Description

Assuring Regulatory Success
Synchrogenix, a Certara company assures and accelerates the approval of and access to medical innovations through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. Our 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.

For more information, please visit www.Certara.com/synchrogenix.

Company Representative

Demetrius Carter, MBA, PMP, RAC-US, CLSSGB
Senior Vice President, Services Operations, Regulatory Services, 919-852-4683

Corporate Collateral

Job Postings

  • As a medical writer, you understand that regulatory submission documents can make or break a drug development program. If you’re ready to work on a variety of challenging clinical projects across therapeutic areas, then it’s time to make a change to Synchrogenix, a Certara company. Join our global team of clinical regulatory writers who share an unrivaled commitment to quality and compliance.
  • Do you have a passion for leading regulatory submissions? Do you find purpose in helping assure and accelerate the approval of medical innovations to patients? If the answer is yes, we have the role for you. We’re looking for global submissions directors with experience in leading and writing INDs, NDAs, and MAAs. Be an integral part of product approvals.
  • The Associate Director, Regulatory Program Management collaborates with the regulatory and submission leads for our regulatory consultation and submission level services, in addition to supporting client lead activities in support of client programs across multiple assets. This individual will serve as the “project manager” across multiple clients and have the capability of tracking milestones as well as helping the clients and client leads navigate the global landscape.