Scientific Writer

Position: Scientific Writer 2

Location: Hyderabad (2-3 days work from office, in a week)

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

• Coordinate & author 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:

1. good documentation principles (organization, clarity, scientific standards)
2. consistency between text and tabular presentations or graphical displays
3. 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:

1. optimal communication between authoring team and development team members
2. coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
3. timely completion and high quality of assigned documents

• Review and edit documents as required.

Qualifications & Experience

• PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 4-8 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 IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
• 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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