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- Tasks: Lead the development of regulatory documents and strategies for drug approval.
- Company: Join Certara, a leader in drug development and regulatory science.
- Benefits: Competitive salary, full-time role, and opportunities for professional growth.
- Why this job: Make a real impact on patient care by helping develop new therapies.
- Qualifications: Bachelor's degree required; 5-8 years of regulatory writing experience preferred.
- Other info: Collaborative environment with a focus on innovation and career advancement.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the R&A - Associate Principal Regulatory Writer (APRW) - Clinical role at Certara.
Certara (CERT) is the largest and most comprehensive provider of strategic drug development, modeling & simulation and regulatory science services. We partner with biopharmaceutical businesses to optimize drug development decisions and accelerate the drug development process. At Certara, you will play an important role helping our clients develop new therapies and target unmet medical needs, expand the benefits of existing therapies to other populations, communicate scientific information in the language of regulatory success, balance risk profiles, differentiate drugs from a competitive perspective, and unlock millions in R&D savings. Ultimately, you’ll be helping more critical drug products get to more patients.
Responsibilities
- Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents.
- Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents).
- 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 collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result.
- 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 project-related meetings and teleconferences.
- Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.
Qualifications
- Bachelor’s degree; MS or PhD preferred.
- 5-8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD such as: 2.5 Clinical Overview, 2.7 Clinical Summaries, Clinical Study Reports, Clinical Study Protocols, Briefing Documents.
- 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).
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.
- Expertise to provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization.
- Ability to own submission-level sections (e.g., clinical section [Module 2.7]), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects.
- Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making.
- 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.
- Ability to resolve problems that arise, particularly in sensitive or high-pressure situations.
- Possesses broad experience and technical expertise across more than one therapy area and integrates this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization.
EEO
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.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Consulting
Industries: Business Consulting and Services
R&A - Associate Principal Regulatory Writer (APRW) - Clinical employer: Certara
Contact Detail:
Certara Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&A - Associate Principal Regulatory Writer (APRW) - Clinical
✨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 projects. Understand their values and how they align with your skills. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit for the R&A - Associate Principal Regulatory Writer role.
✨Tip Number 3
Practice your pitch! You should be able to clearly articulate your experience and how it relates to the job. We recommend rehearsing with a friend or in front of a mirror to nail down your delivery and make a lasting impression.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show you were engaged and genuinely interested in the role.
We think you need these skills to ace R&A - Associate Principal Regulatory Writer (APRW) - Clinical
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Associate Principal Regulatory Writer role. Highlight your relevant experience in regulatory writing and how it aligns with the responsibilities outlined in the job description.
Showcase Your Skills: Don’t forget to emphasise your proficiency with Microsoft Word and your understanding of the drug development lifecycle. We want to see how your skills can contribute to our team and help us achieve regulatory success.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language and structure your thoughts logically. This will not only make your application easier to read but also demonstrate your writing skills.
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 the Certara 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 relevant to the role. Familiarise yourself with the Clinical Overview, Clinical Summaries, and other key documents mentioned in the job description. This will show that you're not just a writer but someone who understands the intricacies of regulatory writing.
✨Showcase Your Team Leadership Skills
Since the role involves leading project teams, be prepared to discuss your experience in managing teams and projects. Share specific examples where you successfully led a team through the document review process or resolved conflicts during comment resolution meetings. Highlighting your leadership style can set you apart.
✨Demonstrate Effective Communication
Communication is key in this role, so think about how you can demonstrate your ability to build strong relationships with clients and internal teams. Prepare examples of how you've communicated complex ideas clearly and effectively in past roles, especially in high-pressure situations.
✨Be Ready for Problem Solving
Expect questions around problem-solving, especially in sensitive scenarios. Think of instances where you faced challenges in document preparation or project management and how you navigated those issues. Practising blameless problem-solving techniques will show that you can handle pressure while maintaining a positive attitude.
