Senior Associate Scientist, Technical Writer - Vaccines

Why Patients Need You

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.

What You Will Achieve

This is a non-laboratory-based position within the Vaccine Research and Development – Analytical development group. The candidate will work with scientists to draft, track and issue technical documentation within the GLP laboratory. Documents may include but are not restricted to analytical methods, qualification reports, method deviations, certificates of characterization and other documentation required within the GLP lab operations. Additionally, the candidate will coordinate outsourcing testing activities including gathering quotes, shipping sample materials to CROs, tracking turnaround time and testing status, and ensuring timely completion of testing.

How You Will Achieve It

In this position the individual will be responsible for:

• Documenting qualification of GLP instruments, which includes assembly and issuance of master protocols and executed reports for GLP instruments, and tracking status of GLP instruments and equipment.

• Compiling and issuing change controls for GLP instruments in collaboration with Quality Assurance Group.

• Preparing shipment documents and sending materials to outsourcing vendors. Organizing and tracking outsourcing information such as quotes, testing turnaround times and testing status. Interfacing with the contract lab to follow up regarding testing result availability.

• Drafting and revising methods, qualification reports, specification reports, stability protocols, certificates of characterization, stability reports, etc. Assisting with GLP and non-GLP documentation submission to various documentation portals. Maintaining and tracking documentation submission and approval statuses.

• Supporting sample logging in LIMS.

• Where applicable, performing job responsibilities in compliance with GLP requirements.

Qualifications

Must-Have

• BS or equivalent scientific/ engineering/ pharmaceutical development sciences degree required. Minimum 1-2 years of work experience required.

• Understanding of life sciences with proven technical writing skills. Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. SUBMISSION READY templates and LIMS).

• Familiarity with tracking/change control systems.

Nice-to-Have

• MS or equivalent degree preferred

• Previous GLP experience is a plus.

  
PHYSICAL/MENTAL REQUIREMENTS

Standard conditions – sitting, standing

Other Job Details

Eligible for Employee Referral Bonus

#LI-PFE

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.

Research and Development