Expert Regulatory Writer

4 weeks ago


West London, United Kingdom Novartis Argentina Full time

Job ID- 365359BR- Mar 03, 2023- United Kingdom**Job Description**:

- 500 The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will be responsible for the development of these 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, Answers to Health Authority Questions) for New Drug Applications (NDA), supplemental NDAs, Marketing Authorization Applications and type II variations.**Your responsibilities**:
Your responsibilities include, but are not limited to:
- To author, review and/or independently manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), complex 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 (CTT) / extended member of Safety Management Team (SMT). 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 RWS and cross-functional initiatives and/or activities.
- Can identify training needs to foster 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**:

- Education: Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- Experience: 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 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. Proven ability to prioritize and manage multiple demands and projects. Broad knowledge and future oriented perspective Proven track record in matrix environment Repeat experience in managing global, cross-functional teams or complex global projects.

**You’ll receive**:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

**Why consider Novartis?**
766 million. That’s how many lives our products touched in 2021. 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 brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
**Imagine what you could do at Novartis**

**We are Novartis. Join us and help reimagine medicine.**

LI-Hybrid = Novartis

Division
- Global Drug Development

Business Unit
- GDO GDD

Location
- United Kingdom

Site
- London-West

Company / Legal Entity
- Novartis Pharmaceuticals UK Lt

Functional Area
- Research & Development

Job Type
- Full Time

Employment Type
- Regular

Shift Work
- No



  • West London, United Kingdom Novartis Full time

    500! The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will be responsible for the development of these 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, Answers to...

  • Senior Bid Writer

    3 days ago


    Crawley, West Sussex, United Kingdom W&P PARTNERS LTD Full time

    Our client, a Renewable Energy Business,are looking for a bid writer to join the team who will be integral in developing high quality bid proposals and working on associated tenders. Roles and Responsibilities of the Senior Bid Writer: Responsible for identifying potential bid opportunities and tenders through market research and industry insights in line...

  • Medical Writer

    2 weeks ago


    London, United Kingdom Life Science People Full time

    As a Senior/Principal Medical Writer you will be in a client-facing role and work closely and collaboratively with the project managers, and health economics, systematic review,and statistics teams to deliver high-quality evidence-based solutions for our clients. Manage own workload, and plan project deliverables and timelines. Work with junior writers...

  • Medical Writer

    2 weeks ago


    London, United Kingdom Life Science People Full time

    As a Senior/Principal Medical Writer you will be in a client-facing role and work closely and collaboratively with the project managers, and health economics, systematic review,and statistics teams to deliver high-quality evidence-based solutions for our clients. Manage own workload, and plan project deliverables and timelines. Work with junior writers...

  • Medical Writer

    4 weeks ago


    London, United Kingdom MMS Holdings Inc Full time

    MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency,and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a...


  • London, United Kingdom Hays Full time

    My client has a position available for a Regulatory/ Clinical Medical Writer to join their team for a 6-month initial contract. As the Regulatory/ Clinical Medical Writer you will provide medical writing services mainly for rare diseases protocols and regulatory submission documents. Similar services may be considered to support the other therapeutic...


  • London, United Kingdom Hays Full time

    My client has a position available for a Regulatory/ Clinical Medical Writer to join their team for a 6-month initial contract. As the Regulatory/ Clinical Medical Writer you will provide medical writing services mainly for rare diseases protocols and regulatory submission documents. Similar services may be considered to support the other therapeutic...

  • Senior Bid Writer

    18 hours ago


    Northgate, West Sussex, United Kingdom W&P PARTNERS LTD Full time

    Our client, a Renewable Energy Business,are looking for a bid writer to join the team who will be integral in developing high quality bid proposals and working on associated tenders. Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity Roles and Responsibilities of the Senior Bid...

  • Senior Bid Writer

    2 days ago


    Crawley, West Sussex, United Kingdom W&P PARTNERS LTD Full time

    Our client, a Renewable Energy Business,are looking for a bid writer to join the team who will be integral in developing high quality bid proposals and working on associated tenders. Roles and Responsibilities of the Senior Bid Writer: Responsible for identifying potential bid opportunities and tenders through market research and industry insights in line...

  • Bid Writer

    2 days ago


    Crawley, West Sussex, United Kingdom W&P PARTNERS LTD Full time

    Our client, a Renewable Energy Business,are looking for a bid writer to join the team who will be integral in developing high quality bid proposals and working on associated tenders. Roles and Responsibilities of the Senior Bid Writer: Build and manage a tender schedule, leading tender reviews and reporting and monitoring tender progress Collaborating with...

  • Content Writer

    4 weeks ago


    London, United Kingdom BMS Performance Full time

    £35000.00 - £50000.00 per annum + flexible working policy - London - Industry: Marketing - Date added: 24/01/2023 **Responsibilities** for the position of Content Writer: - You will support the Content team by researching and writing engaging content that covers regulatory and compliance trends - Writing content to same-day or next-day deadlines - Edit...

  • Senior Medical Writer

    4 weeks ago


    London, United Kingdom X4 Group Full time

    Join an international regulatory consultancy as a Senior Medical Writer and support the Head of Department in creating a broad range clinical and regulatory documents for global submissions. **The Company:** **Senior Medical Writer Responsibilities:** - Create and update regulatory documentation for submission to regulatory authorities according to...

  • Content Writer

    4 weeks ago


    City of London, United Kingdom BMS Performance Ltd Full time

    **Responsibilities** for the position of Content Writer: - You will support the Content team by researching and writing engaging content that covers regulatory and compliance trends - Writing content to same-day or next-day deadlines - Edit and proofread content where necessary, written by other content/copywriters, freelance writers, Product Specialists &...


  • London, United Kingdom X4 Group Full time

    A CRO is looking to grow a medical writing team for a new 12 month project. If you have 40 hours a week to contribute to a big project then read on! - 12 month contract - possible extension. - Full time - 40 hours per week. - Fully remote - available to work from UK/EU. - Flexible pay rate - depending on experience. - Client will offer training. **POSITION...

  • Senior Medical Writer

    4 weeks ago


    London, United Kingdom Stem Graduates Full time

    **Senior Medical Writer - Remote Working Available** **Job Location**: Remote Working or Manchester / London Offices **Job Salary**: Extremely competitive **Job Sectors**:Medical Writing Jobs / PhD Medical Writing / Senior Medical Writing Jobs / Medical Writer **The Client**: Our client is a Scientific Communications Agency, who work with global...


  • London, United Kingdom Pearson Full time

    Subject Matter Expert for Qualification Development Reference: SME/VQ Education Closing date: 06 January 2023 at midnight Pearson is recruiting a Subject Matter Expert for Qualification Development for VQ Education. **ROLE SUMMARY**: **ESSENTIAL**: - Qualified to degree level or equivalent - Experience and understanding of the UK and/or international...


  • London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

    Provide regulatory leadership on the Mental Health Missions operational team, working with Agency partners to accelerate the development of new regulatory and evaluation approaches. - Convene discussions with stakeholders across the system including Mental Health medical product innovators and the regulator and evaluator community to develop relationships,...

  • Senior Medical Writer

    2 weeks ago


    London, United Kingdom Meet Full time

    An independent, global medical communications agency who has won countless awards over the years is looking for a Senior Medical Writer (or experienced Medical Writer) to join their team! As a Senior Medical Writer you will have an important role in the development and delivery of scientifically accurate content for our clients’ projects, helping to...

  • Senior Medical Writer

    2 weeks ago


    London, United Kingdom Meet Full time

    An independent, global medical communications agency who has won countless awards over the years is looking for a Senior Medical Writer (or experienced Medical Writer) to join their team! As a Senior Medical Writer you will have an important role in the development and delivery of scientifically accurate content for our clients’ projects, helping to...

  • Senior Medical Writer

    2 weeks ago


    London, United Kingdom W2O Group Full time

    It's not every day we have a chance to make the world a healthier place—but here, it’s our way of life. Idealistic? Maybe. Deeply pragmatic? Always. Real Chemistry is a global health innovation company that has carved out its space at the intersection between healthcare, marketing and communications, tech, and the people at the heart of it all. It’s...