Responsible for providing medical/scientific review and identifying content inaccuracies for preclinical and/or clinical documents (e.g Summary of Clinical Efficacy, Summary of Clinical Safety and Clinical Overview) comprised of multiple clinical study studies, contained within New Drug Applications (NDA), 120 day Safety Updates and Marketing Authorization Applications (MAA) filed by Novartis Pharmaceuticals to governmental Health Authorities.
1. Assess validity of medical/scientific interpretation described in preclinical and clinical documents provided to governmental Health Authorities and identify deficiencies.
2. For assigned programs supported by Global Submissions, provide independent medical/scientific review of clinical summary documents (such as SCE, SCS and CO) and identify content inaccuracies prior to submission to Health Authorities, e.g.:
a. Verify accuracy (100% review) of all factual statements within summary document text compared to post-text sources cited.
b. Verify numeric accuracy (100% review) of all data cited throughout text and hand derived in-text tables compared to post-text sources cited.
c. Verify appropriateness of all internal/external citations noted within summary document.
3. Develop and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors .
4. Compile comprehensive documents containing discrepancies identified among Clinical QC reviewers (with corresponding factual Evidence ) for each clinical summary document in preparation for resolution meeting; Lead resolution of discrepant findings with Submission Team or author, including documenting and archiving results; drive quality forward in the writing process through participation in draft review meetings.
5. Provide cross-divisional support through quality review of divisional specific documents such as CSRs, CERs, Tabular Listings, etc.
6. Ensure continuous awareness of new governmental guidelines for NDA/MAA registration filings as they are issued and ensure changes are appropriately applied to clinical summary documents (SCE/SCS/CO) effected.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Advanced degree or equivalent education/degree in life science/healthcare is required. Fluent English (oral and written)
8-10 years experience in clinical research with proven proficiency in global clinical development.
Ability to understand, interpret complex medical/scientific data and effectively communicate inaccuracies in clinical summary documents to authors.
Demonstrates strong medical/scientific communications (written)
Proven ability to work independently to deliver clinical summary document discrepant findings within defined timelines (e.g. 4-5 working days).
Previous experience in clinical development of NDA/MAA deliverables with knowledge in world wide regulatory requirements for drug registration (e.g., Common Technical Document)
Solid computer technical skills (Word/Excel/PDF development) and ability to learn new systems quickly.
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