Technical Director managing technology delivery, operations, and innovation across APAC at IDEMIA. Ensuring client infrastructure and systems are implemented and managed to the highest standards.
About the role
- Part of the Global Non-Clinical Safety (NCS) team reporting to the Head of the Non-Clinical Safety team
- Serve as a key member of international, multidisciplinary project teams and work closely with NCS Leads
- Lead author of nonclinical toxicology documents and coordinate scientific content
- Represent NCS on global regulatory submissions project teams for Annual Reports, Briefing Books, Common Technical Documents, Safety Update Reports, Investigator’s Brochures, INDs, MAA, and NDA/sNDAs
- Author, coordinate, monitor, review and/or approve nonclinical responses to Health Authorities for pending applications
- Manage and coordinate completion of documents within established timelines and quality standards
- Escalate issues when necessary to maintain project timelines and performance standards
- Position can be based in Princeton, NJ or Copenhagen, DK
Requirements
- MS in toxicology, pharmacology, or related field required
- PhD preferred
- At least 10 years of recent and relevant experience as a nonclinical writer of toxicology studies for biologics and/or pharmaceuticals
- Extensive experience with Acumen, DocuBridge, or similar regulatory document submissions tools
- Strong project management, organizational, and communication skills (both written and verbal)
- Solid understanding of regulatory guidelines and document management standards
- Speak and write in English fluently
- Ability to work independently and produce high-quality documents with minimal supervision
Benefits
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
- Discretionary bonuses and long-term incentives
- Agile working environment with hybrid work arrangements
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