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Regulatory Writer II- PV focus

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

Job Description

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

In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:

informed decision-making & reduced clinical trial burden

higher R&D productivity

improved patient outcomes & increased patient access to medicines

accelerated regulatory approval

Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.

Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.

Synchrogenix, a Certara Company: Achieving Regulatory Success

As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.

Synchrogenix's people are at the core of our success, and our most successful people are:

collaborative and value being part of a team

experts with a thirst for continued learning

consultative with an ability to articulate process and expertise

deadline-driven and able to operate in a fast-paced environment

Job Overview:

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Regulatory Writer II (RW II) is a major contributor to document authorship in support of senior writers in the creation of a variety of documents across different service lines. The RW II may serve as backup project lead, having written sections of regulatory documents.

Responsibilities:

Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or Senior Regulatory Writer

Author documents per client specifications, templates, style guides, and other guidance documents

Review a variety of documents (including but not limited to clinical and pharmacovigilance documents)

Lead project-related meetings; lead a pharmacovigilance document development, understand how the budget affects the tasks and how resourcing works

Maintain collaborative, proactive, and effective communication with both client and internal teams

Lead a comment resolution meeting (CRM) with little support, 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

1-3+ years of regulatory writing experience or equivalent experience

Knowledge of a range of documents (some examples: investigator's brochures, protocol, CSR, pharmacokinetic reports, observational and non-interventional reports, method validation reports, stability reports, development safety update reports, risk management plans)

Possess an understanding of the drug development process

Possess technical regulatory knowledge to understand client technical requirements and needs

 

Skills & Abilities:

Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques

Understand the fundamental aspects of communication theory and practice; demonstrate an understanding of analyzing data and presenting in a written format.

Effectively build support and consensus in support of a quality work product

Communicate clear, concise, and relevant information in a professional manner

Ability to work in a collaborative environment, openly share information, and willingly contribute toward accomplishment of team goals

Action and detail oriented, always seeking new development opportunities to... 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: 844575

Posted On: Sep 15, 2021

Updated On: Oct 03, 2021