Harmony Biosciences LLC is hiring: Technical Editor, Regulatory Affairs in Plymo

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 BrochuresCopyedits assigned documents, applying correct grammar, punctuation, spelling, formatting, and stylePerforms data integrity review of assigned documents to ensure accuracyReviews documents for content consistency across submission documentsManages quality control workflow with outside MW and QC vendorsSupports maintenance of document standards, including templates, style guide, drug-specific libraries of standard content, editing checklists, and best practice guidesSupports department leadership in development and maintenance of department SOPsAssists with management of review schedules across multiple projectsSupports ClinicalTrials.gov postingsOffers solutions and proactive measures to address document quality findingsManages reference librarySupports internal review process (i.e., PleaseReview)Sets standard of excellence for self and othersPerform other duties as assignedQualifications : Bachelor's degree required3 years technical editor experience in the pharmaceutical industry is requiredKnowledge of electronic document management systems (EDMS), regulatory documents and regulatory filing processesStrong organizational and time management skillsHigh ethical & quality standards lived through actions and communicationAbility to function independently while simultaneously covering multiple project responsibilities in a fast-paced environmentPhysical 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 dateGenerous paid time off and Company designated HolidaysCompany paid Disability benefits and Life Insurance coverage401(k) Retirement Savings PlanPaid Parental leaveEmployee Stock Purchase Plan (ESPP)Company sponsored wellness programsProfessional development initiatives and continuous learning opportunitiesA certified Great Place to Work for seven consecutive years based on our positive, values-based company cultureWant to see our latest job opportunities? Follow us on LinkedIn !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.#LI-Hybrid