Job Description

The Opportunity:

We are seeking a talented Publishing Specialist to join our dynamic team. In this role, you will play a crucial part in ensuring the successful submission of client applications to health agencies worldwide. If you thrive in a detail-oriented environment and have experience with regulatory submissions, we want to hear from you!

What You’ll Do:

· Submission Preparation: Utilize publishing software to assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) that comply with eCTD requirements.

· Client-Centric Focus: Prioritize client needs by delivering high-quality submissions that align with their goals and expectations.

· Excellence in Service: Strive for excellence in every submission, ensuring that client deliverables meet the highest standards.

· Quality Control: Perform thorough QC checks on submissions, ensuring adherence to regulatory guidelines and internal processes.

· Global Team Collaboration: Working cross-functionally, participate in submission planning meetings, track document progress, and stay updated on current regional regulations.

· Project Leadership: Act as Lead Consultant for publishing projects, managing timelines, client communications, and submission quality.

· Agency Communication: Engage with regulatory agencies to address technical queries and resolve any submission issues.

· Billability Targets: Consistently achieve billability targets set by leadership, demonstrating a strong commitment to the team's goals.

Requirements

What We’re Looking For:

• Experience: A passionate regulatory science professional with 1+ years of relevant experience, with a solid understanding of eCTD submission processes.
• Educational Background: AS/BA/BS degree in Regulatory Affairs or Life Sciences preferred.
• Values: Embody our core values – People, Innovation, Passion and Excellence.
• Detail-Oriented: Possess a meticulous eye for accuracy and strong organizational skills .
• Team Player: Thrive in a collaborative environment and demonstrate excellent communication skills.
• Project Management: Problem-solving abilities and able to meet project deadlines.
• Technical Proficiencies: Microsoft 365, Adobe, and electronic submission software (e.g. docuBridge) preferred.

Benefits

Why VCLS:

• Make a Difference: Contribute to the development of life-saving therapies and accelerate progress in the field.
• Learn and Grow: Work alongside industry experts and gain invaluable mentorship.
• Dynamic Environment: Be part of a passionate team dedicated to client success and innovation.
• Growth Potential: Build a rewarding career in a company that fosters continuous learning and development.

VCLS is committed to fostering a diverse and inclusive workplace. We are a proud equal opportunity employer and value the unique contributions of all individuals. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

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