Medical Writer Ii

2 days ago

Mumbai Maharashtra, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate
- Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs
- Prepare and review patient safety narratives
- Leads project management and coordination of narrative projects
- Oversee and coordinate other writers on CSR appendices compilation
- Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
- Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
- Incorporates internal and/or external review comments on clinical documentation
- Prioritize and forward plan workload to a high standard; to advise Management of problems promptly
- Participate independently in internal and external client meetings. Lead meetings as appropriate
- Responsible for project coordination and adherence to project timelines and budget
- Identify ways to improve the efficiency and quality of work processes
- Mentor Associate Medical Writers and Medical Writer I, as appropriate
- Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience
- Provide training to Medical Writers and other staff as appropriate
- Represent department in audits and inter-department working groups
- Comply with Covance internal processes and procedures
- Performs other duties as assigned by Management

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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