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Bioprocess R&D Scientific Documentation Facilitator


Saint Louis, MO
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Job Details

Job Title Bioprocess R&D Scientific Documentation Facilitator

JobID 1048243-1852

Location: St. Louis, MO

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

The Bioprocess R&D Scientific Documentation Facilitator serves as a focal point within BRD for work processes focused on documentation authoring, review, data verification and document storage (e.g. GDMS). The initial emphasis will be on supporting late stage teams through data verification of BLAs, and to assist with definition of work processes, documentation guidelines, and training. As work processes are defined and implemented the Scientific Documentation Facilitator will also author regulatory documents using templates and source documents. This role supports all BRD project teams across each of the four sites.


*Perform data verification of Biologics License Applications, Investigational New Drug Applications and other regulatory documents in compliance with Pfizer internal Standard Operating Procedures.*Working with BRD and DS Subteams, author specific CMC sections of regulatory documents using templates and technical reports. *Identify gaps in regulatory documentation readiness and work within BRD to define and implement solutions (e.g. definition of source documents, creation of report templates, etc.)*Serve as point of contact for sharing lessons learned/best practices for systems and work practices around scientific documentation (e.g. GDMS).*Contribute to BRD Portfolio Group initiatives with a focus on defining and implementing best practices for BRD project teams.*Contribute to tracking regulatory documentation progression within BRD and other scientific documentation metrics.


Education and Experience:*BS in Molecular or Cell Biology, Biochemistry, Biological Sciences/Life Sciences, Chemical/Biological Engineering, or equivalent. *5-7 years related experience in development of biological therapeutics and/or vaccines within the biopharmaceutical industry. *Excellent written and oral communication skills, with experience in technical writing of reports and/or regulatory documents.*Excellent computer skills including expertise in MS Office, Sharepoint, and documentation management.*Ability to prioritize and manage multiple activities and objectives simultaneously.*Ability to work independently on individual goals and contribute collaboratively to team goals. *Highly developed organizational skills. *Familiarity with regulatory/ICH guidelines highly desirable.*Potential to take on larger leadership and organizational roles.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Role may include travel (up to 10%) to other Pfizer sites.

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*Bioprocess R&D Scientific Documentation Facilitator*
*St. Louis, Missouri*

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