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Associate Principal Regulatory Writer - US Locations

Company: Certara
Location: Atlanta
Posted on: October 22, 2019

Job Description:

Position: Associate Principal Regulatory Writer
Location: US Locations

Company Overview: Regulatory and Communications Strategy, Science, and Solutions

As the largest consultancy of regulatory and medical writers in the industry, Synchrogenix is already a well-recognized, multi-disciplined provider of regulatory writing, operations, and communications services. Additionally, our innovative technology platform, which includes both the ClinGenuity Artificial Intelligence (A.I.) engine and the GlobalSubmit portfolio of electronic common technical document (eCTD) and regulatory information management (RIM) software, brings a unique end-to-end solution to our clients with the capability to transform the way we plan, create, deliver, and access and track information all of which is essential to empowering decision-making for various stakeholders who are invested in healthcare research and innovation.

Synchrogenix was founded on the principles of ethical business practices and high-quality work. It is a learning-oriented organization with a strong commitment to the idea that every individual regardless of expertise has something to teach and something to learn.

Our Mission

Providing regulatory and communications strategy, science, and solutions to life science companies worldwide. Our regulatory expertise and innovative technology bridges the full regulatory continuum to propel treatments to the market by meeting the needs of all stakeholders and improving public health outcomes.

Our Vision

To revolutionize global healthcare by delivering transformative and innovative approaches to regulatory and communications strategy, science, and solutions. To build next generation talent, solutions and technology that remove barriers and create efficient pathways to treatment and information. We provide expertise in:

* Regulatory Intelligence, Policy & Strategy

* Synchrogenix s Office of Regulatory Intelligence, Policy and Strategy is comprised of proactive policy drivers focused on efficient planning who provide real-time regulatory insights to guide sponsors through the global regulatory maze by making connections with new precedents and trends to influence outcomes and maximize success.

* Regulatory Communications

* Quality information handling is vital throughout a drug s lifecycle. Synchrogenix provides distinct market offerings that advance and protect ownership, yet support collaboration through customer engagement and transparency.

* Regulatory Operations

* Synchrogenix ensures efficient, timely submissions through software and services solutions that break down barriers between strategy, dossier development and global transmissions. Through experience, expertise, and industry insight, Synchrogenix quickly responds to changes in global regulatory requirements and mandates, thus avoiding common issues that can lead to rejections.

* Global Stakeholder Communications

* Synchrogenix provides expertise and relevant communications to global audiences through services and innovative technology. Our offerings support our clients regulatory compliance, while reducing risk and enhancing potential for market success. These offerings include, but are not limited to: regulatory writing, medical communications, safety/pharmacovigilance, patient engagement, and transparency and disclosure.

* Technology & Innovation

* Synchrogenix delivers interoperable and innovative technologies that support our services and differentiate ourselves in the market. Additionally, Synchrogenix provides strategy and delivery capabilities to implement emerging technology solutions both internally and externally.

Work closely with client, internal, and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
As part of project teams, actively participate in development and writing of high-quality documents, such as CSRs, briefing books, and clinical summaries
Author documents per client specifications, templates, style uides, and other guidance documents
Author documents per regulatory authority guidelines and requirements
Manage overall budget for respective project, including all contributing writers and editors
Usher documents through the review process, conduct comment resolutions meetings (CRMs)
Maintain collaborative, proactive, and effective communication with both client and internal teams
Lead project-related meetings and teleconferences
Provide training of writing staff and ensure compliance with company standard operating procedures (SOPs) and staff training requirements
Adhere to SOPs for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization

Preferred but not required - 8+ years of regulatory writing experience with nonclinical, clinical, CMC, or drug safety related documentation
Ability to synthesize data and present it in a written format
Shown success in Word skills and document management techniques
Understanding of document creation process and ability to lead/own a study level document
Collective experience writing a range of study-level documents in their entirety and able to lead/own a study level document
Strong understanding of the document creation process and of clinical development and study level clinical operations from conceptual study design to final CSR/CTR
Ability to conduct/lead a CRM and successfully lead a project team to consensus
Understanding of regulatory requirements for different phases of development and different regulatory pathways and knowledge of global health authority requirements
Has led the development of one or some types of submission-level documents within the CTD
Ability to provide high-quality customer service and follow-through on all assignments
Professional, personable demeanor

Synchrogenix is proud to be an Equal Opportunity Employer and will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status, or any other characteristic protected by law. Synchrogenix makes reasonable accommodations for disabled employees and applicants. Synchrogenix only employs individuals with the right to work in the country/ies where the role is advertised. We are committed to fostering, cultivating, and preserving a culture of diversity and inclusion. The collective sum of the individual differences, life experiences, knowledge, inventiveness, innovation, self-expression, unique capabilities and talent that our employees invest in their work represents a significant part of not only our culture, but our reputation and achievement.

Keywords: Certara, Alpharetta , Associate Principal Regulatory Writer - US Locations, Advertising , Atlanta, Georgia

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