The primary purpose of the Sr. Manager Scientific Writer (SW) position is to provide process oversight and scientific writing support to Vaccine Research and Development (VRD) communication projects in conjunction with the chief scientific officers (CSOs), Vaccine program teams, Vaccine Research teams and Vaccine publication subcommittees (PSCs). The SW is responsible for process oversight of scientific research documents across the VRD portfolio. This position will ensure that the documents that fall within the scope of VRD are completed in a timely manner and with high quality. The SW will also plan and prepare such documents and ensure that document quality and compliance reviews of these documents are performed as necessary. ROLE RESPONSIBILITIES
- Provides experienced process oversight for the development of scientific research documents including nonclinical, exploratory clinical, and research collaboration communications activities, working as a liaison with relevant functional representatives within VRD, including, but not limited to, the CSOs, research program leads, and other VRD members of the vaccine program teams.
- Plans and writes documents that are within the scope of VRD, including, but not limited to, nonclinical sections of regulatory documents, publications, and presentations.
- Leads document preparation activities, including organizing and interpreting scientific and statistical data, writing the documents, and ensuring their review by relevant parties.
- Documents must be of high quality, scientifically accurate, and prepared according to established timelines.
- Leads and/or participates in all relevant meetings for document preparation, such as kickoff meetings, and is responsible for soliciting, interpreting, and incorporating reviewer comments.
- Provides oversight for document quality checks.
- Interfaces with the research scientists and Vaccine Submission Management for data checking and editing, submission-ready checks, compliance reviews, and document archiving for the documents in scope.
- Interfaces with the document owner group when sections of documents are prepared by the SW.
- Conducts literature reviews and may coauthor chapters and scientific reviews.
- Attends program research meetings as needed.
- Liaises with writers and document coordinators from interfacing Pfizer groups or external groups that write or coordinate the completion of additional nonclinical, exploratory clinical, and research collaboration documents, including, but not limited to, Global Product Development, Medical Documentation and Labeling (MDL), Worldwide Safety and Regulatory Operations (WSRO), external researchers, and vendors.
- Ensures common project-specific verbiage (e.g. style guides) and key messages (e.g. results) are consistent across the multiple nonclinical documents written by various groups.
- Ensures consistent document standards are used for all documents within a program.
- Provides document quality review support for nonclinical, exploratory clinical, and research collaboration documents as required, based on program needs.
- This support may include documents written by groups outside of VRD, such as Medical Documentation and Labeling, as requested.
- Provides input on new or revised procedures for document preparation. Provides input into relevant SOPs.
- Other tasks as requested.
- PhD (preferably in biological sciences) plus 4+ years' (or comparable) experience, or MS plus 6+ years' experience, or BS plus 8+ years' experience required.
- Must have strong background in vaccines or infectious diseases.
- Must have at least 4 years of experience with document writing and publication experience (lead author).
- Must have working knowledge of statistics, data analysis, and data interpretation.
- Training preferred in vaccine research, regulatory and publication writing, regulatory affairs/regulations, and computer science applications relevant to the work (e.g. MS Word and working knowledge of submission-ready document templates).
- Experience with document editing, data quality review, and project management preferred.
- Excellent oral and written communication skills required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Work is performed at a work station and requires extended periods of sitting.
Other Job Details:
- Work schedule is a 40-hour week during core business hours, Monday through Friday.
- Project priorities occasionally necessitate work beyond regular work hours, including evenings and weekends.
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
- Eligible for Employee Referral Bonus
- Eligible for Relocation
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.