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For Companies At a Glance
- Tasks: Lead the creation of regulatory documents for clinical trials and submissions.
- Company: Join Certara, a leader in biosimulation software transforming drug discovery globally.
- Benefits: Enjoy flexible work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by streamlining drug approvals and collaborating with top professionals.
- Qualifications: Requires a Bachelor's degree and 10+ years of regulatory writing experience.
- Other info: Work with diverse teams and develop strong client relationships in a supportive environment.
The predicted salary is between 48000 - 72000 £ per year.
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The PRW 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.
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 (minimum).
- 10+ years of regulatory writing experience with clinical-related documentation.
- Understands regulatory requirements for different phases of development and different regulatory pathways.
- Knowledge of global health authority requirements.
- Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance).
- Strong understanding of the document creation process and of the drug development lifecycle.
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 (clinical documents, e.g., Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE), 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.
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 - Principal Regulatory Writer (PRW) - Clinical Focus employer: Certara
Contact Detail:
Certara Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&A - Principal Regulatory Writer (PRW) - Clinical Focus
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for clinical documentation in your target therapeutic areas. Understanding these nuances will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory writing field, especially those who have experience with Certara or similar companies. Engaging in conversations can provide insights into the company culture and expectations, which can be invaluable during the interview process.
✨Tip Number 3
Prepare to discuss your experience with leading project teams and managing budgets. Be ready to share specific examples of how you've successfully navigated complex projects, as this is a key responsibility for the Principal Regulatory Writer role.
✨Tip Number 4
Brush up on your Microsoft Word skills, particularly in document management techniques. Being proficient in editing tools and creating tables will be crucial, so consider doing a quick refresher course if needed before your interview.
We think you need these skills to ace R&A - Principal Regulatory Writer (PRW) - Clinical Focus
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and qualifications required for the Principal Regulatory Writer position. Familiarise yourself with the types of documents you will be expected to author and the regulatory guidelines that apply.
Tailor Your CV: Customise your CV to highlight your relevant experience in regulatory writing, particularly in clinical documentation. Emphasise your understanding of regulatory requirements and your ability to lead projects and teams.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory writing and your experience in the biopharmaceutical industry. Mention specific projects where you have successfully led document development and how you have built strong client relationships.
Showcase Your Skills: In your application, clearly demonstrate your proficiency with Microsoft Word and document management techniques. Provide examples of how you have synthesised data from multiple sources to create high-quality regulatory documents.
How to prepare for a job interview at Certara
✨Know Your Regulatory Writing Basics
Make sure you have a solid understanding of regulatory writing principles and the specific requirements for clinical documents. Brush up on your knowledge of global health authority guidelines, as this will be crucial in demonstrating your expertise during the interview.
✨Showcase Your Project Leadership Skills
Be prepared to discuss your experience leading projects and teams. Highlight specific examples where you successfully managed document creation processes, resolved issues, and maintained effective communication with clients and team members.
✨Demonstrate Your Problem-Solving Abilities
Prepare to share instances where you practiced blameless problem-solving. Discuss how you approached challenges in previous roles, particularly in high-pressure situations, and what strategies you employed to ensure successful outcomes.
✨Emphasise Your Collaborative Approach
Since the role involves working closely with clients and internal teams, be ready to talk about how you build and maintain professional relationships. Share examples of how you've fostered collaboration and trust in past projects to achieve common goals.
