This secondment position is considering applicants at the R4 to R5 levels.
WHY PATIENTS NEED YOU
At Pfizer, our purpose is to deliver breakthroughs that change patients' lives. Central to this mission is our Research and Development team, which strives to translate advanced science and innovative technologies into impactful therapies and vaccines. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your role is crucial. You will leverage cutting-edge design and process development capabilities to accelerate the delivery of best-in-class medicines to patients globally.
WHAT YOU WILL ACHIEVE
Support the group's core analytical authoring objectives for upcoming ongoing BLA submissions.
Assist in the authoring of analytical sections, ensuring alignment with regulatory strategy, platform precedents, and health authority expectations.
Help drive integration and interpretation of analytical data (release, stability, characterization) into clear, defensible regulatory narratives.
Identify, evaluate, and implement emerging AI and digital technologies to enhance regulatory authoring processes, improve team efficiency, and expand the group's capabilities in support of evolving business needs.
Assist in developing and refining ARD regulatory strategy to ensure consistent, defensible submission narratives.
Leverage your individual background and expertise to expand the groups scope into additional analytical areas (e.g., stability, method development/evolution, comparability).
Assist in the development of analytical strategies and template guidance for CTD sections in collaboration with ARD SME’s.
HOW YOU WILL ACHIEVE IT
Hands-on experience authoring high-impact analytical Module 3 sections for late-stage regulatory submissions.
Increased visibility and collaboration with cross-functional partners (e.g., ARD, PhRD, BRD, GCMC, PGS).
Ability to contribute to, and influence, analytical regulatory strategy across the BTx Pharm Sci portfolio.
QUALIFICATIONS
Must-Have
Applicant must have a bachelor's degree with at least 9+ years of experience.
Experience in biological drug development and familiarity with analytical strategies to support product development and evaluate the quality and characteristics of biotherapeutics.
Experience working in interdisciplinary drug development teams.
Direct experience with clinical and commercial biologics submissions.
Experience in developing and implementing analytical control strategies for biotherapeutics.
Strong communication skills and the ability to work independently.
Experience with both analytical laboratory data and process-relevant data.
Strong written and verbal communication skills.
Proficiency in MS Office.
Ability to manage multiple projects and prioritize tasks effectively.
Nice-to-Have
Master's degree with at least 7+ years of experience; OR a PhD with 0+ years of experience.
Demonstrated ability to work independently to identify strategic opportunities for process improvement, proactively expand functional capabilities, and lead initiatives that broaden group scope, responsibilities, and organizational impact in support of evolving business needs.
Experience leveraging AI and generative AI tools to enhance productivity and problem-solving, while proactively identifying and implementing new AI solutions to expand team capabilities and efficiency.
Prior experience as an ARD Lead, BIS Rep, CAS Rep, and/or CAS-HC Rep.
Strong attention to detail and accuracy.
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require occasional travel to other sites.
OTHER JOB DETAILS
Last Date to Apply for Job: July 24, 2026
Additional Location Information: MA – Andover, WA – Bothell
Eligible for Relocation Package – NO
Secondment 12 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
There will be no change to your current work location.
Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email
disabilityrecruitment@pfizer.com
. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Research and Development