Harmony Biosciences is hiring: Technical Editor, Regulatory Affairs in Plymouth

3 days ago Requisition ID: 1421

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
• 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