Certara - Medical Writer – Clinical Regulatory Writing (Principal, Associate Principal, Senior) - Remote anywhere in Europe
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 optimise 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,
Certara has global team of ~1000 employees with more than 300 PhD, PharmD, and MD scientists and regulatory writers, working on key drug development projects for biopharmaceutical companies.
We value each and every one of our employees and demonstrate that by offering our employees:
- Opportunity for career advancement that align to your professional goals.
- Collaborative work environment where you will continuously learn and work towards a common goal.
- Competitive benefits and compensation packages that reward your strong performance.
- Genuinely impactful work that will make a difference to the lives of people all over the world
- Flexibility - the option to work remotely or in one of our global office locations.
We look for:
- A high degree of professionalism: Transparency, authenticity, collaboration, respect and accountability.
- A "Growth Mindset"
- A Continuous Learner
- The ability to adapt - we're an ever growing, evolving organisation with ambitious plans. With that comes change and we look for people who can embrace, and contribute to, that journey.
Certara is hiring an Associate Principal Regulatory Writer to join our Synchrogenix Regulatory Services division!
Position Overview: Clinical Focus
Associate Principal Regulatory Writers are critical members of Synchrogenix’s regulatory services team. They do more than prepare high-quality documentation for regulatory submissions; they help streamline the regulatory documentation process and provide strategic guidance and best practices for our clients. The Associate Principal Regulatory Writer (APRW) is a significant contributor to document authorship in various therapeutic areas and global markets. The APRW will be the project leader and authoring contributor for all types of client engagements while mentoring others to authorize regulatory documents.
- Lead project teams and work closely with the client and internal and partner organization teams to develop strategies for organizing and preparing clinical regulatory documents. Duties include:
- Authoring documents per client specifications, templates, style guides, per regulatory authority guidelines and requirements
- Managing the budget for projects, including all contributors (writers, editors)
- Ushering documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
- Lead project-related meetings and teleconferences
- Maintain collaborative, proactive, and effective communication with both client and internal teams
- 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
Requirements for the Role:
- Bachelor’s degree, minimum; advanced degree preferred
- 8+ years of regulatory writing experience with clinical-related documentation
- Deep understanding of global regulatory requirements for different phases of drug development and different regulatory pathways
- Experience in the development of clinical and submission-level documents
- Mastery of Microsoft Word skills (editing tools, creating and modifying tables, and inserting figures) and document management techniques
- Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
- 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 integrate 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.