Expert Regulatory Writer
Expert Regulatory Writer
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Job Description
Job Description Summary
#LI-HybridLocation: London (The Westworks) United Kingdom (12 days per month on-site)
Are you passionate about crafting clear impactful clinical and safety documentation that drives regulatory success Were looking for a skilled and experienced Medical Writer to lead the development of high-quality submissions that support global marketing this pivotal role youll provide expert guidance across cross-functional teams mentor emerging talent and ensure excellence in every document delivered.
Job Description
Major accountabilities:
Authorreview and/orindependently managehigh-quality clinical and safety documents including: Complex Clinical Study Reports (CSRs) Protocols Concept Sheets and Informed Consent Forms (ICFs) Complex CTD submission documents (e.g. Clinical Overviews Summaries of Clinical Efficacy and Safety Clinical Pharmacology and Biopharmaceutics) Other regulatory documents (e.g. Briefing Books responses to Health Authority questions).
Leadwriting teams for complex submissionscontributeto key messaging and pooling strategy andprovideexpert guidance on clinical content within the CTD.
Ensuredocumentation complies with internal standards and external regulatory guidelines.
Inputinto planning and presentation of data analyses includingreviewingstatistical analysis plans andparticipatingin relevant meetings.
Actas documentation expert within Global Clinical Teams (GCTs) and Clinical Submission Teams (CSTs).
Providestrategic and content expertise for clinical sections of the CTD.
Reporttechnical complaints adverse events or special case scenarios related to Novartis products within 24 hours of receipt.
Distributemarketing samples where applicable.
Essential Requirements:
University life science degree or equivalent.
Fluent in English (oral and written).
Proficient in medical writing or other relevant pharmaceutical industry roles with strong scientific and regulatory knowledge and deep understanding of medical writing processes.
Expert knowledge of global regulatory environments and processes including key regulatory bodies core submission documents approval pathways and safety reporting requirements.
Proven expertise and successful track record in global drug registration.
Exceptional communication skills written verbal and presentation.
Strong understanding of biostatistics principles and their application in regulatory documentation.
Demonstrated ability to manage multiple priorities and projects effectively in a fast-paced environment.
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Clinical Research Clinical Trials Detail-Oriented Medical Writing People Management Regulatory Compliance Safety Waterfall ModelEmployment Type
Full-Time
