Scientific Writer II at Bristol Myers Squibb For PharmD, Apply Now

PharmD Scientific Writer at Bristol Myers Squibb, Apply Now

Scientific Writer II

Locations: Hyderabad – TS – IN

Time type: Full time

Job requisition ID: R1579275

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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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

Position Summary 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.

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), 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.

Qualifications & 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.
• 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.

Please note the position is not a remote working opportunity.

Link to apply: Apply Now

Keywords: Scientific Writer II, Bristol Myers Squibb, Job Posting, Regulatory Documents, Pharmaceutical, Drug Development. PharmD Scientific Writer at Bristol Myers Squibb, Apply Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.