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- 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: Full-time role with opportunities for professional growth and development.
- Why this job: Make a real impact in the healthcare industry by accelerating medicines to patients.
- Qualifications: Bachelor’s degree and 3+ years of regulatory writing experience required.
- Other info: Collaborative environment with a focus on mentorship and career advancement.
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. 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 using 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 resolution 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
- 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
- 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) 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)
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with yours. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit for the Senior Regulatory Writer role.
✨Tip Number 3
Practice your storytelling skills! Be ready to share specific examples of your past experiences that highlight your regulatory writing expertise. We believe that showcasing your journey can make a lasting impression on 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 and take the initiative to connect with us directly.
We think you need these skills to ace R&A- Senior Regulatory Writer- SRW (Clinical focus)
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 clinical regulatory writing and how it aligns with what we’re looking for at Certara.
Showcase Your Skills: Don’t forget to emphasise your proficiency with Microsoft Word and your understanding of the document creation process. We want to see how your skills can contribute to our team and help streamline the regulatory approval process.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language and structure your thoughts logically. This reflects the kind of communication we value at Certara, especially when dealing with clients.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows your enthusiasm for joining our diverse and inclusive team at Certara.
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 working on, like Clinical Study Reports and Investigator Brochures. This will show that you're not just a writer, but someone who understands the whole process.
✨Showcase Your Leadership Skills
As a Senior Regulatory Writer, you'll need to lead projects and teams. Prepare examples of how you've successfully managed projects in the past, especially those where you had to interface directly with clients. Highlight your ability to guide discussions and reach consensus during comment resolution meetings.
✨Demonstrate Effective Communication
Communication is key in this role. Be ready to discuss how you've maintained proactive communication with both clients and internal teams. Think of specific instances where your communication skills helped resolve issues or improve project outcomes.
✨Prepare for Problem Solving
Expect questions about how you handle challenges. Practice blameless problem-solving scenarios where you took a broad perspective to prevent negative impacts on your work. Show that you can think critically and creatively when faced with obstacles.
