Regulatory Operations Sr. Publisher
Listed on 2026-02-07
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Healthcare
Why Cor Medix Therapeutics?
If you are interested in joining an entrepreneurial team, focused on bringing life‑saving therapies to market for critical unmet medical needs, consider applying for a role at Cor Medix Therapeutics. The culture at Cor Medix Therapeutics is patient‑centered where we feel a sense of urgency to solve some of the most pressing issues in hospital‑based healthcare. Cor Medix Therapeutics’s greatest asset is our people.
We have a deeply experienced team and continue to bring on some of the brightest talent that can problem‑solve and execute with high‑precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose.
We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.
Cor Medix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life‑threatening conditions and diseases. Cor Medix is commercializing Defen Cath® (taurolidine and heparin) for the prevention of catheter‑related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, Cor Medix is also commercializing a portfolio of anti‑infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL‑XL® (metoprolol succinate).
Cor Medix has ongoing clinical studies for Defen Cath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop Defen Cath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT.
Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: or
The Regulatory Operations Sr. Publisher collaborates closely with counterparts in Regulatory Affairs/Cross‑functional SMEs and is responsible for managing submission timelines, ensuring submission readiness, and strengthening operational excellence across the organization, including maintenance of eDMS (Electronic Document Management Systems) documents.
Primary Responsibilities- Responsible for the creation, assembly, and publishing of both major and routine electronic submissions, including NDAs, INDs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, AdPromo, etc.
- Ensure that metadata is correctly applied so that documentation is retrievable and searchable within the company (eDMS) and engage in life cycle management of submission documents to ensure document integrity in eDMS and publishing tool.
- Format Microsoft Word documents using content templates or Microsoft Word styles consistently to prepare for electronic submission publishing.
- Publish and verify documents meet all applicable regulatory submission standards according to internal policies and current Health Authority/ICH (International Conference on Harmonisation) standards/specifications, such as creating bookmarks, internal/external hyperlinks, etc.
- Perform quality control reviews and follow procedures to identify, document, and remediate findings.
- Manage document management tasks including file transfer, storage, tracking, and archival services.
- Populate and maintain Reg Ops Submission Calendar.
- Archive correspondence and submissions to/from Health Authorities into eDMS.
- Utilize Electronic Submission Gateway (ESG) to submit submissions to FDA/other Health Authority.
- Update trackers, correspondence logs, metrics on daily/weekly/monthly basis as internal policies dictate.
- Other…
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