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Scientist, Scientific Writer 1

  • Anywhere

Company :
Bristol-Myers Squibb

Location :
Summit East, New Jersey

Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT

Apply Job :
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Description :
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Key Responsibilities – Coordinate and author regulatory documents [eg, Investigator’s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), and protocols] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members. – 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. – 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 timely completion and high quality of assigned documents. Qualifications and Experience – Minimum of BS/BA degree in science (PhD/PharmD/Masters degree preferred) with approximately 1-2 years of regulatory documentation or related experience (does not have to be regulatory documentation). All PhD in biological sciences and PharmD candidates are considered. – Strong writing skills in authoring and managing the production of scientific documents (pharmaceutical regulatory documentation and/or publications in peer-reviewed journals). – Ability to analyze and interpret complex data from a broad range of scientific disciplines. – Basic understanding of global pharmaceutical drug development. – Ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team. – Expertise in MS WORD. – Please note the position is not a remote working opportunity and is based in NJ. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.