VCLS: Accelerating the Path to Patients
Since 1997, VCLS has supported biotech, Medtech, and Healthtech innovators on their journey from discovery to patients. Our mission is simple and bold: accelerate life-changing products to market. With 230+ experts worldwide, we are committed to a long-term vision: help deliver 500 new healthtech products by 2050.
We are excited to be recruiting a Senior Publishing Specialist to our team in Bangalore.
As Senior Consultant – to format, Publish and deliver in a timely manner of high quality scientific documents to align with product development and registration strategy addressing multiple client projects
As Lead Consultant – where applicable : ensure smooth and close communication with the client. Monitor, Prioritize and supervise project activities. Communicate as appropriate to project team members and to the Account Manager
Manage and mentor colleagues, depending on organizational needs.
MAIN RESPONSIBILITIES
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Management of Publishing projects, maintaining submission trackers, ensuring quality and timeliness of Client deliverables and submissions
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Prepare, assemble, and submit applications to US, EU, UK, Switzerland, Canada and Australia (IND/CTA/NDA/MAA/BLA), etc
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Lifecycle management of submissions from planning, monitoring, publishing till dispatch and communication to the relevant stakeholders.
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Creating eCTD compliant PDFs, publishing sequences in docuBridge, creating internal and external document hyperlinks
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Work in close collaboration with Global Regulatory teams when Publishing is included in a larger project
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Perform technical QC of submissions before dispatch to Regulatory Authorities, ensure submissions are published in accordance with the relevant ICH and local guidelines and internal procedures
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Dispatch submissions to Regulatory Authorities via agency portals
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Communicate with regulatory agencies with respect to electronic regulatory submissions, answering technical queries, resolving technical issues (with relevant IT support)
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Stay abreast of ICH and regional requirements and ensure publishing software is in line with regional eCTD validation criteria
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Create tools for easier management of submissions/tasks
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Participate in the update of internal eCTD Distinct Technical Procedures (DTPs)
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Provide training and mentoring to eCTD Specialists (when applicable)
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Other duties as assigned
Requirements
QUALIFICATIONS, KNOWLEDGE, SKILLS, & EXPERIENCE
Life Science Graduate + solid academic background in Life Sciences;
- 5+ years proven professional experience in associated fields;
- Experience in analyzing, writing and summarizing;
- Able to train/coach less experienced consultants.
- Direct interactions with regulatory agencies is a plus;
- Experience in a consulting environment is a plus;
- Good command of MS Office (Word, Excel, PowerPoint);
- Experience in Project Management.
- Strong problem solving skills;
- Demonstrated ability to manage and build relationships with colleagues and regulatory authorities.
