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CMC Technical Writer

LanceSoft Inc

Ridgefield, CT

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analysis Skills, Analytical Development, Biotech and Pharmaceutical, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Detail Oriented, Document Management, Documentation, Drug Products, Editing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ICH Regulations, Investigational New Drug (IND), Leadership, Manufacturing, Marketing Authorization Application (MAA), Multitasking, Product Documentation, Quality Control, Regulations, Regulatory Submissions, Research Protocols, Statement of Work (SOW), Support Documentation, Team Player, Technical Delivery, Technical Support, Technical Writing, Time Management, Writing Skills
LOCATION
Ridgefield, CT
POSTED
13 days ago
Duties: We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD) at the client. This contract role combines deep expertise in DS/DP analytical development and quality control to support ongoing DS/DP external CMC development and demonstrated familiarity of Veera RIM system and technical writing capabilities to support documentation and global regulatory submissions (e.g., IND, CTA, NDA/MAA). The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations. Key Responsibilities Analytical Expertise Provide scientific leadership in phase appropriate external DS/DP analytical development/QC for NCE and NCE-like (e.g., Oligonucleotide) entities, including method development, validation, transfer and lifecycle management Contribute to development of DS/DP phase appropriate specifications and analytical control strategies in collaboration with internal and external teams Contribute to development of DS/DP stability programs and assignment of DS retest period, DP shelf life and material holding times as needed, with internal and external teams to support FIH and following clinical trials Independently propose or review quality agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a timeline fashion. Prepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teams Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events and ensure timely, compliant deliverables CMC Technical Writing Support departmental submission activities by managing documentation workflow workflow in Veeva RIM system Demonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug Substance and Drug Product) documents, in particular analytical related documents. Contribute to preparation of regulatory submissions/briefings and responses to health authority inquirie Skills: Required • Significant working experience (> 6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulations. • Demonstrated working experience in regulatory submissions • Familiarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP, EP, etc.) Preferred • Experience in global regulatory submissions (IND, CTA, NDA, MAA) • Experience working with external manufacturing or testing partners Key Skills • Strong organization and technical writing skills • High attention to detail and scientific rigor • Effective communication and stakeholder collaboration • Ability to manage multiple priorities in a fast-paced environment

About the Company

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LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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