Expert Regulatory Writer

1 month ago

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 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.

**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**
- 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**

**Join our Novartis Network**:
**We are Novartis. Join us and help reimagine medicine.**

**#LI-Hybrid = Novartis**

**Division**
- Global Drug Development

**Business Unit**
- GDO GDD

**Country**
- United Kingdom

**Work Location**
- London-West

**Company/Legal Entity**
- Novartis Pharmaceuticals UK Lt

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

  • Writer - Expert Market

    2 days ago

    London, United Kingdom MVF Full time

    **The Role** Working as part of the Expert Market team, your role will be to conduct research and write high quality, informative content for one of our leading digital brands. This content will attract users interested in the products and services we offer through organic search. As a Writer you will conduct product research, surveys and interviews to...

  • Senior / Principal Regulatory Writer

    4 days ago

    London, United Kingdom Barrington James Full time

    SENIOR MEDICAL WRITER (Germany, UK, USA, Canada, Portugal, Italy, Ireland)nOnly candidates who meet the following requirements will be considered:nCandidate must live in one of the following countries: Germany, UK, USA, Canada, Portugal, Italy, Ireland. Applicants will work from one of our offices (Frankfurt, Germany; Cambridge, UK; Durham, NC, USA) or...

  • Senior Medical Writer

    1 week ago

    London, United Kingdom GEORGE BUCKLAND LIMITED Full time €55,000

    Medical Education Writer – Senior medical education agency – Bucks The editorial and medical writing team, at this Buckinghamshire medical education agency, is the largest team of its kind among similar mid-size agencies. This means that, as Senior Medical Writer, you benefit from excellent personal development opportunities – both through the...

  • Senior Medical Writer

    1 week ago

    London, United Kingdom GEORGE BUCKLAND LIMITED Full time €55,000

    Medical Education Writer – Senior medical education agency – Bucks The editorial and medical writing team, at this Buckinghamshire medical education agency, is the largest team of its kind among similar mid-size agencies. This means that, as Senior Medical Writer, you benefit from excellent personal development opportunities – both through the...

  • Senior Bid Writer

    1 week ago

    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 with...

  • Senior Bid Writer

    1 week 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...

  • Senior Bid Writer

    2 weeks 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

    1 week 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...

  • Medical Writer

    2 months 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...

  • Senior Bid Writer

    1 week 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 weeks 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 weeks 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

    4 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...

  • Freelance Medical Writer

    4 weeks ago

    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...

  • Freelance Medical Writer

    4 weeks ago

    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...

  • Medical Writer

    1 week ago

    London, United Kingdom Cpl Life Sciences Full time

    **Reference Number**: JO-2101-461251 Medical Writer **Rate**: Negotiable **Job Type**: Permanent **Location**: Central London / West End Job Title - Medical Writer Job Number - JO-2101-461251 Location - UK (Remote) Salary - Dependent on experience Regulatory Clinical writer working for a forward thinking regulatory affairs consultancy on a range of...

  • Writer, Investments

    3 days ago

    London, United Kingdom Mason Blake Full time

    Our client is a fast-growing asset management house. Due to continued business success, they are now looking to recruit an Investment Writer to join their high-performing marketing team on a permanent basis. Working directly with the portfolio managers, the Investment Writer will take responsibility for the following duties: Create digital content...

  • Spectrum And Regulatory Affairs Expert

    2 weeks ago

    London, United Kingdom Redline Group Ltd Full time

    My client, who are one of the leading mobile web browsers, is seeking a Spectrum And Regulatory Affairs Expert, to join their team in Surrey. The job's main purpose is to provide expert support to the spectrum strategy and telecoms technology development, the role will have a particular focus on working with ITU, national (Ofcom /ANFR) and regional...

  • Bid Writer

    1 week 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. 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...

  • Bid Writer

    2 weeks 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...