Senior Clinical Editor

Clinical Waltham, Massachusetts


Description

This is one of the most exciting times at Apellis. Especially in Clinical Operations.  Our growing Medical Writing team is seeking an experienced Clinical Editor that will bring editing expertise along with an ability and desire to help develop and build our processes and tools during this growth phase. 

Position Summary:

The Senior Clinical Editor is a key member of our Medical Writing team.  This person will play an instrumental role in building out a standard process for the quality verification, editing, and finalization of  clinical and regulatory documents.  Responsibilities will also include managing, scheduling, and/or performing quality reviews and editing clinical documents, regulatory submissions, medical/scientific publications, and other related documents. 

Key Responsibilities Include:

  • Responsible for implementing and maintaining Apellis QC process standards and templates
  • Performs detailed QC review checks of clinical and regulatory documents, tables, publications, annual reports, literature summaries, submission sections, and internal documents.
  • Proofreads or substantively edit documents to correct and streamline grammar, spelling, style, and format.
  • Verify content is consistent with internal, client, and related authority guidelines.
  • Formats, styles, and troubleshoots functionality and presentation of documents and templates.
  • Assist writers or other team members with supportive tasks (eg, tracking documents) as requested.
  • Assist with literature searches, reference management, bibliographies, and libraries.

Education, Registration & Certification:

  • Bachelor’s Degree

Experience:

  • At least 5 years prior experience in the pharma/biotech industry is required, with at least 2 years in clinical editing

Skills, Knowledge & Abilities:

  • Experience in QC of clinical and regulatory documents within the pharmaceutical/biotech industry
  • Ability to interpret clinical data and literature
  • Knowledge of AMA Manual of Style, other style guides, and any guidelines related to assigned projects.
  • Expertise in Microsoft Word, including advanced formatting, styles, cross-referencing, bookmarks, and other related skills.
  • Demonstrated ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects
  • Able to work in a fast-paced environment with shifting priorities and timelines
  • Excellent written and verbal communication skills, able to communicate effectively with different levels of management as well as with peers
  • Demonstrate initiative, sound judgment and flexibility
  • Highly motivated with the ability to be flexible in a fast-paced environment 
  • Excellent attention to detail

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

 

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.