Regulatory CMC Manager / CTD Module 3 (Remote-work)

  • Pioneer Data Systems
  • Remote * (Boston,MA)
  • May 22, 2020

Job Description

Position Details:
Our client, a world leading Pharmaceutical Company in Boston, MA is currently looking for a Regulatory CMC Manager / CTD Module 3 (Remote-work) to join their expanding team.

Job Title: Regulatory CMC Manager / CTD Module 3 (Remote-work)

Duration: 08 months contract, Extendable up to 36 months
Location: Boston, MA

Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
You may participate in the company group medical insurance plan

Remote OR may sit at any client site, manager works in EST but open to candidates in different time zones

Title: Regulatory CMC Manager

Job Description:
Assist in the development of module 3 templates that will enable population by automation tools, and enable structured content management. Knowledge of the Common Technical Document (CTD), such as Module 3 for regulatory documents such as CMC related sections. Must have some knowledge of CMC and structured content. Be prepared to work within data systems and processes related to regulatory submissions. Working with cross collaborative teams and CMC authoring.

Bachelors Degree in Science/Engineering/IT
IT experience/programming experience in context of CMC/Module 3 a plus

Job Requirements:

Top 3 Must Have Skill Sets:
6+ years of regulatory experience
Common Technical Document (CTD) knowledge such as Module 3 (CMC)
data systems and processes related to regulatory submissions

Ideal candidate:
Previous Client experience, Systems knowledge, programming experience

Day to Day Responsibilities:
Work with a team to update module 3 templates to enable automation.

Employee Value Proposition:
Ability to work on a cross functional, high priority team.

Red Flags:
No RA experience