Deputy Manager
3 weeks ago
About Viatris
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
- Access – Providing high quality trusted medicines regardless of geography or circumstance.
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Deputy Manager- Medical Writing role, will make an impact:
Role Purpose
The Senior Medical Writer (SMW) is responsible for writing and reviewing scientific publications, clinical documents, critical regulatory documents/submissions, and other essential documentation. SMW will ensure timely drafting, review, approval and submission of high quality documents while collaborating with global teams (like Medical Leads, Clinical development, Biostatistics, ClinPharm, Safety, Regulatory, etc) , external reviewers and vendors. SMW may be required to assist senior staff in the development and implementation of departmental processes and guidelines.
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.
Performs other duties as requested by management.
Supervisory/Management Responsibilities
- No supervisory responsibility
Position Accountability Scope
Scope of the role Global
Own: Global Medical Writing
Influence: Global medical-country medical-clinical development
Qualification and Experience
- Medical Writing experience of 8-10 years
- Master’s degree preferred.
- Doctorate degree would be an added advantage.
- Certification of CMPP and BELS would be an added advantage.
Understanding of Drug development, scientific research, pharmaceutical environment
ICH, FDA and ICMJE requirements
Level of English proficiency required for this role: Advance
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