The Senior Medical Writer is a member of the Clinical Communications team within the Medical Writing department. The role collaborates with clinical study teams to plan and prepare protocols, clinical study reports (CSRs), and public disclosure synopses (PDS) that are accurate, compliant, and submission ready. The role completes document deliverables as assigned and may be responsible for managing document deliverables for a single asset.
ROLE RESPONSIBILITIES
• With minimum supervision, write, edit, and format protocols, CSRs, and PDS by organizing, analyzing, and interpreting scientific, clinical, and statistical data. Work closely with study teams to ensure that documents are scientifically accurate, internally consistent, and meet intended purpose. Prepare documents in accordance with internal standards and external regulatory guidelines.
• Develop and maintain document timelines in line with business objectives. Manage writing activities to complete documents within agreed-upon timelines. Identify, communicate, and resolve issues impacting document timelines.
• Drive document preparation process within teams. Engage teams in document planning activities, including review of document shells, safety narrative plans, and mock/draft tables, figures, and listings. Plan and lead document review meetings to achieve consensus on document strategy, content, and format.
• Coordinate documents prepared by other writers as needed.
• Support implementation of reviewer guidelines, process initiatives, and technologic innovations to improve document development process. Suggest changes to document processes or templates to improve quality and/or efficiency. Participate in process initiatives.
QUALIFICATIONS
• At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
• BS/BA +7 years, MS/MA +5 years, PhD +3 years of medical writing experience in the pharmaceutical or biotech industry.
• Solid understanding of the drug development process. Solid knowledge of relevant regulatory guidelines as well as medical and statistical concepts.
• Medical writing experience in protocols and CSRs.
• Ability to work independently. Ability to work well under pressure and adapt to change as needed.
• Excellent project management skills to organize work and handle multiple projects at the same time. Ability to guide teams during document development.
• Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
• Ability to apply relevant knowledge and experience to solve complex problems, using flexibility and persistence as appropriate.
This role can be remote based.
Employee Referral Eligible.
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Sunshine Act
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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.
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