Scientific Writer I (PSSW)
Bristol-Myers Squibb · Hyderabad · onsite · Posted 21d ago
Undisclosed1–2 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Position Summary
Duties/Responsibilities:
Reporting Relationship:
Qualifications:
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.
Leads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets and other geographies. Provides support for fit-for-purpose regulatory documents (clinical pharmacology, clinical, safety) to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.
Objective: 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.
Duties/Responsibilities:
- Coordinate and author complex safety aggregate reports, risk management documents and 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.
Reporting Relationship:
Senior Manager II
Qualifications:
- Minimum of BS/BA degree in science (PhD/PharmD/Master's degree preferred) with approximately 1-2 years of regulatory documentation or related experience (does not have to be regulatory documentation). All PhD in biological sciences and PharmD candidates are considered.
- 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 Office.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
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
drug developmentdata privacylospharmacologybsregulatory submissionsAuthoringClinical Pharmacologyregulatory documentationCSRscientific writerRisk ManagementBrochuresPharmaceutical
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.
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