Bristol Myers Squibb Biological Sciences Scientific Writer I Job Opening, Apply Online

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.

Functional Area Description –

Leads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets (US, EU, China, Japan) and other geographies. Provides support for fit-for-purpose regulatory documents (nonclinical, clinical pharmacology, translational medicine, clinical, safety) to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.

Position Summary / Objective – 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.

Position Responsibilities

• Authors complex clinical documents [eg, Investigator’s Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health
• Authority queries] for timely submission to health authorities worldwide according to: good documentation principles (organization, clarity, scientific standards), consistency between text and tabular presentations or graphical displays, and in compliance with BMS documentation standards and worldwide regulatory requirements
• 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.
• Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and 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 optimal communication between authoring team and development team members, coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation, timely completion, and high quality of assigned documents
• Review and edit documents as required.
• Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.
• Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

Degree Requirements

• PhD/MD/PharmD or MS/BS with prior experience Experience Requirements – PharmD/PhD in a relevant scientific discipline or Master’s/Bachelor’s degree with approximately 5 years of pharmaceutical regulatory documentation.
• All PhD in biological sciences and PharmD candidates are considered. Key Competency Requirements
• Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
• Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
• 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.

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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 is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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Hey there, looking for assistance with the possible interview questions and the answers for the role of Scientific Writer I at Bristol Myers Squibb? Then check them out below

1. Can you describe your experience in authoring complex clinical documents for regulatory submissions? How do you ensure compliance with documentation standards and regulatory requirements?
   • Answer: In my previous role, I have authored Investigator’s Brochures, Protocols, Clinical Study Reports, and other regulatory documents. I ensure compliance by following good documentation principles, maintaining consistency, and adhering to BMS documentation standards. I stay updated with worldwide regulatory requirements to ensure timely submission to health authorities.
2. How do you approach document strategy and planning for regulatory submissions? Can you provide an example of a project where you successfully coordinated cross-functional team members’ input?
   • Answer: When planning for document strategy, I participate in sessions to discuss messaging, document flow, logic, and consistency. I ensure effective coordination among cross-functional team members to integrate scientific, medical, and regulatory input. For instance, in a recent project, I collaborated with various disciplines to align on document content, timelines, and submission requirements, resulting in a smooth process.
3. How do you handle issues or inconsistencies during the review process of regulatory documents? Can you share an experience where you resolved such issues to ensure optimal communication and high-quality documents?
   • Answer: During the review process, I actively engage with team members to identify and resolve issues or inconsistencies. I maintain open communication channels to address concerns promptly. In a previous project, I encountered discrepancies in data interpretation between different teams. By facilitating discussions and aligning on interpretations, we achieved a cohesive document with accurate and consistent information.
4. What is your understanding of global pharmaceutical drug development and its impact on regulatory documentation? How do you stay updated with evolving requirements?
   • Answer: I have a solid understanding of global pharmaceutical drug development and its connection to regulatory documentation. I continuously stay informed about evolving requirements through extensive literature review, attending industry conferences, and participating in relevant training programs. This helps me adapt to changing guidelines and ensure compliance in my documentation.
5. How do you manage timelines and maintain the quality of your work in a cross-functional team environment? Can you provide an example where you successfully balanced both aspects?
   • Answer: I excel in managing timelines and maintaining high-quality work by utilizing strong organizational and communication skills. In a previous project, we had a tight deadline for a regulatory submission. By effectively coordinating with team members, setting clear milestones, and prioritizing tasks, we met the deadline without compromising the quality of the document. Regular progress tracking and effective collaboration were key to our success.

Remember, these are sample questions, and it’s essential to tailor them to the specific job description and candidate’s experience during the interview process.

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