Madison, NJ - Senior CMC Technical Writer

Job Description:

• The primary responsibility is to prepare Modules 2 and 3 in the Common Technical Document format (CTD) for the Chemistry, Manufacturing, and Controls sections of Marketing Authorizations for new product submissions and preparation of variations
• The incumbent will work with the technical groups at manufacturing/packaging and release sites to ensure that GMP-related documentation is complete and appropriate for the authoring of various sections of the submissions
• The Technical Writer will liaise with the CMC Strategist to effect review and approval of all submission components with the applicable review teams
• In addition, the Technical Writer will provide required assistance to the Regional CMC Conformance Hubs to ensure assembly and transmission of the final submission to the company’s Country Offices to meet project deadlines
• Assist the CMC Strategist in the evaluation of Regulatory Change Controls when necessary
• Under the direction of the CMC Strategist, collect required technical documents to author submissions according to the defined Table of Contents
• Author all submissions in the CTD format in English using approved PREDICT templates
• Ensure the timely preparation of submission components in alignment with pre-determined timelines
• Ensure the timely review and approval of submission components with the pre-determined review teams, including, but not limited to, plant technical groups, QA, Regional CMC Conformance Hubs, Regional and PCO Regulatory Managers
• Ensure compliance with all applicable SOPs governing the Regulatory Change Management processes
• Strictly adhere to all project timelines and immediately raise issues that may delay these timelines to the supervisor

Key Decisions:

• Participates in decisions and provides input regarding the adequacy, accuracy, interpretation, and clarity of technical information/reports prepared by plant functional groups to support submission-related activities
• Consults with appropriate groups (as required) regarding the acceptability of submission documentation
• Obtains the appropriate regional / central regulatory management input as required

Key Interfaces:

• PCO and  Regional Regulatory
• Site Quality Operations Groups
• Site Technology Groups (Tech Services, Tech Ops)
• External Partners

REQUIREMENTS:

• Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry
• OR MS/PhD/Pharm.D. plus 3-4 years of relevant industrial experience in the healthcare industry
• Minimum of 1-2 years of hands-on CMC authoring experience for initial registrations and post marketing variations is mandatory
• Comprehensive understanding of CTD format and content is mandatory
• Experience working in the Pharmaceutical manufacturing industry (preferably in QA, Technical Services, Operations, manufacturing plant or Research & Development), knowledge of pharmaceutical development process, cGMPs and regulatory requirements is required
• Excellent English writing and oral presentation skills mandatory
• Prior experience with Consumer Healthcare Products highly desired
• Prior experience managing projects is preferred
• Regulatory experience with both US and international countries submission types is highly preferred

Key Competencies:

• Project Management
• Organization and Time Management
• Communication (Verbal, Written, and Interpersonal)
• Influence/Negotiation
• Collaboration
• Relationship Building

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