What are the responsibilities and job description for the Analytical Development CMC Writer position at VARITE INC?
VARITE is looking for qualified Analytical SME & CMC Technical Writer
WHAT THE CLIENT DOES?
A global, research-driven pharmaceutical company that focuses on developing innovative medicines in areas such as human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing.
WHAT WE DO?
Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850 global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.
Job Title: Analytical SME & CMC Technical Writer
Location: Remote (EST hours)
Contract Duration: 12 months
Pay Rate Range: $55.33/hr - $59.28/hr on W2
Work Authorization: USC or GC
HERE’S WHAT YOU’LL DO
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 ***.
- 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.
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
- 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 inquiries
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.)
- 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
Education:
- Advanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline
BENEFITS:
We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:
- Health Insurance: Medical, dental, and vision coverage
- Retirement Plans: Participation in a company-sponsored retirement savings plan.
- Legal Service Plans: Offering access to attorneys for legal advice and representation.
If this opportunity interests you, please respond by clicking on EasyApply.
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VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Salary : $55 - $59