Associate Principal Regulatory Writer- Clinical Fo

at Certara USA, LLC in Wilmington, Delaware, United States

Job Description

At Certara, we accelerate medicines to patients by partnering with life science innovators.

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,
Certara has global team ~1000 employees with more than 300 PhD, PharmD, and MD scientists and regulatory writers, working on key drug development projects for biopharmaceutical companies.
Our Employees Enjoy:
Opportunity for career advancement that align to your professional aspirations.
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

Job Overview:
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of documents across different service lines. The APRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.

* 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

Education, Experience, Training, and Knowledge:
* Bachelor's degree
* 8+ years of regulatory writing experience with clinical- related documentation
* Understand regulatory requirements for different phases of development and different regulatory pathways
* Knowledge of global health authority requirements
* Experience in the development of submission-level documents

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... For full info follow application link.

Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.        

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Job Posting: 976217

Posted On: May 23, 2022

Updated On: Jun 23, 2022