BMS Pharma Scientific Writer Vacancy – Apply Online
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Job Title: Scientific Writer II
Location: Hyderabad, India
PharmD/PhD or Master’s/Bachelor’s degree with prior experience
PharmD/PhD in a relevant scientific discipline or Master’s/Bachelor’s degree with approximately 2-4 years of regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
Key Competency Requirements
- Demonstrated strong writing skills in authoring and managing the production of IB,
- Safety Aggregate Report, Clinical Protocols, and/or CSR.
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- Understanding of global pharmaceutical drug development.
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Working knowledge of a document management system and basic knowledge of the document publishing process.
Position Summary / Objective
To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
- Coordinate and author regulatory documents [eg, Investigator’s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), protocols, and high-level summary documents] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
- Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
- Maintain document prototypes and shells.
- Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
- Review and edit documents as required.
Functional Area Description
Leads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets (US, EU, China, Japan) and other geographies. Provides support for fit-for-purpose regulatory documents (nonclinical, clinical pharmacology, translational medicine, clinical, safety) to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.
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