SA Scientist Documentation Facilitator

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

As a Senior Associate Scientist, you will provide scientific and technology expertise in BioProcess Research and Development (BRD) to advance our biotherapeutic portfolio with a focus on supporting regulatory filings. You will perform BRD activities, such as data verification of regulatory documents, coordination of document transfer for in-licensed and out-licensed projects, and management of risk assessment documentation. Your work will be essential to advance regulatory filings for our investigational productions through your direct contribution to individual projects, and through supporting definition of work processes and best practices across the portfolio. You will be proactive in contributing to relevant team discussions and fostering an environment of collaboration.

• Provide data verification of Biologics License Applications, Investigation New Drug Application and other regulatory documents in compliance with Pfizer Internal Standard Operating Procedures.
• Identify and mitigate gaps in regulatory documentation readiness through defining source documents, creating report templates, identifying best practices, etc.
• Contribute to and deliver fit-for-purpose data verification training for BRD authors
• Contribute to BRD Portfolio Group initiatives for defining and implementing best practices for BRD project teams.
• Contribute to tracking regulatory documentation progression within BRD.
• Contribute to achievement of immediate work group goals and collaborate with other team members.
• Work with BRD project teams to coordinate BRD document transfer from in-licensing partners and build tracking tools to support product knowledge management.
• Help manage risk assessment documentation for BRD project teams.
• Assist with out-license documentation tracking

• Bachelor's Degree in Genetics, Molecular/Cellular Biology, Biochemistry, Biological Sciences/Life Sciences, Chemical/Biological Engineering, or equivalent
• 1-3 years of experience related experience in development of biotherapeutics and/or vaccines within the biopharmaceutical industry
• Potential to take on larger leadership and organizational roles
• Ability to prioritize and manage multiple activities and objectives
• Ability to work and communicate effectively across functional lines
• Collaborative and team oriented work style
• Excellent oral and written communication skills
• Excellent computer skills -
• Highly developed organizational skills

Familiarity with regulatory/ICH guidelines highly desirable

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Role may include travel (up to 10%) to other Pfizer sites.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.