1+ months

Senior Medical Writer (Senior Manager)

Groton, CT 06340
**Role Summary:**

The Senior Medical Writer collaborates with members of the clinical study team to author protocols and independently interprets study results to prepare high quality clinical study reports (CSRs), public disclosure synopses (PDS) and related clinical documents within agreed-upon timelines.


+ Collaborates with clinicians, statisticians and clinical scientists to author protocols.

+ Independently plans and prepares key clinical documents by organizing, analyzing, and interpreting scientific clinical and statistical data

+ Drives the document preparation process for assigned clinical studies; participates in study team and targeted program team meetings

+ Using knowledge and work experience, reaches consensus with the study team on time frames for deliverables; completes documents according to agreed-upon timelines and follows up with team as needed to meet internal and external timeline commitments to ensure SOP and regulatory compliance

+ Ensures submission ready clinical documents are prepared according to International Conference on Harmonization (ICH) guidelines, other relevant regulatory guidelines, and Pfizer standard processes and guidelines

+ Engages early with team including participation in the review of protocol, mock and/or blinded tables, listings, and figures and narrative planning. Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in the final tables, figures, and listings, and other information sources. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed

+ Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion and post-meeting minutes

+ Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and recommends quality process improvements

+ Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency and productivity; participates in GCTE and department initiatives; develop innovative options to resolve complex problems

**Qualifications (Training, Education** **& Prior Experience):**

+ At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.

+ BS/BA +4 years, MS/MA +3 years of relevant medical writing experience in the pharmaceutical industry, especially writing CSRs in one or more of the therapeutic areas in which Pfizer has products

+ A comprehensive understanding of the drug development process

+ Broad experience managing the medical writing responsibilities associated with multiple studies at various stages

+ Advanced knowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing

+ Ability to work independently with minimal supervision, multi-task and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details

+ Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members

+ Utilizes a balanced approach to problems, using flexibility and persistence as appropriate

+ Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately

This role can be remote based.

**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.



Posted: 2020-08-20 Expires: 2020-10-21

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Senior Medical Writer (Senior Manager)

Groton, CT 06340

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