Medical Writer
- Employer
- Bristol Myers Squibb Company
- Location
- Hopewell, NJ, United States
- Start date
- Apr 23, 2019
View more
- Discipline
- Clinical, Medical Writing
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
Position Objective:
- Coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
- Participate in relevant document sub-team(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.
- 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 timely completion and high quality of assigned documents.
- Review and edit documents as required.
- Considerable experience in assignment on Cross Functional Teams would be an advantage.
Qualifications:
- MS/BS with a minimum of 3 years (MS) to 5 years (BS) in the pharmaceutical industry, within pharmacovigilance or safety, with a good understanding of drug development, drug safety, and regulatory/safety document development.
- Demonstrated strong writing skills in authoring and managing the production of scientific documents, specifically authoring PBRERs and DSURS.
- Understanding of documentation requirements related to regulatory filings.
- Basic understanding of global pharmaceutical drug development.
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- 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.
- Candidate should have the ability to speak English.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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