Pfizer

Associate Research Fellow, Scientific Communications

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Posted
November 19 2020
Ref
4795309
Position Type
Full Time
Organization Type
Pharma
The primary purpose of the Associate Research Fellow, Scientific Communications (ARFSC) position is to provide leadership, scientific, and project management 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 ARFSC is responsible for high-level, experienced project management support of translational research documents across the VRD portfolio. This position will ensure that the documents that fall within the scope of the VRD group are completed in a timely manner and with high quality.

The ARFSC will also plan and prepare such documents and ensure that document quality and compliance reviews are performed as necessary for those documents.

The ARFSC may act as a liaison between VRD and other interfacing groups such as the PSCs, as necessary, and provide them with critical information on Vaccine program communication strategy, timelines, therapeutic area expertise, key program messages, and vaccine-specific document requirements to ensure consistency and quality across all nonclinical, exploratory clinical, and research collaboration documents within a program.

  • Provides experienced high-level project management support on a program level for translational research documents including nonclinical, exploratory clinical, and research collaboration communications activities, working in collaboration and 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 the VRD group, including, but not limited to, nonclinical sections of regulatory documents, publications , and presentations.
  • Provides such leadership for required document preparation, including organizing document preparation, interpreting scientific and statistical data, writing the documents, and ensuring their review by relevant parties.
  • Documents must be of high quality, scientifically accurate, and be 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 over sight for the 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 ARFSC .
  • Conducts literature reviews and may coauthor chapters and scientific reviews.
  • Attends Vaccine Publication Subcommittee meetings and coordinates with the CSOs and the research scientific leads to develop and present the nonclinical and exploratory clinical publication strategies.
  • Reports back to the CSOs regarding the PSC output.
  • Attends Program Research meetings as needed.
  • Tracks nonclinical writing requirements across programs, as necessary.
  • Liaises with writers and document coordinators from interfacing Pfizer groups or external groups that write or coordinate the completion of additional nonclinical , ex ploratory 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 that VRD writing needs are met within the context of the program and clinical project team, writers in those groups receive appropriate information on the vaccine therapeutic area and program, and these groups understand project priorities, required documents, and timelines.
  • Provides and/or coordinates program-level training for interfacing writers, as necessary.
  • 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.


QUALIFICATIONS
  • PhD (preferably in biological sciences) plus 8+ years' (or comparable) experience, or MS plus 10+ years' experience, or BS plus 12+ years' experience required.
  • Must have strong background in vaccines or infectious diseases.
  • Must have strong background in vaccines or infectious diseases.
  • Must have at least 8 years of experience with document writing and publication experience (lead author).
  • Must have working knowledge of statistics, data analysis, and data interpretation.
  • Preferred experience in regulatory systems and processes within and outside the US.
  • 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.


PHYSICAL/MENTAL REQUIREMENTS
  • Work will be performed in a work station/office and requires sitting.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • 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.


ORGANIZATIONAL RELATIONSHIPS
  • Reports to Group Lead, Clinical Scientist Communications Leads.
  • Takes direction from and prioritizes work based on regular engagement with the Vaccine R&D CSOs (Viral & Bacterial Vaccine R&D Chief Scientific Officers).
  • Interacts with authoring and contributing lines within Vaccine Research.
  • Interacts with external authors and colleagues from other Pfizer business lines and companies (Worldwide Safety and Regulatory Affairs, Global Product Development, and publications vendors).


Other Job Details:
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES


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