Position: Scientific Writer/Senior Scientific Writer

Location: Hyderabad

Position Summary

To coordinate and author complex documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.

Key Responsibilities
• Authors complex clinical documents [eg, Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries] for timely submission to health authorities worldwide according to:
• good documentation principles (organization, clarity, scientific standards)
• consistency between text and tabular presentations or graphical displays
• in compliance with BMS documentation standards and worldwide regulatory requirements
• 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.
• Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and 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:
• optimal communication between authoring team and development team members
• coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
• timely completion and high quality of assigned documents
• Review and edit documents as required.
• Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.
• Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

Qualifications & Experience
• PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 5-10 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
• Demonstrated strong writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (e.g., briefing documents, CTD summary documents, responses, pediatric plans)..
• Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
• 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.

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