Scientific Writer
Scientific Writer
Bristol Myers Squibb
Job description
Are you looking for a role where you will work with scientific, medical and regulatory teams to develop clear, accurate and high quality documentation? Explore the Scientific Writer vacancy at Bristol Myers Squibb in Hyderabad, Telangana.
Company Description
Bristol Myers Squibb (BMS) is a multinational biopharmaceutical firm whose mission is to discover, develop and deliver new medicines that help patients prevail over serious diseases. The company is involved in the research, clinical and medicinal development on the basis of its commitment to scientific innovation, collaboration, inclusivity and patient results.
Job Summary
The Scientific Writer will prepare regulatory documents to support clinical development, product approvals and ongoing product lifecycle operations for Bristol Myers Squibb. The regulatory medical writer will be responsible for the coordination of scientific and medical contributions, will take part in the design of papers, will maintain the document templates and will guarantee that the documents entrusted to them fulfill the quality requirements and deadlines.
Key Responsibilities
Prepare and coordinate regulatory documentation including Investigator’s Brochures (IBs), Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Clinical Study Reports (CSRs) and clinical procedures.
Consolidate the scientific, medical and regulatory input from different members of the drug development team in well-organized documents.
Participate in team meetings and help organize the schedules for finishing different sections and components of assigned documents.
Engage in document strategy talks to assist in defining essential messages, logical structure, content flow and consistency.
Keep the templates, prototypes, and shells that are required for regulatory authoring operations.
Follow appropriate internal procedures and external regulatory requirements for document preparation and evaluation.
Supervise document reviews and liaise with relevant team members on concerns, errors and inconsistencies.
Review and revise scientific and regulatory materials to increase clarity, correctness, consistency, and quality
Assist with the timely completion of given documents while ensuring quality requirements are met.
Educational Qualification
PharmD( Doctor of Pharmacy), or PhD in a related scientific field.
Bachelor or Master’s degree in a relevant discipline and approximately 2-4 years of experience in regulatory documentation.
Skills Required
Strong scientific and regulatory writing skills.
Experience in preparation or management of Investigator’s Brochures, safety aggregate reports, clinical protocols and Clinical Study Reports.
Ability to interpret and communicate difficult scientific knowledge, accurately.
Knowledge of pharmaceutical medication development on a global scale.
Excellent organizational and time-management skills to manage different document needs and deadlines.
Good written and verbal communication abilities.
Strong interpersonal and facilitation abilities to work in cross-functional teams.
Knowledge of document management systems.
Basic knowledge of document publishing methods.
Intensive review of scientific content and correction of inconsistencies.
Salary Structure
The average compensation for Scientific Writer in India is estimated to be between ₹8-12 Lakhs per year.
Career Development
This role, as a clinical writer, can support scientific writing experts to expand their experience in regulatory writing, clinical development and cross-functional collaboration. Experience with regulatory submissions and sophisticated scientific studies can also provide a foundation for transitioning into senior regulatory writing or medical writing positions.
How to Apply
Visit our job portal and search for the Scientific Writer post.
Open the job listing for the full qualifications and eligibility criteria.
Fill in your information and upload your resume.
Verify your application details and submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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