Senior Scientific Writer at BMS. Interested candidates can check the details below and apply online.
Job role: Senior Scientific Writer 1
Job ID: R1572059
Job Location: Hyderabad, India
Position Type: Full Time
Categories: Regulatory Affairs
Job Description
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.
Position Summary
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.Key Responsibilities of Senior Scientific Writer at BMS
- 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
- 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.
Qualifications & Experience
- 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.
- 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.
- If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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.
Possible interview questions with answers for the job role of Senior Scientific Writer at BMS:
1:Can you provide an example of a complex clinical document you have authored for regulatory submissions? How did you ensure compliance with good documentation principles and worldwide regulatory requirements?
A: Certainly. In my previous role at XYZ Pharmaceuticals, I authored a Phase 2 Clinical Study Report (CSR) for a novel drug candidate. To ensure compliance with good documentation principles, I meticulously organized the content, maintained clarity in scientific explanations, and followed BMS documentation standards. I collaborated closely with cross-functional teams to integrate scientific, medical, and regulatory inputs. The document was successfully submitted to health authorities worldwide, and its approval highlighted the alignment of text, tabular presentations, and graphical displays with consistent messaging.
2: Could you describe a time when you had to manage a complex document subteam to meet tight timelines for a regulatory submission?
A: Certainly. In a recent project, we had a challenging deadline to prepare an Investigator’s Brochure (IB) for a new compound. I led a document subteam composed of members from various disciplines. To meet the tight timeline, I facilitated effective planning, clearly defined responsibilities, and maintained regular communication. By leveraging my organizational and communication skills, we successfully coordinated contributions from team members, ensuring the IB’s completeness and accuracy. The final document was submitted on time, contributing to the project’s overall success.
3: How do you approach maintaining consistency and logic in document flow and messaging during document prototyping sessions for regulatory projects?
A: During document prototyping sessions, I ensure that the document flow and messaging are cohesive and logical. I collaborate with cross-functional teams to establish clear document outlines and maintain consistency in content. I pay particular attention to the alignment of messaging with the overall project objectives and regulatory requirements. By meticulously reviewing and refining the prototypes, I ensure that they serve as reliable templates for subsequent documents. This approach not only enhances document quality but also facilitates efficient collaboration among team members.
4: Can you share an example of a situation where you had to address discrepancies between internal development plans and documentation for regulatory submissions?
A: Certainly. In a recent project, I identified a discrepancy between the internal development plan and the Clinical Study Report (CSR) that was being prepared for regulatory submission. The CSR lacked consistency in messaging and content flow with the development plan. I immediately engaged in discussions with relevant stakeholders to align the two documents. Through open communication, we resolved the discrepancies, ensuring that the CSR accurately reflected the project’s progress and objectives. This experience highlighted the importance of continuous cross-functional collaboration to maintain coherence between internal strategies and external regulatory documents.
Senior Scientific Writer at BMS
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