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CMC Writer

Camargo Pharmaceutical Services LLC


Location:
Cincinnati, OH or Durham, NC, Ohio 45241
Date:
06/24/2018
2018-06-242018-08-23
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Materials/Logistics
Camargo Pharmaceutical Services LLC
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Job Details

Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes. As CMC Writer, you will work with our Scientific and Research Services team to assist and guide in the research, writing, and editing of scientific, medical, commercial, and regulatory research documentation as needed for communications with Sponsors and Regulators, and other necessary documents for project assignments. 

 Who you are:

  • You are creative and driven, with an interpersonal savvy that allows you to develop lasting relationships with internal and external stakeholders
  • You are detail-oriented and thorough and know how to drive process both upstream and downstream
  • You are results oriented and possess a strong sense of urgency
  • You are a great teammate and figure out ways to help
  • You have a strong “can do” attitude with genuine commitment to customer service

Requirements

Key Accountabilities & Deliverables:

  • Prepares regulatory documents such as meeting request documents, meeting package documents, IND, and NDA documents.
  • Assists with the writing of comparability protocols, development reports, master batch records, compounding procedures and establishes finished product and in-process specifications.
  • Assists with the management of contract formulators, scientists and testing labs. Establishes standards, quality control and metrics criteria. Assists with testing plans and monitors testing of formulations and products in vitro or in vivo.
  • Participates in meetings between the Sponsor and the FDA in support of the CMC discussion with the Agency. 

Requirements:

  • BS in Pharmacy, Chemistry, Biochemistry or related field.  Master’s Degree preferred. 
  • A minimum of 3 years of CMC experience is required.
  • Direct regulatory experience in the preparation of CMC documents such as INDs, NDAs, and Requests for Information.
  • Demonstrated knowledge of cGMP requirements and FDA regulations and guidance documents.
  • Demonstrated knowledge of the research process and strategic understanding to position drug development programs and client projects. 
  • Demonstrated ability to manage multiple projects/tasks/priorities.
  • Ability to work collaboratively in a team environment, including global companies and sponsors.

About Camargo Pharmaceutical Services:

We are a fast growing, global organization with a small company feel, comprised of high performing, multi-disciplinary, collaborative teams.  We value independent thinking, learning and development (both personally and professionally), and provided the needed resources for you to reach your potential and goals.  Camargo partners with companies in more than 25 countries worldwide and has led the largest percentage of 505(b)(2) submissions of any team submitting to the FDA — Camargo is the industry authority in 505(b)(2). Routinely holding three to six pre-IND meetings a month, Camargo has guided more than 200 FDA approvals and works with product developers across more than 25 countries.

 **This position can be based out of our Cincinnati, OH or Durham, NC office.

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