Client is only considering candidates located in Connecticut or within commutable distance from Groton, CT office.
Candidate must be authorized to work on W2 for any employer in USA.
Non-local candidates are not eligible.
Job title: Non-clinical reporting and submission scientist
Location: Groton, CT 06340
Duration: 18 months contract
Schedule: Monday – Friday / First shift / Hybrid once training is completed / 3 days onsite
Interviews: First round Teams Meeting / Second round onsite
Request id# 33957-1
Job Description:
Primary Responsibilities
• Prepare PDM reports in an electronic submission ready format required for submission level documents such as pharmacokinetic reports and Toxicokinetics(TK) reports for both small and large molecule programs.
• Provides Toxicokinetics/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
• Bachelor's or master's 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.
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