MedFocus Technical Writer-CMC (2570) in Massachusetts

Job Description:

  • Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports and procedures, as well as any other documents determined to be within the scope of the role; and ensure that project time-lines are met

  • Work cooperatively with colleagues in applicable functions or departments (e.g., R&D;, Process Development, Manufacturing, Supply Chain, Regulatory Affairs, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to ensure achievement of COMPANY objectives relating to the preparation of CMC regulatory submissions and associated activities

  • Experience in writing CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other major geographic areas is desirable

Please send resume to

Job Requirements:

  • Bachelor’s degree required, 2 years technical writing experience

  • Detail oriented and articulate with ability to write in a precise, clear style

  • Excellent communication skills, written and verbal

  • Excellent organization skills

  • Strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgment

  • Proficient in use of Windows environment software with advanced skills in Microsoft Word

Min Salary: $0.00

Max Salary: $0.00

State: MA