Regulatory Writer
Ver: 164
Dia de atualização: 17-04-2024
Localização: Basel Basel-Stadt BS
Categoria: R & D Ciência Labor Outro
Indústria: Pharmaceutical Manufacturing
Posição: Associate
Tipo de empregos: Full-time
Conteúdo do emprego
Job Description500! The number of regulatory documents we authored last year. As a Regulatory Writer you will write and review high quality clinical and safety documentation for submission to regulatory authorities.
Location: Basel, Switzerland
Your responsibilities:
Your responsibilities include, but are not limited to:
- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).
- Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.
- Core member of Clinical Trial Team (CTT) / participate in Safety Management Team(SMT).
- Actively participate in planning of data analyses and presentation used in CSRs.
- Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
- Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
- Support the development of RWS through participating in RWS workstreams and other related activities.
- Contribute to development of processes within RWS. May contribute to cross-functional initiatives.
- Fostering cross-functional communication to optimize feedback and input towards high quality documents.
- Maintain audit, SOP and training compliance.
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
- Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- Approximately 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
- Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Knowledge of process for and some experience in global registering of drugs (simple submissions).
- Excellent communication skills (written, verbal, presentations)
- Very good understanding of biostatistics principles.
- Ability to prioritize and manage multiple demands and projects.
https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to
diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Global Drug Development
Business Unit
GCO GDD
Country
Switzerland
Work Location
Basel
Company/Legal Entity
Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
Data limite: 01-06-2024
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