Senior Scientific Writer I

3 weeks ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

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 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.

#HYDDD

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