1877- Associate Principal Regulatory Writer- Clinical Focus
Company: Certara Inc.
Location: New Haven
Posted on: June 12, 2021
Certara is hiring an Associate Principal Regulatory Writer to
join our Synchrogenix Regulatory Services division!
Certara optimizes R&D productivity, commercial value, and
patient outcomes through its unique portfolio of model-informed
drug development, regulatory science, and market access solutions.
In fact, since 2014, our customers have received over 90% of new
drug and biologic approvals by the FDA.
As Certara's regulatory science division, Synchrogenix, a
Certara company, assures and accelerates regulatory success through
a unique combination of customized regulatory strategy, document
authoring, medical communications and publications, and operations
solutions. Synchrogenix's proven record of success is built on an
unrivaled commitment to quality and compliance combined with the
use of advanced technologies to enhance speed and efficiency.
Position Overview: Clinical Focus
Associate Principal Regulatory Writers are critical members of
Synchrogenix's regulatory services team. They do more than prepare
high-quality documentation for regulatory submissions; they help
streamline the regulatory documentation process and provide
strategic guidance and best practices for our clients. The
Associate Principal Regulatory Writer (APRW) is a significant
contributor to document authorship in various therapeutic areas and
global markets. The APRW will be the project leader and authoring
contributor for all types of client engagements while mentoring
others to authorize regulatory documents.
What we offer:
- Flexibility: The option to work remotely or in one of our
global office locations
- Recognition: Synchrogenix recognizes and celebrates the
extensive experience and expertise our writers bring to regulatory
submissions and product approvals.
- Cutting edge technology: Upskill with advanced technologies
that enhance speed and efficiency
- Collaborative work environment: A team-based, collaborative
approach to regulatory writing provides our writers with the
support they need to deliver the highest quality work.
- Comprehensive benefits: Competitive compensation, incentives,
full benefits, and flexible paid time off (PTO)
Requirements for the Role:
- Bachelor's degree, minimum; advanced degree preferred
- 8+ years of regulatory writing experience with clinical-related
- Deep understanding of global regulatory requirements for
different phases of drug development and different regulatory
- Experience in the development of clinical and submission-level
- Mastery of Microsoft Word skills (editing tools, creating and
modifying tables, and inserting figures) and document management
- Demonstrate an understanding of communication best practices,
coaching others on communication implications of decision
- Ability to resolve problems that arise, particularly in
sensitive or high-pressure situations
- Possesses broad experience and technical expertise across more
than one therapy area and integrate this knowledge to deliver
business successes and actively transfer this knowledge to
strengthen the skill base across the organization
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
status, pregnancy, physical or mental condition, genetic
information, military service, or other characteristic protected by
New Haven, CT
Keywords: Certara Inc., New Haven , 1877- Associate Principal Regulatory Writer- Clinical Focus, Other , New Haven, Connecticut
Didn't find what you're looking for? Search again!