Technical Editor, Regulatory Affairs

Company: Harmony Biosciences
Location: Plymouth Meeting
Posted on: January 26, 2025

Job Description:

Harmony Biosciences is recruiting for a Technical Editor, Regulatory Affairs in our Plymouth Meeting, PA location. In this role you will be accountable for technical editing of high-quality regulatory documents across the clinical development portfolio at Harmony. This includes, but is not limited to, copyediting and pre-publishing checks of all documents that are part of a regulatory submission. Additional responsibilities will include support of the electronic document management system (EDMS) ClinicalTrials.gov postings. Responsibilities include but are not limited to:

• Manages all technical aspects of regulatory documents including, but not limited to, Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Statistical Analysis Plans, Investigational New Drug (IND) submission documents, IND Annual Reports, New Drug Application documents, and Investigator Brochures
• Copyedits assigned documents, applying correct grammar, punctuation, spelling, formatting, and style
• Performs data integrity review of assigned documents to ensure accuracy
• Reviews documents for content consistency across submission documents
• Manages quality control workflow with outside MW and QC vendors
• Supports maintenance of document standards, including templates, style guide, drug-specific libraries of standard content, editing checklists, and best practice guides
• Supports department leadership in development and maintenance of department SOPs
• Assists with management of review schedules across multiple projects
• Supports ClinicalTrials.gov postings
• Offers solutions and proactive measures to address document quality findings
• Manages reference library
• Supports internal review process (i.e., PleaseReview)
• Sets standard of excellence for self and others
• Perform other duties as assigned Qualifications:
  • Bachelor's degree required
  • 3+ years technical editor experience in the pharmaceutical industry is required
  • Knowledge of electronic document management systems (EDMS), regulatory documents and regulatory filing processes
  • Strong organizational and time management skills
  • High ethical & quality standards lived through actions and communication
  • Ability to function independently while simultaneously covering multiple project responsibilities in a fast-paced environment Physical demands and work environment:
  • While performing the duties of this job, the noise level in the work environment is usually quiet.
    • Specific vision abilities required by this job include: Close vision.
    • Manual dexterity required to use computers, tablets, and cell phone.
    • Continuous sitting for prolonged periods. What can Harmony offer you?
      • Medical, Vision and Dental benefits the first of the month following start date
      • Generous paid time off and Company designated Holidays
      • Company paid Disability benefits and Life Insurance coverage
      • 401(k) Retirement Savings Plan
      • Paid Parental leave
      • Employee Stock Purchase Plan (ESPP)
      • Company sponsored wellness programs
      • Professional development initiatives and continuous learning opportunities
      • A certified Great Place to Work for seven consecutive years based on our positive, values-based company culture Want to see our latest job opportunities? Follow us on ! Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Keywords: Harmony Biosciences, East Orange , Technical Editor, Regulatory Affairs, Advertising , Plymouth Meeting, New Jersey