Job ID274930BRPosition TitleExpert Regulatory Writer (80-100%*)Apply to Job
Job Description
200+ projects in development. 20 major approvals. 20 major submissions. And that’s just in 2018. This is your chance to help reimagine medicine in 2019 and beyond. Novartis is looking for dedicated individuals to join our Regulatory Writing team and contribute to developing our pipeline of drugs and biologics into innovative therapies for our patients worldwide. Read on for details about the role and how you can join a world-class organization at the forefront of the industry and how you can further your career.
In this role, you will write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. You will provide authoritative documentation-related consultancy to other line functions. You will coach/mentor and/or train less experienced writers.
Your responsibilities will include (but are not limited to):
∙ Author, review and/or independently manage high quality clinical and safety documents for health authorities.
∙ Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for) clinical submission documents, contributing to statistical analysis plans and presentation of outputs, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
∙ 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 and cross-functional initiatives and/or activities.
∙ Coach and/or mentor less experienced writers.
Minimum requirements
What you’ll bring to the role:
∙ ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes
∙ Expert knowledge of the global registering of drugs, and extensive experience and demonstrated record of accomplishment of leading complex submissions.
∙ Fluent English (oral and written) and excellent communication skills
∙ Proven ability to prioritize and manage multiple demands, projects and cross-functional teams.
∙ Future-oriented perspective and demonstrated ability to define and solve complex problems.
WHY CONSIDER NOVARTIS?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.DivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
