Non-Clinical Reporting and Submission Scientist

Job Title: Non-clinical reporting and submission scientist
Location: Groton, CT - Hybrid
Hours/Schedule: Monday - Friday / First shift / Hybrid once training is completed / 3 days onsite

Primary Responsibilities

• Prepare PDM reports in an electronic submission ready format required for submission level documents such as pharmacokinetic reports and TK reports for both small and large molecule programs.

• Provides TK data interpretation for exploratory tox studies.

• Prepares SEND datasets.

• Prepare NCP / PDM sections of submission documents (such as Briefing Documents, IND, IB, CTA, NDA, BLA etc.) working in partnership with the submission lead and the biology lead or PDM project representative.

• Provide guidance and promote quality and good documentation practices in PDM based on knowledge of regulatory requirements, departmental guidelines, authoring and QC experience.

• Collaboration with PDM scientists to ensure that appropriate information is included in regulatory submissions and that supporting documentation (study reports and data) is in place.

Experience/Education

• Bachelors or Masters Degree or equivalent experience in chemistry, biochemistry, biology or related discipline with experience in drug development and regulatory compliance within the pharmaceutical industry.

• Knowledge of the relevance and impact of ADME studies in drug discovery and development.

• Working knowledge of pharmacokinetics and drug metabolism science (both large and small molecule).

• Experience within the pharmaceutical or biotechnology industry involved in drug discovery and development.

• Solid knowledge of report writing tools and ADME systems - Predict, Word , Excel, Adobe, Document management systems, Galileo, Watson Openlab, SimCyp and WinNonLin.

• Ability to communicate and influence/negotiate effectively (orally and in writing) with colleagues at all levels of the PDM organization.

• Experience authoring study reports (large and small molecule) and contributions toward document preparation for regulatory submissions with a proven aptitude for scientific writing and QC (e.g. reports, memos, written summaries) under established timelines to meet project milestones.

• Ability to analyze, devise and implement improvements/solutions to business issues.

• Strong project management skills.

• Ability to lead initiatives and work in a highly matrixed environment.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.