CMC Strategist and Author Job at Apex Systems in Overland Park

Apex Systems is seeking to add a Remote CMC Strategist and Author to our healthcare client located in Overland Park, KS. The candidate will be responsible for producing submission documentation, utilizing specified templates, formats, and databases within agreed timelines for various CMC components.

Compensation: $40-44/hr ($60-66/hr for overtime hours when/if applicable)

Schedule: M-F regular business hours

Format: Fully remote

Responsibilities include, but are not limited to, the following submission types:

• Clinical trial applications and amendments
• Quality sections (Module 1, Module 2, Module 3) of registration dossiers (US, EU, other regions), including preparing international marketing applications (e.g., International Registration Dossiers, NDS, BLA, and JNDAs) from initial CTDs and Drug Master Files
• Annual Reports (IND, NDA, ANDA, NADA, DMF, Canada YBPR)
• Post-Approval Supplements and Variations, Renewals, and Assessments for compliance

CMC activities may include:

• Using CMC templates and source documentation from technical teams to prepare or author CMC sections (Module 1, Module 2, and Module 3) for clinical trial applications and amendments, registration dossiers, annual reports, and post-approval variations and renewals.
• Preparing and updating CMC sections of Marketing Applications and Authorizations.
• Developing CMC regulatory post-approval filing strategies and variations for global products.
• Developing CMC regulatory strategies for product development for global products.
• Preparing CMC sections for US Annual Reports; ensuring that regulatory documents are prepared accurately, completely, and on time.
• Managing post-approval CMC changes for products manufactured at client facilities and contract manufacturers.
• Preparing responses to Health Authority queries and requests for CMC information.
• Preparing DMF and CEP dossiers in submission-ready format according to FDA and EDQM guidelines.
• Performing regulatory authority inspection readiness audits of client systems and facilities.
• Performing vendor qualification audits on behalf of clients.
• Maintaining fluency in emerging global CMC regulations.
• Liaising with clients on technical details of the submission or project as required, including submission-specific strategy development in collaboration with clients.
• Liaising with clients for overall project management/relationship management.
• Verifying data of CMC submission sections against verified source documentation provided by the client.
• Converting older submissions to contemporary standards, including:
• Using a roadmap to define where content from an older submission should be placed in the CTD structure, moving, copying, or re-keying text, and formatting accordingly.
• Filling gaps in the submission with data from reports or other sources and authoring text to put the data in context.
• Reviewing/assessing the dossier against contemporary regulatory compliance standards, recommending alternative approaches to address data gaps, and preparing scientific justifications as needed.
• Verifying document manipulation steps against the source document for proofreading, transcription, and OCR accuracy prior to dossier analysis and completion.

Required Skills:

• Regulatory CMC
• Organic Chemistry
• Analytical Chemistry
• Problem-Solving

Additional Skills:

• Technical Documentation
• Regulatory Affairs
• Database Management

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.