Propharmagroup
Senior Non-Clinical Editor (Consultant)
United States · Senior
Sponsorship not specifiedDetected 2 days ago
Product ManagementExcelProcess ImprovementClinical TrialsClinical ResearchPharmacovigilanceResearchCommunicationTime ManagementMicrosoft OfficeSharePoint
About the role
- Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
- With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
- All applications to roles at ProPharma are personally reviewed by a member of our recruitment team.
Responsibilities
- ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
- This position is responsible for overall quality control (QC) review and submission-ready publishing of nonclinical documents.
- This role will support all documents written by authors from Drug Metabolism and Biopharmaceutics (DMB), Chemistry Manufacturing and Controls (CMC), Toxicology (Tox), and Translational Sciences.
- This position may also assist in clinical document QC and publishing tasks when appropriate to meet submission timelines.
- The Senior Nonclinical Editor performs the activities with minimal oversight needed.
- Perform internal document QC review of nonclinical documents (eg, DMB, CMC, TOX, TRS, PRECLIN) to ensure compliance with the Incyte Style Guide, template formatting, and submission ready standards.
- Perform publishing of PDF documents to Incyte submission-ready standards.
- May involve multiple document compilation of PDF files to include appendices.
- May interact cross-functionally to support clinical and nonclinical processes and template updates.
- Ability to effectively communicate with vendors and manage outsourced editorial work.
Requirements
- Strong working knowledge of the editorial and publishing activities within Clinical Development.
- Proficient in Microsoft Word, including the ability to format tables, insert cross-references, apply styles, and use templates.
- Experience with PowerPoint, Excel, Visio, Adobe.
- Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.
- Experience in the use of an EDMS (eg, Veeva Vault or SharePoint).
- The Senior Nonclinical Editor will copyedit/proofread, format, and perform internal consistency review of document content in accordance with company SOPs and processes to ensure documents meet required standards.
- Proofread documents against the standard templates to ensure compliance with required sections and text.
- Minimum Requirements
Benefits
- Assist Medical Writing Operations staff with clinical document QC and publishing, as appropriate.
- Participate in process improvement initiatives and support Medical Writing staff with other tasks, as appropriate.
Apply directly at Propharmagroup →Create a free account for alerts like thisView Propharmagroup immigration profile
This listing is sourced directly from Propharmagroup's careers page and normalized into a canonical job model.