Senior Medical Writer at Avalere Health producing editorial content to support healthcare communication goals. Collaborating with teams to deliver quality projects on time and within budget.
About the role
- Senior Medical Writer at ICON plc leading development and execution of medical writing strategies for clinical research projects. Contributing to new treatments and therapies through documentation and collaboration.
Responsibilities
- Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions
- Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs
- Participating in the planning and execution of clinical development programs
- Contributing to the development of publication plans, abstracts, posters, and manuscripts
- Mentoring and coaching junior medical writers, providing guidance on best practices.
Requirements
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
- Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses
- Excellent writing, editing, and proofreading skills
- Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
- Demonstrated ability to work effectively in a fast-paced, deadline-driven environment
- Excellent interpersonal and communication skills.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Clinical Writer preparing regulatory and clinical documentation for innovative medical devices at Withings. Collaborating with technical teams and ensuring compliance with medical regulations.
Medical Writer at Kintiga preparing AMNOG and JCA dossiers, supporting strategic planning and G - BA consultations. Focused on quality deliverables using expertise in the healthcare and life sciences sector.
Medical Writer preparing clinical regulatory documents in collaboration with client teams. Contributing to the production of high - quality regulatory documentation for the international pharmaceutical industry.
Senior Medical Writer leading complex writing projects and managing writing activities at Syneos Health. Collaborating with medical teams while adhering to regulatory standards.
CDI Specialist reviewing medical records and facilitating documentation improvement at Ensemble Health Partners. Requires acute care nursing experience with a focus on Pediatric/NICU.
Manager overseeing Clinical Documentation Improvement (CDI) program and staff at multiple Illinois locations. Ensuring accurate documentation and coding practices while collaborating with healthcare professionals.
Medical Writer II providing strategic writing expertise for Clinical Evaluation Reporting documents at Abbott. Collaborating on clinical evaluation projects for medical devices across multiple sites.
Principal Medical Writer managing major client accounts at Madano, delivering strategic, scientifically rigorous content and overseeing a scientific services team.
Senior Medical Writer creating scientifically robust communications for healthcare. Collaborating with cross - functional teams to drive impactful content delivery.