GENERAL SUMMARY OF DUTIES – This position will have the overall responsibility for: editing, proofreading, formatting, and managing various clinical regulatory documents (such as protocols, amendments, clinical study reports, patient informed consents, IND submissions, etc.). The Medical Editor will assure efficient document flow and quality review of documents. The Medical Editor will assist in the development of and maintenance of SCRI internal Medical Writing style guidelines, policies, and .procedures. The Medical Editor will work in conjunction with SCRI Medical Writers and other departments within SCRI, as appropriate, for the effective and timely delivery of high quality documents.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
- Editorial review of various types of clinical/regulatory documents for grammatical and formatting correctness, as well as consistency per SCRI internal styles, policies, and procedures.
- Provide support to Medical Writers with administrative tasks, document management (routing, communications), etc.
- Write Summary of Changes documents
- Write Protocol Amendments and other documents as appropriate.
- Manage SCRI styles and approved formats, templates, content for IND submissions, and guidelines for clinical documentation in order to maintain consistency and high quality.
- Ensure proper adherence to SCRI templates, global standards, and FDA, ICH, and GCP guidelines.
- Manage document repository.
- Completion of projects in accordance with internally established timelines.
- Manage communication of status with customers and management.
- Train incoming editors, as needed.
- Adhere to SCRI Services SOPs and applicable Guidance Documents.
- Participate in educational activities and programs.
- Maintain the strictest confidentiality.
- Perform related work as required.
KNOWLEDGE, SKILLS, & ABILITIES – This position requires the following minimal requirements:
- Thorough understanding and ability to consistently apply use of SCRI templates, formatting guidelines, and procedures.
- Understanding of GCP, ICH guidelines, and local regulations.
- Ability to meet deadlines.
- Excellent editing, problem-solving, and organizational skills.
- Strong verbal, grammatical, written, and interpersonal communication skills are essential.
- High attention to detail.
- High level of proficiency with MS Office products, particularly Word.
- Bachelor’s degree or equivalent combination of education and experience.
- Two to three years minimum of relevant editing or writing experience in any field, or 4-year degree in a discipline that provides significant writing skills/experience.
- Experience with preparation of professional documents and/or research publications desired; experience with regulatory documents and processes beneficial.
- Or equivalent experience
HCA Inc - 21 months ago