(Associate) Director of Medical Writing

argenx - Boston, MA

Full-timeEstimated: $130,000 - $170,000 a year

argenx is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.

For the expansion of our team, argenx is looking for an (Associate) Director of Medical Writing, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports and other key clinical and regulatory documents. This individual will support the overall strategy for all medical writing processes according argenx standards.

Key Accountabilities/Responsibilities:

  • Support the clinical medical writing team, in developing content for, writing and editing a variety of scientific and medical documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives and annual reports
  • Draft and manage documents that are well-organized, accurate, consistent, and in compliance with applicable company SOPs and regulations
  • Ensures all clinical documents are standardized with the use of document templates, in order to ensure the quality and consistency of documentation across programs
  • Partner with Quality Assurance (QA) during audit of clinical documents to ensure timely response to findings
  • Collaborate with clinical project teams including Project Manager, Clinical Study Managers, Medical Directors and Biostatistics to ensure project deadlines are met, by providing content development support, research, and editing functions for each program
  • Ensure proper development and coaching of junior writers

Desired Skills and Experience:

  • Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferred. Minimum of 5-7 years of pharmaceutical/biotechnology related medical writing experience required
  • Knowledge of all FDA and ICH guidelines for clinical reporting required
  • eCTD development, publishing and submission experience preferred
  • Therapeutic experience in biologics preferred
  • Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
  • Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
  • Ability to proofread documents for compliance with internal and external guidance documents

Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion

  • Ability to work precisely according to procedures and regulations
  • Excellent written and verbal communication skills
  • Ability to prioritize and multitask successfully in a fast-paced environment
  • Ability to work autonomously, as well as in a team
  • Excellent time management skills and a proven ability to work on multiple projects at any given time.
  • Must be proficient in MS Office
  • Experience in electronic publishing format preferred

Job Type: Full-time


  • relevant: 5 years (Preferred)

Work Location:

  • One location


  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off
  • Professional development assistance

This Company Describes Its Culture as:

  • Detail-oriented -- quality and precision-focused
  • Outcome-oriented -- results-focused with strong performance culture
  • Stable -- traditional, stable, strong processes
  • People-oriented -- supportive and fairness-focused
  • Team-oriented -- cooperative and collaborative

This Job Is:

  • A job for which all ages, including older job seekers, are encouraged to apply


  • Monday to Friday