Expert Regulatory Writer

vor 2 Wochen

Basel, Schweiz Novartis Vollzeit

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.

**Location**: Basel, Switzerland #LI-Hybrid

**Your responsibilities**:
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.

**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._

**Minimum requirements**
- 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**:Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:
**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

  • Manager Medical Writer

    vor 3 Wochen

    Basel, Schweiz Veristat Vollzeit

    Description : 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...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Offer regulatory assistance for projects and project teams. - Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Basel, Schweiz LHH Vollzeit

    We have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel. As a Regulatory Affairs Manager, you will be responsible for: - Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) - Lead...

  • Global Regulatory Specialist

    vor 3 Wochen

    Basel, Schweiz Syngenta Crop Protection Vollzeit

    Job 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...

  • Associate Director, Regulatory Affairs

    Vor 3 Tagen

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1710 - Who we are - Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. -...

  • QA Expert

    Vor 3 Tagen

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **Takeda Neuchâtel** **Site de Production Biotech | Biotech Manufacturing Site** Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive...

  • Manager, Regulatory Operations Emea

    vor 4 Wochen

    Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

    **Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...

  • Associate Director, Regulatory Affairs

    vor 1 Woche

    Basel, Schweiz Vectura Vollzeit

    Who we areVectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology, and Fertin Pharma, experts in oral and intra-oral delivery systems.We are driven by the exciting and unique goal of addressing...

  • In Vitro Regulatory Reporting

    vor 4 Wochen

    Basel, Schweiz ITech Consult Vollzeit

    **In vitro regulatory reporting & data manager for New Approach Methodologies (M/F/d) - GxP / project management / stakeholder management / data management and digital workflows / regulatory requirements/environment / English** **Project**: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified In vitro regulatory...

  • Early Development Regulatory Manager

    Vor 4 Tagen

    Basel, Schweiz Manpower Vollzeit

    Mandated by one of our client companies, we are currenlty looking for a Regulatory Affairs Manager. The person in this role works with some independence under limited supervision to provide operational and strategic regulatory leadership for early development (ED) programs. **General information**: - Workload: 100% - Duration: 12 months - Remote work: No,...

  • Director Regulatory Affairs Emerging Markets

    Vor 7 Tagen

    Basel, Schweiz Abbott Laboratories Vollzeit

    **THE POSITION**: This role of is the senior most regulatory role within EPD in the Emerging Market business unit_. _As a leader, the role of the Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to support and partner the business by ensuring the successful development, manufacture and distribution of...

  • Director, Regional Regulatory Strategy, Infectious

    vor 4 Wochen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Head of Regulatory Affairs, Cmc

    vor 4 Wochen

    Basel, Schweiz Barrington James Vollzeit

    Basel, Switzerland - 15-06-2023 - JOB TYPE - Permanent - EMP TYPE - Full-Time - EXPERTISE - Regulatory Affairs - SALARY TYPE - Annually - SALARY - Negotiable Position: Head of Regulatory Affairs, CMC & Drug Substances **Responsibilities**: - Establishing and implementing the corporate Regulatory Affairs and CMC development standard across multiple...

  • Regulatory Manager

    vor 1 Woche

    Basel, Schweiz nemensis ag Vollzeit

    For our customer, we are looking for an** Early Development Regulatory Manager (EDRM).** The EDRM works with some independence under limited supervision to provide operational and strategic regulatory leadership for early development (ED) programs. The EDRM executes the regulatory filings, coordinating planning, submission timelines, responses to HA queries,...

  • Freelancer - Banking Regulatory & Compliance

    Vor 3 Tagen

    Basel, Schweiz KPMG Vollzeit

    **Freelancer - Banking Regulatory & Compliance**: - Unterstütze uns mit deinem Know-how in KYC, AML und Compliance und erhalte die Möglichkeit dein einzigartiges Netzwerk weiter auszubauen.- Zürich - nach Vereinbarung - 100 %, 4-6 Monate **So bringst du KPMG weiter****: - Unterstütze bei KYC, AML und Background Checks - Du gibst Support bei Projekten...

  • Senior Regulatory Science and Strategy Lead

    vor 3 Wochen

    Basel, Schweiz IQVIA Vollzeit

    Overview 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

    vor 1 Monat

    Basel, Schweiz Randstad Remote-Arbeit Freiberufler Vollzeit

    A 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

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Randstad Vollzeit

    A 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...

  • Quality Assurance and Pharmacovigilance Expert

    Vor 3 Tagen

    Basel, Schweiz ALTOGEN AG Vollzeit

    **COMPANY** **ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to...

  • QA Associate

    vor 4 Wochen

    Basel, Schweiz Hobson Prior Vollzeit

    **Salary**: Negotiable**Job type**: Interim/Contract **Location**: Basel, Schweiz **Function**: Quality Assurance, Quality Systems **Posted**:18/04/2024 **Ref**: BBBH25158 - Hi I'm Jacob , I manage this role Please note that to be considered for this role you must have the right to work in this location. *** **Key Responsibilities** - Support a...