Medical Writer I

2 weeks ago

Hyderabad, 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.

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.

**Position Summary**:
The Pharmacovigilance (PV) Medical Writer will be responsible for collaboratively authoring and revising key drug safety-focused documents and reports for submission to Regulatory Health Authorities worldwide. This role will work closely with medical and safety colleagues to prepare accurate and concise analyses of safety data to support development of new treatments as well as support post-marketing safety activities for approved agents.

**Principal Responsibilities**:
Includes but not limited to (based on role/functional allocation):

- Lead the authoring and editing of periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, Addendum Reports and Signal Reports in collaboration with risk management), safety scientists, SMT colleagues and other key stakeholders.
- Lead the authoring and editing of risk management documents including but not limited to Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy (REMS) plus core or regional additional risk minimization measures in collaboration with Global Risk Management, Safety Scientists, Local Market Patient Safety, SMT colleagues and other key stakeholders.
- In collaboration with cross-functional teams, contribute safety information to Health Authority reports and Information Requests as needed, both internally and externally
- Understand relationships and dependencies between documents and ensure consistency in information presented in aggregate reports and RMPs with other program documents (e.g., IBs, product labeling, CTD) to ensure alignment of safety messaging across all safety risk related documents.

In conjunction with leading collaborative authoring, the Sr. PV Medical Writer will be responsible for project management, including but not limited to:

- Developing timelines for team endorsement
- Setting up and effectively leading comment resolution meetings
- Working with the project team to resolve comments or gain team consensus
- Leading the document through authoring, formatting, review, approval, medical writing QC, initiation of workflows through eDMS, and publishing support

In conjunction with cross-functional team, the Sr. PV Medical Writer will translate regulatory guidance and lead template development for PV medical writing templates

Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues

Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission

Train new/existing staff to fulfill their role of responsibility

Execute strategic safety data analyses, and presentation of safety data and benefit-risk assessment in documents

Represents medical writing on project teams and contributes to program strategy, through collaborative engagement with cross-functional personnel

Draft other safety medical writing deliverables as needed

**Required Qualifications by Level:
**PV Medical Writer 1: Non-strategic Writing; Formatting, Publishing
- PharmD/PhD/MD or MS / BS in a relevant scientific discipline with a minimum of 1-year (MS) to 2 years (BS) experience with Scientific Writing in drug development
- Directive updates of existing documents; junior level writer functioning under the supervision of mentor/lead writer

**Preferred Qualifications**

Experience with Safety Aggregate Reports and Risk Management Plans (RMPs).

Collaborative writing experience.

Excellent project management to meet timelines agreed upon, written and verbal communication skills, with the ability to interpret and present information to varied audiences.

Ability to coordinate and prioritize multiple projects in a fast-paced matrix environment with limited to little supervision.

Knowledge of FDA and EMA regulations, Guideline on Good Pharmacovigilance Practices Module V and XVI, ICH guidelines,

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