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For Companies At a Glance
- Tasks: Lead and author regulatory documents for clinical trials, ensuring high quality and compliance.
- Company: Join Certara, a leader in biosimulation software transforming drug discovery and development globally.
- Benefits: Enjoy flexible work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with top professionals in a supportive environment.
- Qualifications: Bachelor's degree required; 8+ years of regulatory writing experience preferred.
- Other info: Opportunity to mentor junior staff and lead projects in a dynamic team setting.
The predicted salary is between 48000 - 72000 £ per year.
Overview
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 Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The APRW 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; MS or PhD preferred
- 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 strength the skill base across the organization
EEO
Certara bases all employment-related decision 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. #J-18808-Ljbffr
R&A - Associate Principal Regulatory Writer - Clinical Focus employer: Certara
Contact Detail:
Certara Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&A - Associate Principal Regulatory Writer - Clinical Focus
✨Tip Number 1
Familiarise yourself with the specific regulatory guidelines relevant to the role. Understanding the nuances of documents like Clinical Study Reports and Clinical Study Protocols will give you an edge in discussions and interviews.
✨Tip Number 2
Network with professionals in the regulatory writing field. Attend industry conferences or webinars where you can meet people from Certara or similar companies, as personal connections can often lead to job opportunities.
✨Tip Number 3
Brush up on your project management skills. Since the role involves leading project teams, demonstrating your ability to manage timelines and budgets effectively will be crucial during the interview process.
✨Tip Number 4
Prepare to discuss your experience with cross-functional teams. Highlighting your ability to collaborate with various stakeholders will show that you can thrive in the collaborative environment at Certara.
We think you need these skills to ace R&A - Associate Principal Regulatory Writer - Clinical Focus
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Associate Principal Regulatory Writer position. Tailor your application to highlight relevant experience in regulatory writing and document authorship.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 8+ years of regulatory writing experience, particularly with clinical sections of the CTD. Provide specific examples of documents you've authored, such as Clinical Study Reports or Protocols, to demonstrate your expertise.
Showcase Communication Skills: Since the role involves client interaction and team leadership, illustrate your strong communication skills in your application. Mention any experience you have in leading project teams, conducting meetings, or coaching junior staff.
Tailor Your Documents: Ensure that your CV and cover letter are tailored to Certara's requirements. Use their terminology and align your experiences with the job description. This shows that you have done your homework and are genuinely interested in the position.
How to prepare for a job interview at Certara
✨Know Your Regulatory Writing
Make sure you have a solid understanding of regulatory writing, especially the clinical sections of the CTD. Be prepared to discuss your experience with documents like Clinical Study Reports and Protocols, as well as how you've navigated regulatory authority guidelines in past projects.
✨Demonstrate Leadership Skills
As an Associate Principal Regulatory Writer, you'll be leading project teams. Highlight your experience in managing projects, facilitating meetings, and resolving conflicts. Share examples of how you've successfully led teams to consensus and delivered high-quality documents on time.
✨Showcase Your Communication Abilities
Effective communication is key in this role. Be ready to discuss how you've built strong relationships with clients and internal teams. Provide examples of how you've communicated complex ideas clearly and effectively, and how you've coached others in best practices.
✨Prepare for Problem-Solving Scenarios
Expect to be asked about how you handle challenges in high-pressure situations. Prepare examples that demonstrate your ability to practice blameless problem-solving and how you've resolved issues while maintaining project timelines and budgets.
