Medical Writer I

1 week 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.
- Independently prepare lower complexity protocols and CSRs including interpretation of clinical data and statistical results as appropriate
- Work with more experienced colleagues in the development of higher complexity protocols and CSRs, and other clinical documents as needed
- Independently prepare and review patient safety narratives
- Provide support and project management of narrative projects
- Prepare and/or oversee compilation of CSR appendices
- Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
- Independently review Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) for assigned studies to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
- Incorporate internal and/or external review comments on clinical documentation
- Communicate with internal/external clients as needed to facilitate achievement of project goals
- Participate in meetings with internal and external clients, with guidance and support from colleagues. Lead meetings as appropriate
- Responsible for project coordination and adherence to project timelines and budget, as appropriate
- Represent department in inter-department working groups
- Provide training and guidance to Associate Medical Writers and other staff as appropriate
- 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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