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Documentation Analyst
Ref No.: 18-09608
Location: Pennington, New Jersey
Job Description: Job Description

CMC DOCUMENT SPECIALIST

Description

The primary role is to support the documentation activities for regulatory submissions for biologic products as part of the CMC Strategies team. The CMC group is committed to supporting the biologics network with integrity, reliability, active engagement and cross-functional collaboration.

Duties and Responsibilities:

• Support the logistical process for regulatory submissions including pre and post submissions while interfacing across the company network.
• Assist with dossier creation and system compliance for regulatory submissions.
• Assist in the facilitation of authoring, review, verification and submission-ready compliance for the finalization of filings.
• Participate in initiatives involved with regulatory filings.
• Participation on various cross-functional project teams, interactions with MS&T, TPT, IDT, SLT and GRS-CMC staff at different company sites and other key partners both internal and external to the company are necessary.
• Must possess the ability to support multiple projects and to prioritize work independently.
• Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
• Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.

Requirements and Education:

• BS/BA degree required. 0-2 years of direct pharmaceutical work experience preferred. Advanced degree is an asset.
• Excellent organizational, communication and project management skills are required along with proficient navigation of electronic systems.
• Must demonstrate an understanding of the global CMC regulatory guidelines, practices and applications.
• Must have a working knowledge of regulatory submissions for pre and post filings.
• Ability to successfully collaborate with a diverse group of technical professionals and interpersonal styles is required.
• Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines and ensuring the most efficient regulatory process.
• Possess strong interpersonal skills and demonstrates ability to effectively interact with business functions.
Additional Job Requirements:
None