OneTrust

Associate Director, Safety Analysis Scientist, Cell Therapy

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Raritan • New Jersey • Pennsylvania • United States

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Salary

💰 $137,000 - $235,750 per year

Job Level

Senior

About the role

  • Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
  • Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.
  • Provide input and review of key regulatory or clinical documents as appropriate.
  • Demonstrate leadership in the SMT and support the MSO.
  • Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
  • Lead proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.
  • Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
  • Assume responsibility for novel projects, create value and innovate without defined processes. May seek guidance from Directors (i.e., SAS Team Lead) for complex projects.
  • Lead cross-functional training of relevant stakeholders.
  • Act as product or process Subject Matter Expert (SME) for audits/inspections.
  • Participate in, or lead, department and/or cross-functional initiatives.
  • Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
  • Assist Directors in the creation, review and implementation of controlled documents and other related tools.
  • Management of unscheduled reports within the Aggregate Report Calendar.
  • Management activities within smaller Therapeutic Areas, as applicable.
  • Line-management of contractor positions within the team, as applicable.
  • Act as backup to Team Lead as needed (e.g., Director SAS Team Lead is unavailable).
  • Oversight of deliverables by other team members (e.g., complex reports), as needed.

Requirements

  • Bachelor’s Degree in a Healthcare-related or Biomedical Science is required with 8-10 years industry experience or equivalent.
  • An Advanced Degree is preferred in healthcare-related or Biomedical Science with 6+ years industry experience or equivalent.
  • Medical writing or Pharmacovigilance (PV) experience required.
  • Clinical experience preferred.
  • Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
  • Ability to understand and analyze complex medical-scientific data from a broad range of disciplines.
  • Ability to interpret and present complex data to determine benefit-risk impact.
  • Excellent English verbal and written communication skills.
  • Ability to effectively interact with stakeholders, including business partners.
  • Ability to work in a matrix environment, proven leadership skills.
  • Ability to plan work to meet deadlines and effectively handle multiple priorities.
  • Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
  • Ability to independently influence, negotiate and communicate with both internal and external customers.
Benefits
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical writingpharmacovigilancedata analysisreport writingsafety evaluationsregulatory document reviewsignal trackingdata presentationcomplex data interpretationhealth authority requirements
Soft Skills
leadershipcommunicationstakeholder interactionmatrix environment collaborationplanningmultitaskinginfluencenegotiationinnovationtraining