Safety Narrative Writer

3 months ago

Hyderabad Telangana, India Bristol-Myers Squibb Full time

**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.

Key Responsibilities
- Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
- Serves as primary contact for narrative writing for an assigned study, deliverable timelines, and addressing/resolving any narratives related issues (as required)
- Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesiveness
- Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting.
- Participates in process improvement activities to develop patient safety narratives.

Qualifications & Experience
- College or university degree, preferably a Bachelor's/Master's degree in biomedical or life sciences fields
- Minimum 2-5 years of experience working with clinical documentation and data
- Prior pharmaceutical, biotechnology, or contract research organization experience
- Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process
- Basic knowledge of electronic Common Technical Document (eCTD) requirements
- Demonstrated capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
- Working knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews.
- Ability to manage timelines and quality of work using strong organizational, communication, and facilitation skills.
- Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.

**Why You Should Apply**

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.

HYDDD

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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.

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