Expert Regulatory Writer *3

Closing date
Apr 1, 2023

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Pharmaceutical, Regulatory Affairs
Full Time
Organization Type
Jobseeker Type
Job Description

500! The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies, ranging from Phase I to IV Clinical Study Reports to regulatory submission documents (e.g. Clinical Summaries, Clinical Overview, Briefing Books, answers to Health Authority Questions) for New Drug Applications (NDA), supplemental NDAs, Marketing Authorization Applications and Type II variations.

Your responsibilities include, but are not limited to:
• To author, review and lead high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), complex Common Technical Document (CTD) submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions).
• Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
• Ad-hoc member of Clinical Trial Team and extended member of Safety Management Team. Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT).
• Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
• Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD. Maintain audit, SOP and training compliance.
• Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents.
• Lead process improvement in Regulatory Writing and Submissions (RWS) and cross-functional initiatives and/or activities.
• Can identify training needs to develop high level of performance within RWS. Coach and/or mentor less experienced writers & lead in cross-functional communication to optimize feedback and input towards high quality documents.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Minimum Life Science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
• 6 + years regulatory writer and or medical writer experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus experienced knowledge of medical writing processes.
• Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs.
• Expert knowledge of biostatistics principles.
• Excellent communication skills (written, verbal, presentations). Fluency in English is essential.
• Shown ability to prioritize and lead multiple demands and projects.
• Experience in leading global, cross-functional teams or complex global projects.
• Demonstrated ability to motivate and coach people.

743 million lives were touched by Novartis medicines in 2021 with 21 major drug approvals (US, EU, Japan, China), and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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