Medical Writer

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 questions, objectives, and outcomes. She/he will provide educated guesses, advice, and feedback regarding clinical study designs and methodologies. The Medical Writer will produce clinical protocols, build study designs along with the statistical team, conduct literature reviews, write investigator brochures, and research proposals, to name a few. She/he will also produce documents for internal use.

As Keyrus Life Science is a CRO contracting with clients from different fields of research, the Medical Writer will have to demonstrate great versatility, adaptability, curiosity, and an 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 areas;
• 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, pediatric 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, etc.;
• 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 practices;
• 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 of experience as a medical writer or in a related field.
• Strong ability with reference management software.
• You are detail-oriented with a strong analytical and organizational 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 type requirements.
• Must be able to render 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 becoming 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 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 delivering excellence. Our ‘human’ approach to service provision differentiates us from our competitors. Combined with our high-caliber 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 skillfully, 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, and Real World evidence services.