Fortrea, a global leader in contract research, is actively hiring for the role of Medical Writer II – Clinical Development Services (CDS) in Mumbai, India. With a rich history of scientific rigor and clinical development expertise, Fortrea partners with pharmaceutical, biotechnology, and medical device industries to offer groundbreaking clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in over 90 countries, Fortrea is driving innovation in drug and device development to bring transformative therapies to patients worldwide.

Key Responsibilities of a Medical Writer II – CDS

The Medical Writer II at Fortrea will be responsible for preparing vital clinical documents that contribute to advancing clinical research and patient care. Key duties include:

1. Document Preparation: Draft manuscripts, clinical study reports (CSRs), and protocols, ensuring accurate interpretation of clinical data and statistical results.
2. Project Management: Lead the coordination and management of manuscript and narrative projects, ensuring timelines and budgets are met.
3. Patient Safety Narratives: Prepare and review patient safety narratives with precision.
4. Team Collaboration: Work closely with colleagues to develop complex clinical documents and ensure smooth project delivery.
5. Regulatory Compliance: Ensure all documents align with Covance/Client SOPs, ICH, and industry guidelines.
6. Data Review: Participate in reviewing Statistical Analysis Plans (SAP) and Tables, Figures, and Listings (TFLs), offering feedback for accurate data representation.
7. Training & Mentoring: Mentor junior medical writers, offer peer reviews, and provide necessary training to team members.
8. Quality Improvement: Identify and implement improvements in work processes to enhance efficiency and quality.
9. Client Interaction: Actively participate in client meetings, leading discussions when needed.

Qualifications Required for the Role

To be successful in the role of Medical Writer II, candidates are expected to meet the following qualifications:

• Education: A degree in Life Sciences, Medicine, Pharmacy, or a related field.
• Experience: Prior experience in clinical writing, particularly with manuscripts, CSRs, and protocols, is essential.
• Knowledge: Familiarity with clinical trials, ICH guidelines, and regulatory processes.
• Skills: Strong written and verbal communication skills, attention to detail, and the ability to manage multiple projects simultaneously are key.

Essential Skills and Attributes

Candidates applying for the Medical Writer II role should possess:

• Strong Analytical Skills: The ability to interpret and present clinical data effectively.
• Project Coordination Expertise: Experience in managing timelines, budgets, and resources efficiently.
• Collaboration and Leadership: An ability to work with cross-functional teams and guide junior writers.
• Compliance and Quality Focus: Ensuring all documents meet regulatory standards and internal guidelines.
• Adaptability: Willingness to take on additional duties and contribute to ongoing process improvements.

Application Link