Scientific Writer I

2 weeks ago

Hyderabad, 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**
- Coordinate and author regulatory documents [eg, Investigator’s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), and protocols] 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.

**Qualifications & Experience**
- Strong writing skills in authoring and managing the production of scientific documents (pharmaceutical regulatory documentation and/or publications in peer-reviewed journals).
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- Basic understanding of global pharmaceutical drug development.
- Ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Expertise in MS WORD.

HYDDD #LI-Hybrid

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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