Scientific Writer II
Bristol-Myers Squibb · Hyderabad · onsite · Posted 27d ago
Undisclosed2–4 yrsfulltimeSourced from
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About this role
At Bristol Myers Squibb, our employees often ask, Who are you working for-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Responsibilities
- Coordinate and author regulatory documents [eg, Investigators 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.
- Review and edit documents as required.
- PharmD/PhD in a relevant scientific discipline or Masters/Bachelors 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
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Document Managementdrug developmentdata privacylosAuthoringregulatory documentationCSRscientific writerBrochuresPharmaceutical
About Bristol-Myers Squibb
Bristol-Myers Squibb
Pharma
375
employees
1887
139 years old
New York
United States
₹19.1L PA avg
Avg at Bristol-Myers Squibb
About
We are a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. At Bristol Myers Squibb, we work every day to transform patients’ lives through science. We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
We have the brightest people in the industry and believe that their diverse experiences and perspectives help to bring out our best ideas, drive innovation and achieve transformative business results. Each day, our employees around the world work together for patients – patients are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We are proud of the advancements we have made in oncology, hematology, immunology, and cardiovascular disease, and we are dedicated to helping patients prevail over serious diseases through our diverse and promising pipeline and new scientific platforms. We are pursuing therapies at the forefront of scientific discovery with the goal of bringing an exciting new generation of life-changing treatments to patients. We aspire to be at the center of a vibrant healthcare innovation ecosystem, where academic research centers, biotech, and biopharma companies all contribute to continued scientific advancement.
Industries
PharmaBiotech & Life sciences
Employee ratings
10 reviews
3.7/ 5
Culture
2.6
Career growth
2.2
Work-life
3.1
Employees rate it well for
Work-Life Balance38Compensation & Benefits37
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