Spec I Pss

1 month ago

Mumbai, India Fortrea - Organic 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.

Job Description:

- Write various safety reports (or part of such reports) for global regulatory submissions for clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned.
- Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
- Write Investigator Brochures and sections of/entire protocols
- Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
- Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences,
- Prepare medical information responses for HCPs
- Internal and external (client) communication & co-ordination to get the required inputs
- Creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides
- Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document

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.

For more information about how we collect and store your personal data, please see our

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