Expert Regulatory Writer 3
vor 1 Woche
Job ID- 350062BR- Mar 14, 2023- Switzerland**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.
**WHY NOVARTIS?**
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
Division
- Global Drug Development
Business Unit
- GDO GDD
Location
- Switzerland
Site
- Basel
Company / Legal Entity
- Novartis Pharma AG
Functional Area
- Research & Development
Job Type
- Full Time
Employment Type
- Regular
Shift Work
- No
-
Expert Regulatory Writer
Vor 2 Tagen
Basel, Schweiz Novartis Vollzeit500! 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...
-
Regulatory Writer
Vor 2 Tagen
Basel, Schweiz Novartis Vollzeit500! 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 #LI-Hybrid **Your responsibilities**: Your responsibilities include, but are not limited to: - To author and review high...
-
Manager Medical Writer
Gefunden in: Talent CH C2 - vor 1 Woche
Basel, Schweiz Veristat VollzeitDescription : Manager Medical Writer Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the...
-
Global Regulatory Specialist
Gefunden in: Talent CH C2 - vor 1 Woche
Basel, Schweiz Syngenta Crop Protection VollzeitJob DescriptionDo you have a Master degree or a PhD in Science? Are you looking to grow a new career in the Regulatory field? If so, we have a fantastic and unique opportunity to join Syngenta Global Regulatory Team based in Basel. You will take an active part on the journey aiming to reshape our organization and processes, to maximize the use of regulatory...
-
Regulatory Affairs Director
Vor 4 Tagen
Basel, Schweiz Barrington James VollzeitBasel-Stadt - 30-05-2023 - JOB TYPE - Permanent - EMP TYPE - Full-Time - EXPERTISE - Regulatory Affairs - SALARY TYPE - Annually - SALARY - Negotiable Job Title: Regulatory Affairs Director Department: Regulatory Affairs Hours: Full-time Location: Basel, Switzerland **Summary**: We are seeking a highly qualified individual to join our organization as...
-
Regulatory Affairs Manager
vor 22 Stunden
Basel, Schweiz Lonza VollzeitSwitzerland, Basel - Switzerland, Visp**Randstad Inhouse Services** is looking for a Regulatory Affairs Manager (M/F/d) for **Lonza AG** in Basel (100%). This is a **temporary **position for 12 months with an opportunity for an extension. Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science,...
-
Basel, Schweiz ROCKEN VollzeitWir sind in der digitalen Rekrutierung von Talenten und Experten spezialisiert und zählen alle etablierten Unternehmen aus jeglichen Branchen zu unserern Partnern. Diese sind national sowie international tätig und bieten dem zukünftigen Talent eine spannende Herausforderung. Mit dem Anspruch, die besten Talente zu rekrutieren, beraten wir unsere Partner...
-
Director, Global Regulatory Labeling
Vor 4 Tagen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: Moderna Therapeutics is seeking a Director of Regulatory Labeling to support new and existing programs to be based in Basel or other International Moderna hub. This is a newly created role intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for...
-
Regulatory Affiars Manager
vor 22 Stunden
Basel, Schweiz Pharma-Jobs24 VollzeitWould you like to specifically demonstrate your expertise in the field of pharmaceutical services in a new professional challenge in order to fully exploit your potential? Then take the next step with us! As a specialised personnel service provider, the bruederlinpartner group brings specialists and managers in the field of pharmaceuticals, research and...
-
Regulatory and Start Up Specialist 2
Gefunden in: Talent CH C2 - Vor 7 Tagen
Basel, Schweiz IQVIA VollzeitJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions....
-
Regulatory and Start Up Specialist 2
Gefunden in: beBee jobs CH - Vor 7 Tagen
Basel, Basel-Stadt, Schweiz IQVIA VollzeitJob OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions. German and...
-
QA Expert
Vor 5 Tagen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**QA Expert - Drug Development - 5890 ADA** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a** QA Expert - Drug Development **for **1 year contract** with high possibility of...
-
Senior Regulatory Science and Strategy Lead
Gefunden in: Talent CH C2 - vor 1 Woche
Basel, Schweiz IQVIA VollzeitOverview Individuals joining us are assured of a rewarding and progressive career in life sciences consulting. You’ll have the opportunity to address challenging client issues, across multiple geographies with a hands-on influence in delivering solutions. We operate in a truly multi-cultural, collegial and collaborative work environment that is rich in...
-
Functional Expert eWM, Fiori/UI5
Gefunden in: Talent CH C2 - Vor 5 Tagen
Basel, Schweiz Randstad VollzeitJobdescriptionA leading pharmaceutical company in Basel, Switzerland is looking for a Functional Expert eWM, Fiori/UI5.They are looking for an eWM Functional Expert with experience in Fiori/UI5, especially in the context of the design, implementation and testing of Reports in the eWM/Logistics area. Furthermore, experience in delivering GxP and CSV solutions...
-
Functional Expert eWM, Fiori/UI5
Gefunden in: beBee jobs CH - vor 1 Woche
Basel, Basel-Stadt, Schweiz Randstad VollzeitA leading pharmaceutical company in Basel, Switzerland is looking for a Functional Expert eWM, Fiori/UI5.They are looking for an eWM Functional Expert with experience in Fiori/UI5, especially in the context of the design, implementation and testing of Reports in the eWM/Logistics area. Furthermore, experience in delivering GxP and CSV solutions is an...
-
Functional Expert eWM, Fiori/UI5
Gefunden in: beBee S CH - vor 3 Wochen
Basel, Schweiz Randstad Remote-Arbeit Freiberufler VollzeitA leading pharmaceutical company in Basel, Switzerland is looking for a Functional Expert eWM, Fiori/UI5.They are looking for an eWM Functional Expert with experience in Fiori/UI5, especially in the context of the design, implementation and testing of Reports in the eWM/Logistics area. Furthermore, experience in delivering GxP and CSV solutions is an...
-
Regulatory Affairs Manager
Gefunden in: Talent CH C2 - vor 1 Woche
Basel, Schweiz IQVIA VollzeitThe Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...
-
Junior Master Data Expert-csm
Vor 6 Tagen
Basel, Schweiz Adecco VollzeitWe are seeking a talented Junior Master Data Expert to support our client in global master data management processes for various sites, External Supplier Operations, and Commercial site setups, located in Basel. In this role, you will be responsible for ensuring the accurate and timely preparation and maintenance of master data in the SAP ERP system,...
-
Student Internship in Technical Regulatory Affairs
Gefunden in: beBee S CH - vor 4 Wochen
Basel, Basel-City, Schweiz F. Hoffmann-La Roche AG VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Quality Assurance Specialist
Gefunden in: Talent CH C2 - vor 2 Wochen
Basel, Schweiz NES Global Deutschland GmbH NES Fircroft VollzeitWe have an exciting opportunity for a Quality Assurance Specialist (m/f/d) in Switzerland.TasksManage activities supporting the global release of drug substances, products, and intermediates, including documentation approval, batch record review, investigations resolution, and change control assessment in collaboration with CMOs.Drive QA topics and serve as...