Submission/regulatory Medical Writer
Novartis Healthcare Pvt. Ltd.
1. To author and review independently or assist senior writers in the team to manage high quality clinical and safety documents: Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registry Database (CTRD), Risk Management Plans (RMP), CTD summaries and other special safety/clinical reports.
2. Assist/Lead outsourced Narrative projects. Assist/ Coordinate other outsourced activities.
3. Member of Clinical Trial Team (CTT)/ participate in Safety Management Team (SMT).
4. Actively participate in planning of data analyses and presentation to be used in study reports or summary documents.
5. Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
6. May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
7. Act as liaison between Clinical Trial Teams, Clinical Submission Teams and publishing teams to ensure timely delivery of final documents for publishing.
8. Support the development of the team through participation in initiatives, training/mentoring and other related activities.
9. Contribute to development of processes and may contribute to cross-functional initiatives.
10. Fostering cross-functional communication to optimize feed-back and input towards high quality documents.
11. Maintain audit, SOP and training compliance.
Key Performance Indicators (Indicate how performance for this role will be measured)
1. Delivery of high quality clinical and safety documents in accordance with standard processes with respect to timelines and in compliance with internal and external standards.
2. Completion of an adequate number of documents (taking into account complexity) per year.
3. Adequate representation on the clinical team or submission team, and effectiveness of communication and guidance.
4. Appropriate communication of project resource needs and status.
Ideal Background (State the preferred education and experience level)
Education:
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
Masters with 1-8 years of relevant experience.
PhD or degree in medicine (MBBS/MD or Alternative medicine) with 1-8 years of relevant experience.
Languages: Fluent English (oral and written).
Experience / Professional Requirement: 1 year medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
Excellent communication skills (written, verbal, presentations)
Operational knowledge of clinical trial reporting.
Understanding of biostatistics principles.
Ability to prioritize and manage multiple demands and projects.
Knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
Ability to define and solve complex problems (Problemsolver)
Proven track record in matrix environment
Experience in contributing to global, cross functional projects.
Global, cross-cultural perspective and customer orientation.
Company Profile:
Novartis Healthcare Pvt. Ltd.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
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