Medical Writer
6 days ago
Viatris is a global healthcare company that empowers people to live healthier at every stage of life. We achieve this through our commitment to providing high-quality, trusted medicines and innovative solutions that improve patient health.
Job PurposeThe Deputy Manager - Medical Writing role is responsible for writing and reviewing scientific publications, clinical documents, and regulatory submissions. This role requires collaboration with global teams, external reviewers, and vendors to ensure timely drafting, review, approval, and submission of high-quality documents.
Key Responsibilities- Prepares publication plans for Viatris assets, manuscripts for submission to peer-reviewed scientific journals, abstracts, posters, and slide decks for Congress.
- Prepares protocols, clinical study reports, integrated summaries, investigator brochures, annual reports for regulatory submissions.
- Facilitates document-review meetings and provides comments-consolidated documents for these reviews.
- Leads multiple medical writing projects simultaneously in an international matrix environment.
- Proactively manages and escalates up risks to quality, timelines, and compliance.
- Provides inputs for innovation in processes and quality standards for producing high-quality documents.
- Collaborates with external vendors to ensure high standards for submission documents and services provided.
- Ensures inspection/audit readiness, SOP, and training compliance.
- Aligns with the organizational initiatives, standards of performance, and behavior by identifying and working on strengths and improvement areas.
The ideal candidate will have a Master's degree in a relevant field and 8-10 years of experience in medical writing. Certification of CMPP and BELS is an added advantage. The candidate should have a strong understanding of drug development, scientific research, and pharmaceutical environment, as well as ICH, FDA, and ICMJE requirements.
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