The Expert Regulatory Writer writes, reviews and/or manages high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Provides authoritative documentation-related consultancy to other line functions. Coaches/mentors and/or trains less experienced submission writers.
1.To write, review and/or manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (Briefing Books, answers to questions).
2.Extended member of Clinical Trial Team (CTT) / extended member of Safety Management Team (SMT). Core member of Clinical Submission Team (CST). Extended member of International Clinical Team (ICT).
3.Strategic input into planning of data analyses and presentation (report analysis plan review and meetings) to be used in CSRs, submission documents and/or answers to questions.
4.Documentation expert in ICTs and CSTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD.
5.Program Writer for large programs ensuring adequate medical writing resources are available for assigned program and consistency between documents.
6.Lead Writer for complex submissions to ensure adequate medical writing resources and coordinate production of CTD submission documents by medical writing team. Provide operational and propose strategic direction for submissions.
7.Lead process improvement by taking the lead in DE and cross-functional initiatives and/or activities (e.g. review of SOPs, templates).
8.Identify training needs to foster high level of performance within DE. Coach/mentor and/or train less experienced submission writers.
9.Leader in cross-functional communication to optimize feedback and input towards high quality documents.
10.Maintain audit, SOP and training compliance
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.
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
Fluent English (oral and written).
Experience / Professional Requirement:
6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes.
Excellent communication skills (written, verbal, presentations)
Expert operational and strong strategic knowledge of clinical trial reporting.
Expert knowledge of biostatistics principles.
Proven ability to prioritize and manage multiple demands and projects.
Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs.
Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
Demonstrated ability to define and solve complex problems ( Problem-solver )
Broad knowledge and future oriented perspective
Proven ability to drive and manage organizational and team performance across cultures.
Proven track record in matrix environment
Repeat experience in managing global, cross functional teams or complex global projects.
Demonstrated ability to motivate and coach people.
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.