The primary purpose of the Clinical Scientist Communications Lead (CSCL) position is to provide leadership, scientific, and project management support to clinical communication projects in conjunction with the Clinical Leads, Study Clinicians, and interfacing clinical document preparation groups. The CSCL is responsible for high-level, experienced project management support on at least one clinical program for tasks focusing on clinical communication activities on Phase 1- Phase 4, global clinical programs. This position will ensure that the clinical documents that fall within the scope of the Vaccine Clinical Research & Development (VCRD) group, within at least one clinical program, are completed in a timely manner and with high quality. The CSCL will also plan and prepare such clinical documents and ensure that document quality review is performed as necessary for those documents within the scope of VCRD. This position will also work in collaboration with leads from interfacing groups who are responsible for preparation of additional clinical documents to ensure that critical writing needs and timelines are communicated and completed for all Vaccine Research programs in support of global and regional (e.g. Japan) regulatory submissions within the program, as necessary. These groups include but are not limited to Global Product Development, Development Japan, Worldwide Safety and Regulatory Operations, Vaccine Research Clinical Leads, Medical Documentation and Labeling, Japan Vaccine Research, and Vaccine Research Study Clinicians. The CSCL may act as a liaison between the Clinical Team and these interfacing groups, as necessary, and provide them with critical information on Vaccine Clinical programs including program and regulatory commitment requirements and timelines, therapeutic area expertise, key program messages, and vaccine-specific document requirements, as necessary, to ensure consistency and quality across all clinical documents within a program. ROLE RESPONSIBILITIES
- Provides experienced high-level project management support on a program level for global and regional vaccine clinical communications activities, working in collaboration and as a liaison with relevant functional representatives on a Clinical Team, including but not limited to the Clinical Lead, Study Clinicians, Development Japan, Alliance Partner Clinical Project Manager, Global Product Development Asset Lead, and Medical Documentation and Labelling representative.
- Plans and writes clinical documents that are within the scope of the VCRD group, including but not limited to clinical sections of IMPDs, publications, relevant sections of IND Annual Reports. Provides such support for required clinical document preparation needs for at least one clinical program. This support includes organizing documents, interpreting scientific and statistical data, and writing the documents. Documents must be of high quality, scientifically accurate and be prepared according to timelines of the Clinical Team. Participates in all relevant meetings for document preparation, such as kick-off meetings, and is responsible for soliciting and incorporating reviewer comments. Interfaces with downstream groups such as Document Quality Review and Vaccine Submission Management for data checking and editing, submission-ready checks and document archiving for the documents in scope. Interfaces with clinical document owner group when sections of documents are prepared by CSCL.
- Liaises with writers and document coordinators from other interfacing Pfizer groups that write or coordinate the completion of additional clinical documents, including, but not limited to, Global Product Development/Alliance Partners, Development Japan, Japan Vaccine Research, Medical Documentation and Labeling (MDL), and Worldwide Safety and Regulatory Operations (WSRO). Ensures Vaccine Clinical writing needs are met within the context of the Clinical Project Team, writers in those groups receive appropriate information on the Vaccine therapeutic area and program, and that these groups understand project priorities, required documents, and timelines. Tracks writing requirements within a program, as necessary. Provides and/or coordinates program-level training for interfacing writers, as necessary. Ensures common clinical project verbiage (e.g. style guides) and key messages (e.g. results) are consistent within the program across the multiple documents written by various groups. Ensures consistent document standards are used for all clinical documents within a program.
- Provides preliminary review for Vaccine Clinical Research for documents that are written by clinical writers from groups outside VCRD, as necessary. These documents may include butare not limited to Clinical Study Reports, summary documents for global or regional (e.g. Japan) CTDs, responses to regulatory responses, Basic Results and Pharma Web postings, posters and manuscripts, and clinical sections of aggregated safety documents. Manage the collection, collation, and translation of comments from VCR reviewers to clinical writers in interfacing groups to ensure clarity and efficiency in document review. Ensure that comments from VCRD reviewers are explained to interfacing writers and that all discrepancies within the comments from VCRD reviewers are resolved prior to providing to document writer.
- Provides writing and technical support for manuscripts and posters, as necessary.
- Provides Document Quality Review support to clinical documents as required based on program needs. This support may include documents written by groups outside of VCRD, such as Medical Documentation and Labelling, as requested.
- Provides input on new or revised procedures for clinical document preparation. Provides input into relevant SOPs.
- Provides support to clinical writers from interfacing groups on development of program-specific document templates, appendices, listings, and narratives; provides program support for sending serology listings and CSRs to sites.
- Other tasks as requested.
- PhD (preferably in biological sciences) plus 8+ years or comparable experience (BS plus 12+ years, MS plus 10+ years) preferred.
- Strong background in vaccines or infectious diseases and in clinical research preferred.
- At least 8 years of experience with clinical document writing and preparation for regulatory submissions and/or publication experience preferred.
- Working knowledge of statistics, data analysis and data interpretation.
- Knowledge of regulatory systems and processes in other regions, e.g. Japan.
- Training in clinical research, clinical writing, regulatory affairs/regulations, and computer science applications relevant to the work (e.g. MS Word and working knowledge of submission-ready document templates) preferred.
- Experience with clinical document editing, data quality review, and project management preferred.
- Excellent oral and written communication skills.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.PHYSICAL/MENTAL REQUIREMENTS
Work will be performed at a work station. 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.
Work Location Assignment:FlexiblePfizer 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.