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Regulatory Writer Acceleration Residency-Regulator

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

Job Description

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.

 

Responsibilities:

 

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.        

 

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Job Posting: 843959

Posted On: Sep 13, 2021

Updated On: Oct 13, 2021