Bristol Myers Squibb Company

Documentation Specialist

Princeton, NJ, United States
Feb 25, 2019
Required Education
Bachelors Degree
Position Type
Full time
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.

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

Independently manage CARA structure assembly, submission-readiness formatting, and publishing of regulatory documents including clinical study reports, Investigator Brochures, Health Authority responses and clinical protocol documents. Scientific writer for select regulatory document types.

Key Responsibilities and Major Duties

1. Independently partner with GSRD and external authors for CARA structure assembly and document publishing of protocol and submission documents.

2. Mentor, train and provide troubleshooting assistance to GSRD personnel and external authors in PRISM/CARA, Core Template, submission readiness formatting and publishing work processes.

3. Collaborate with cross-function business partners (GCO, GBS, HEOR, early development) providing direction and expertise in SRC formatting and publishing of protocol and submission related documents.

4. Lead cross functional business partners in defining submission-ready requirements for externally authored regulatory documents. Independently manage submission readiness remediation, PRISM import and publishing of externally authored Word and PDF files.

5. Independently manage collection and review of ICH non-data driven appendices for CSRs. Assist cross functional business partners (CTA's, Protocol Managers) in defining submission-ready requirements for ICH non-data driven appendices.

6. Independently coordinate, and/or author select protocol and submission documents types ensuring integration of scientific and regulatory input from team members.

Knowledge Desired

1. Bachelor's Degree with 3-5 years pharmaceutical industry experience with prior regulatory documentation background.

2. In-depth knowledge in desktop applications, (Microsoft Office, Adobe Acrobat), core template and model document usage.

3. In depth knowledge of document management tools (documentum, PRISM/CARA), eCTD documentation standards and publishing work flows.

Experiences Desired

1. Strong experience in CARA structure management, SRC formatting and publishing of internal and externally authored regulatory documents.

2. Demonstrated troubleshooting and training skills in PRISM/CARA, submission readiness formatting and document publishing work flows.

3. Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.

4. Demonstrated ability to manage multiple project timelines and quality of work using strong organizational and interpersonal skills.