Senior Manager, Clinical Publishing

Clinical Waltham, Massachusetts


Description

Position Summary:

The Sr. Manager of Clinical Publishing is a key member of the Medical Writing team. This person will establish and maintain a standard process for the quality verification, submission-readiness, and publishing of clinical, regulatory, and/or safety documents. This person will serve as the interface between Medical Writing and Apellis Regulatory Operations to collaboratively establish standards of and expectations for document publishing at Apellis. In addition to publishing responsibilities, this person will work with Apellis’s inspection-readiness team to ensure the Medical Writing department meets inspection-readiness requirements as Apellis works towards global submissions.

Key Responsibilities Include:

  • Will perform and/or direct publishing and quality review of clinical, regulatory, and/or safety documents.
  • Will serve as the lead contact between the Medical Writing department and Regulatory Operations.
  • Will own all publishing-related responsibilities and direct publishing-related processes for the Medical Writing department.
  • Responsible for building and managing the clinical publishing process and maintaining standards and document templates. This includes periodic assessment of process to identify areas of potential improvement.
  • Will assist in the planning of global submission-related activities.
  • Responsible for submission-readiness of all document-related deliverables.
  • Will determine potential need for external publishing support and will provide oversight of any vendor utilized.
  • Will assist editors with QC, formatting, style guide adherence, and basic proofreading.
  • Will assist in verifying that document content is consistent with internal, client, and related authority guidelines.
  • Assist writers or other team members with supportive tasks (eg, tracking documents) as requested.
  • Assist with literature searches, reference management, bibliographies, and libraries.
  • Will work with Apellis’s inspection-readiness team to ensure the Medical Writing department is compliant and will direct inspection-readiness efforts for the Medical Writing Department.

Education, Registration & Certification:

  • Bachelor’s Degree or equivalent industry experience

Experience:

  • At least 4 years prior experience in the pharma/biotech industry is required, with at least 2 years in clinical publishing

Skills, Knowledge & Abilities:

  • Experience in quality review and publishing 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.
  • Expertise in Adobe, 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.