Non-clinical Data and Reports Specialist - US Tech Solutions, Inc.

This is a hybrid or onsite role
Job Title: Non-clinical Data and Reports Specialist

Summary / purpose of the position
The nonclinical data and reports specialist will be part of the Research and External Innovation (R&EI) organization and will report into the VP early portfolio strategy and operations. The nonclinical data and reports specialist will support:· Client’s preclinical portfolio (across three therapeutic areas) by providing support for the data planning, preparation, and quality control of all nonclinical contributions to regulatory submissions, specifically INDs and CTAs· Assessment of external preclinical assets, with a focus on IND readiness and integration of preclinical data

Main Responsibilities / Job Expectations
Support Clients preclinical portfolio across Client’s Therapeutic Areas by leading, as part of trans functional teams, the planning, preparation, and quality control of all nonclinical data reports and written and tabulated sections of regulatory documents

• Support Early Development teams by planning and managing the preparation of nonclinical documents to support global regulatory submissions
• Support the preparation of summary sections (written and tabulated), research reports and briefing documents for INDs/CTAs/BLAs
• Conduct quality control of preclinical reports to ensure consistency across documents
• Organize and coordinate with Early Development Team Leaders, Early Development Project Managers and Alliance Managers on data requests and transfers from Partners
• Understand general data management systems and regulatory requirements for preclinical studies, and support integration of data from Partners
• Work closely with Head of Non-Clinical Drug Safety and Global Regulatory team to ensure cross functional alignment and high-quality deliverables
• Work cross-functionally to develop transformative strategy to deliver high quality preclinical data by identifying acceleration opportunities using balanced risk-taking
• Effectively collaborate and manage relationship with Nonclinical Regulatory Writing CRO for development of necessary submission documents and manage relationship between internal stakeholders and CRO.
• Work closely with Medical Writing Team to ensure proper support for nonclinical sections of regulatory documents (Investigator’s Brochure, Clinical protocol, etc.)· Support external innovation assessment of preclinical assets
• Work closely with Early Development leads to bring relevant expertise in support to any target assessment
• Participate in external opportunity evaluation of new assets through rigorous assessment of preclinical/translational data, recommending mitigation plan when additional data is required, thus ensuring the team delivers high quality due diligences
• Contribute to the assessment of IND readiness data package, perform gap analysis, propose mitigation plan with timeline and costs
• Build and leverage both internal and external network of stakeholders and experts to deliver assessment, mitigation plan and associated timelines and costs
• Work with scientific experts to triage, prioritize, and track recommendations
• Work closely with Head, Due Diligence and Integration to transition and integrate preclinical data from external partners

• Minimum of a bachelor’s degree in relevant scientific discipline, Master’s a plus.

• Minimum 5+ years biopharmaceutical industry experience 2+ years regulatory writing, preclinical strategy, and project management activities

• Previous successful experience in preclinical sections of IND/IMPD preparation in TAs and modalities addressed by Client (small molecules and biologics)
• Proven ability to manage projects
• Ability to interface with technical and scientific groups
• Interpersonal and facilitation skills necessary to drive alignment
• Strong analytical and problem-solving skills
• Ability to communicate with all levels of the organization
• Facilitation skills to develop solutions to address critical business needs
• High proficiency in Word, Excel, PowerPoint and collaborative working tools (ideally Teams/Sharepoint)