Regulatory Operations Sr. Publisher

Melinta Therapeutics LLC•Parsippany-Troy Hills, NJ

1d•Remote

About The Position

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.

Requirements

Knowledge, understanding, and experience with Veeva VAULT RIM authoring workflows, document metadata, naming conventions, Veeva submission publishing and Submission Archive
Knowledge and understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices
Thorough understanding of formatting MS Word documents and authoring templates/tools (StartingPoint templates, etc.)
Proficient in Microsoft Windows environment including, but not limited to: Microsoft Office Products, Adobe Acrobat and plug-ins; Microsoft 365 document management systems; publishing product lines. Experience with electronic IND and NDA publishing software
Thorough understanding of the eCTD structure as well as FDA and ICH specifications for eCTD submissions
Minimum of 5-7 years pharmaceutical industry experience. End-to-end submission publishing and document management experience (Veeva RIM Vault/Vault Publishing experience is a MUST) required with minimum of 5-7 years using publishing software. May have experience with, but not limited to: Veeva Vault (RIM, eTMF, Promomats – etc) Veeva Publishing, Lorenz docuBridge, Lorenz eValidator, Insight Manager /Publisher Insight Validator, ISI Toolbox, ESG gateway
Must be able to work independently and be dedicated to quality and meeting timelines.
Excellent verbal and written communication skills coupled with a great attitude/mindset/ability to work in and support collaborative team environment
Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple projects
Openness towards continual learning and improvement

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 functional duties as requested by management