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.ROLE SUMMARY
The Pharmaceutical R&D (PhRD) Scientific Writer Coordinator will collaborate with Biologics Drug Product (DP) and Device Subteams to support authoring of Biologics License Applications (BLAs), query responses, and technical reports / supportive documents for biologic drug products. This position will also engage in sourcing and managing contract support of related activities (including data verification). The incumbent will help identify best practices for improvement of quality, efficiency and productivity of the regulatory authoring work process.
Supports project teams in authoring of regulatory dossiers, with about 50% of time spent on logistical aspects of managing workflow (including contract support for data verification) and 50% of time spent on writing/editing. Role is a balance of expert authoring and expert organization and customer support.ROLE RESPONSIBILITIES
- Managing contractors, providing training, supervising work for quality and on-time delivery, trouble-shooting and issue resolution support
- Managing budgets, contracts / work orders / purchase orders for contractor support
- Interfaces with Pfizer Digital organization for continuous improvement
- Work collaboratively with Biologics Pharmaceutical R&D, DP & Device Subteams, Commercial manufacturing sites and other biologics PharmSci lines to provide Chemistry, Manufacturing and Controls (CMC) writing support in authoring of BLAs, technical reports, risk assessments, and other regulatory documents in compliance with Pfizer internal Standard Operating Procedures and business practices.
- Coordinate with DP Subteam lead, Device subteam lead if applicable, and technical leads to support PhRD authoring for project specific submissions, and coordinate management of additional contract support as needed.
- Identify and mitigate gaps in regulatory documentation readiness through defining source documents, creating report templates, identifying best practices, etc. in collaboration with primary stakeholders.
- Contribute to PhRD initiatives around defining and implementing best practices for DP authoring teams. Specifically, ensuring sharing lessons learned/best practices for systems and work practices around authoring regulatory documents and technical reports.
- Contribute to tracking of regulatory documentation progression within PhRD and other scientific documentation metrics.
- Coordinate with DP (& Device) Subteams and Regulatory CMC teams to prepare timely responses to regulatory queries.
- BS in Pharmaceutical Science, Biochemistry, Biological Sciences/Life Sciences, Chemical/Biological Engineering, or equivalent.
- 7 - 10 years related experience in development of biological therapeutics and/or vaccines within the biopharmaceutical industry, ideally biologic drug product development.
- Experience in authoring Regulatory submissions (including BLAs) and technical reports. Familiarity with Common Technical Document (CTD) structure and content.
- Excellent written and oral communication skills, skill in written English (grammar, spelling, punctuation), attention to detail
- Passion for writing and articulation of strategic message
- Skilled with computers, MS Office (particularly Word with add-ins for submission ready formatting) and document management systems (eg. Documentum based), agile with technology
- Ability to prioritize, manage and deliver on multiple activities and objectives simultaneously, meets deadlines.
- Ability to work independently on individual goals and contribute collaboratively to team goals; enjoys achieving goals through collaborative effort.
- Demonstrated excellent collaboration and teamwork skills, understands "customer service" mindset in team support. Ability to work in a matrix organization.
- Highly developed organizational & logistical skills, adept at planning and tracking of activities & deliverables against timelines, skilled at identifying conflicts in advance.
- Basic financial and business acumen to manage budgets, contracts and Purchase Orders for external contract support.
- Ability to coach and guide others, deliver training, manage contractors, trouble-shoot issues.
Other Job Details
- Knowledge of relevant regulatory agency guidance including ICH, FDA, and EMA.
- Experience with data integrity verification tools and concepts.
- Facile with electronic laboratory notebook systems, LIMS systems, , and regulatory applications.
- Familiar with regulatory document publishing.
Work Location Assignment: Flexible
Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.
Relocation assistance may be available based on business needs and/or eligibility.
\nPfizer 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.
Research and Development