Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead and author regulatory documents to streamline drug approval processes.
- Company: Join Certara, a global leader in life sciences with a diverse culture.
- Benefits: Competitive salary, inclusive environment, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by transforming drug discovery and development.
- Qualifications: Bachelor's degree and 3+ years of regulatory writing experience required.
- Other info: Collaborative team atmosphere with excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 £ per year.
At Certara, we accelerate medicines to patients by partnering with life science innovators. Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement. Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines. The SRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. Certara is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals.
Responsibilities
- Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor, working with all parties to lead development of strategies for organizing and preparing regulatory documents
- Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
- Manage budget for a low complexity project, including all contributors (writers, editors)
- Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus
- Maintain collaborative, proactive, and effective communication with both client and internal teams
- Lead or participate in project-related meetings and teleconferences
- Provide coaching to junior staff for study level documents
Qualifications
- Bachelor's degree
- 3+ years of regulatory writing experience or equivalent experience with clinical related documentation
- Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
- Experience in the development of submission-level documents (does not require functioning as a document lead)
- Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE
Skills & Abilities
- Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
- Strong understanding of the document creation process and of the drug development lifecycle
- Able to synthesize data across multiple data sources and documents to create summary reports
- Ability to conduct/lead a CRM and successfully lead a project team to consensus
- Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others
- Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
- Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in performance
Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
R&A- Senior Regulatory Writer- SRW (Clinical focus) in London employer: Certara
Contact Detail:
Certara Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&A- Senior Regulatory Writer- SRW (Clinical focus) in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Certara or similar companies. A friendly chat can open doors and give you insider info on job openings.
✨Tip Number 2
Prepare for interviews by practising common questions related to regulatory writing. We recommend role-playing with a friend or using online resources to get comfortable discussing your experience and skills.
✨Tip Number 3
Showcase your expertise! Bring along samples of your previous work or case studies that highlight your regulatory writing skills. This will help you stand out and demonstrate your value to potential employers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace R&A- Senior Regulatory Writer- SRW (Clinical focus) in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Regulatory Writer role. Highlight your relevant experience in regulatory writing and how it aligns with the job description. We want to see how you can contribute to our team!
Showcase Your Skills: Don’t forget to emphasise your skills in document creation and your understanding of regulatory guidelines. Mention any specific projects where you've led teams or managed budgets, as this will show us you're ready for the responsibilities of the role.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language and structure your documents well. This reflects your writing skills and makes it easier for us to see your qualifications at a glance.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team!
How to prepare for a job interview at Certara
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory guidelines and requirements. Familiarise yourself with the specific documents you'll be expected to author, like Clinical Study Reports and Investigator Brochures. This knowledge will not only help you answer questions confidently but also show that you're genuinely interested in the role.
✨Showcase Your Leadership Skills
As a Senior Regulatory Writer, you'll be leading projects and teams. Prepare examples of how you've successfully led projects in the past, especially in a clinical setting. Highlight your ability to manage budgets and coordinate with various contributors, as this will demonstrate your readiness for the responsibilities of the role.
✨Practice Blameless Problem Solving
Certara values a collaborative approach to problem-solving. Think of instances where you've resolved issues without placing blame, focusing instead on solutions. Be ready to discuss how you can apply this mindset in a team environment, especially when navigating complex regulatory challenges.
✨Communicate Effectively
Effective communication is key in this role. Prepare to discuss how you've maintained proactive communication with clients and internal teams in previous positions. You might even want to practice leading a mock comment resolution meeting to showcase your skills in guiding discussions and reaching consensus.
