Manager of Medical Writing -Remote
Company: Aequor Technologies LLC
Posted on: January 26, 2023
TITLE: Manager of Medical Writing
100% REMOTE WORK
Oncology experience is preferred,
Regulatory Writing is preferred, other rare disease therapeutic
areas are considered .
The Manager of Medical Writing accountable for the timely delivery
of high quality, regulatory-compliant documents including but not
limited to protocols, IBs, clinical study reports, health authority
briefing books and clinical summary documents for assigned program
and ensures documents are delivered per corporate objectives, from
planning through internal approval.
Responsibilities and Duties:
- Responsible for the development of high quality clinical
documents submitted to Regulatory Authorities (e.g. FDA and EMA)
including Clinical Study Reports, Investigator Brochures,
Protocols, Protocol Amendments, Briefing Documents, Health
Authority responses, and clinical summary sections of Common
Technical Documents (CTDs) in support of worldwide (outside of
Asia) regulatory submissions.
- Collaborates with Global Development Teams and Clinical
Development to ensure alignment with program objectives.
- Oversees and reviews medical writing deliverables assigned to
contractors or other third party vendors.
- Participates in Global Medical Writing initiatives on clinical
development cross-functional teams.
- Assists with development and implementation of Medical Writing
processes improvement in line with SOPs.
- Owns and updates assigned Medical Writing SOPs, as
- Bachelor's Degree in life science, health-related or
pharmaceutical field, or the equivalent in experience. Advanced
- Minimum of 5 years combined experience in academic/clinical
and/or industry setting writing clinical protocols, CSRs and/or
medical and/or scientific documents.
- Previous experience in Medical Writing in clinical drug
development, preferably some experience in Oncology.
- Familiarity with the regulatory submission process, ICH and GCP
guidelines and recommendations.
- Knowledge of template development, document management systems
- Strong working knowledge of Medical Writing requirements and
- Good interpersonal skills that involves working well in a team
environment and the ability to lead others.
- Strong PC skills including Medical Writing software, Windows
and MS Office products specifically Word, Excel, MS Project, and
PowerPoint (and any additional software packages utilized ).
Keywords: Aequor Technologies LLC, Trenton , Manager of Medical Writing -Remote, Advertising , Princeton, New Jersey
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