The role manages and conducts quality reviews to support delivery of accurate, compliant, and submission-ready documents prepared by authors in Medical Writing and other clinical groups. Documents include (but are not limited to) protocols, clinical study reports, disclosure documents, clinical summaries/overviews for marketing applications, briefing documents, regulatory responses and related correspondence and presentation materials.
- With minimal supervision, perform quality reviews and participate to quality projects in accordance with agreed upon timelines.
- Verify accuracy of document content using source documents including clinical regulatory documents (e.g., protocols, clinical study reports, CIOMS reports, clinical summaries/overviews) and data tables, figures, and listings.
- Verify internal consistency within a document and across related documents
- Verify uniformity and compliance of documents with internal and external standards (e.g., document templates, company style guide, publishing requirements).
- Record findings and identify appropriate corrections to address findings.
- Collaborate with document authors and other team members to resolve findings.
- Identify, communicate, and resolve issues impacting document timelines.
- Propose recommendations for process improvements that could reduce recurring errors in documents.
- Participate in quality processes and process improvement initiatives.
- Contribute to the training of colleagues on quality standards and processes.
QUALIFICATIONS / SKILLS
- At minimum Bachelor degree, preferably in a life science discipline. Advanced degree preferred.
- BS/BA +5 years, MS/MA +3 years of experience in document QC and/or medical writing in the pharmaceutical or biotech industry.
- Ability to work with minimal supervision. Ability to work well under pressure and adapt to change as needed.
- General understanding of medical terminology, clinical trials, and drug development process.
- Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
- High degree of fluency in written and spoken English.
- Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
- Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel, MS PowerPoint).
This role can be site or remote based.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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.Medical