Medical Writing Quality Reviewer

1 month ago

Chennai, India Pfizer Full time

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

Quality Reviews- With mínimal 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.

Special Assignments/Projects- Participate in quality processes and process improvement initiatives.- Contribute to the training of colleagues on quality standards and processes.

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial 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 mínimal 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.Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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