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.

Ref: #568-Clinical

Full Time