Senior Medical Writer
Trenton Metro Area, NJ
- The Senior Medical Writer -
- PharmD, PhD, MS with 1 - 7 years of medical writing experience in support of clinical and regulatory documentation (eCTD format)
- Responsible for providing high quality medical writing, including efficient project leadership, for one or more clinical trials and also authoring and reviewing submission-level clinical/regulatory documents.
- Responsible for the expanded development, implementation, and maintenance of operations related to clinical trial registration and results disclosure.
- Assisting with responses to questions from regulatory authorities (eg, MAA and FDA)
- Contribute to regulatory submissions by authoring relevant sections of eCTDs (eg, ISS, Summary of Clinical Safety)
- Performing quality-checks of documents for agreement between in-text and source data
- Editorial review of documents, including submission-compliant formatting
- May be involved with the development, implementation, and maintenance of operations related to clinical trial results disclosure including authoring, collaborative review and revision, quality control activities, approval, and release/publication for public disclosure
- The candidate must be able to work independently and efficiently with cross functional team members.
- Will also engage in the project management of document support activities by others (QC and publishing) to deliver high-quality submission-ready documents in accordance with the agreed timelines.
- Advanced writing competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, and high attention to detail are essential.
- The applicant is desired to have previous experience in the writing and development of clinical trial results postings. T
- The applicant is desired to have experience in writing and reviewing standard operating procedures.
- A good understanding of medical terminology and AMA style is needed