commitments ;

• Participate in the continual improvement of the Quality System ;

• Identify, record and ensure corrections of non-conformities ;

• Update the Medical Writing process and templates and ensure compliance with current regulatory guidelines and best practice ;

• Assist with the development of business proposals related to Medical Writing functions (preparation of budget grids and financial and technical proposals for clients).

Profile:

• PhD degree in science with 2-5 years experience as a medical writer or related field.
• Strong ability with reference management software.
• You are detail-oriented with strong an analytical and organisational mindset.

• You are fluent in French and English (spoken and written) and have a good knowledge of ICH-GCP guidelines.
• You have a good understanding of the significance of clinical, epidemiological, and scientific data in general.

• Excellent writing abilities with strong knowledge of writing formats and methodologies according to Regulatory Agencies and/or document types requirements.
• Must be able to render a concise, accessible and clear content to the client and internal team.
• Experience with the MS Office Suite software with strong formatting skills.
• Adaptability and quick-learning. Meaning, easily grasping the objective of a clinical project and get acquainted rapidly with various health-related research areas.
• Autonomy, sense of initiative and creativity.
• Ability to synthesize information in a short timeframe.
• Ability to work on multiple projects simultaneously while respecting the prescribed deadlines.
• Team player
• Critical thinking

What we offer

• At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.
• We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (meal vouchers, group insurance, hospitalization…) based on your background and experience.

Who we are

• Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high calibre staff, this approach has allowed us to become a key player in clinical research.
• At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently, and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus, we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
• From early- to late-stage drug development, our range of services includes Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.