at Certara USA, LLC in Wilmington, Delaware, United States
Certara Synchrogenix is hiring for our Regulatory Writer Acceleration Residency (RWA Residency). We plan to fill five positions for scientific writers with a focus on drug development (shared between the clinical, nonclinical, and pharmacovigilance disciplines) to join our team on January 10, 2022. This program offers the opportunity to develop skills necessary to specialize in a regulatory writing career. The educational program will teach the skills needed to lead regulatory writing projects while increasing exposure to documents that drive drug development. The ideal candidate will have the opportunity to participate in a mentor-driven training program that accelerates the transition to leading the writing efforts for documents like clinical study reports and investigator's brochures for our clinical residents; nonclinical summaries, pharmacology/toxicology/in vitro/in vivo study reports for our nonclinical residents, and development safety update reports and risk management plans for our Pharmacovigilance residents. Certara Synchrogenix has been a leader in regulatory writing for over 30 years, and we are investing in the next generation of regulatory writers!
Regulatory Writers provide support with the development of high-quality documentation for regulatory submissions to help streamline the regulatory documentation process for our clients. The Regulatory Writer I (RW I) will support senior writers in the creation of a variety of documents across different service lines. The RW I will provide scientific insight and analysis while developing a broad scientific knowledge base in the pursuit of a successful project. As a result, the ideal candidate will likely be asked to complete multiple different assessments to evaluate experience, abilities, and fit.
Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or Senior Regulatory Writer
Author documents or sections of documents per client specifications, templates, style guides, and other guidance documents under the direction of a senior writer
Usher documents through the review process
Participate in project-related meetings and provide meetings minutes to participants
Participate in comment resolution meetings (CRMs), complete appropriate preparation documents, and compile appropriate follow-up responses
Understand and adhere to constraints of budgets and tasks as provided by project leads
Education, Experience, Training, and Knowledge:
Bachelor's degree in Scientific discipline or related field with an interest in regulatory writing
Strong computer skills, including proficiency with MS Office and Microsoft Word functionality in terms of editing tools, creating and modifying tables and inserting figures
Additional Preferred Experiences:
Clinical preference: Master's degree or higher in a scientific related field; Scientific writing background (Major in science/ minor in English); Ideally someone with a Regulatory Sciences master's degree
Nonclinical preference: PhD in pharmacology, toxicology or pharmacokinetics; ideally Pharmaceutical Sciences.
Pharmacovigilance preference: PharmD, RPh, PhD in a scientific discipline
Leadership role within a club or other organization or other type of leadership in college/graduate programs
Experience within the communication field, written or verbal
Skills & Abilities:
Able to adapt to Synchrogenix quality core standards within the first month of employment
Understand the fundamental aspects of communication theory and practice
Communicate clear, concise, and relevant information in an assertive, appropriate business format
Able to work in a collaborative and fast-paced environment and be tolerant of some degree of ambiguity, easily build relationships with others
Solution-driven and detail-oriented, and always seeking new development opportunities to build knowledge and skills
Demonstrate solid time management skills and the ability to execute on project plans, especially under pressure
Show flexibility and versatility to meet project needs as required by deadlines and meet corporate goals and objectives
Remain knowledgeable of changes in the industry and adapt best practices
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... 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.