Summary
The Medical Writing Operations Manager is a member of the Medical Writing Quality and Operations team within the global Medical Writing department. The role provides comprehensive, operational expertise in medical writing and vendor quality standards, partnering with internal and external groups to provide operational support, to ensure compliance, and to promote innovation in reporting deliverables.
Job Responsibilities
- Provide guidance to medical writing vendors and project teams on standard processes for preparing safety narratives, plain language study results summaries, and associated deliverables within the scope of Medical Writing. Guidance is based on understanding and knowledge of the underlying operational principles of applicable processes.
- Plan and manage project timelines to ensure that vendors complete deliverables within agreed-upon timelines. and Identify, communicate, and resolve issues affecting project timelines.
- Manage routine vendor interactions, including preparation of work requests, procurement of access to internal systems, and monitoring of training compliance. Attend regular operational governance meetings with vendors. Assist management with forecasting by generating and/or reviewing reports from internal systems.
- Facilitate inspection readiness for processes in SOPs (Standard Operating Procedures)/Work Instructions (WIs) used by Medical Writing. Review documentation in trial master file and other systems associated with the CSR SOP. Respond to document requests before and during inspections. Assist management in the development of responses or corrective actions/preventive actions (CAPAs), as needed.
- Support vendor oversight by collecting and reviewing document quality metric data from vendors.
- Support innovation by supporting workstreams to evaluate technologic solutions to improve operational efficiency of business processes. Suggest moderately complex changes to improve operational efficiency.
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Qualifications
- At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
- BS/BA +5 years, MS/MA +3 years of medical writing or vendor management experience in the pharmaceutical or biotech industry.
- A comprehensive understanding of the drug development process.
Work Location Assignment: Remote - Field Based
#LI-Remote
The annual base salary for this position ranges from $88,300.00 to $147,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Medical