Candidate will prepare SEND datasets and nonclinical documents for regulatory submission.
Technical preparation of datasets:
- Prepare timely, FDA compliant SEND datasets, define files and Study Data Reviewer's Guides
- Understand and comply with Regulatory guidance documents used in dataset preparation
- Understand and comply with FDA business rules used in dataset preparation
- Capably use software and other tools to create compliant datasets and domains
Troubleshooting and quality control of dataset packages:
- Integrate knowledge of AbbVie study conduct to assure correct dataset output
- Knowledgably interact with study personnel as needed to prepare, review and troubleshoot dataset packages
- Use knowledge of Regulatory requirements and Toxicology study conduct to resolve and/or provide rationale for validation errors and warnings
- Communicate findings to team members and management
- Prepare Study Data Reviewer's Guide
- Manage marketing application sections during preparation period; filing team SME participant
- Define and communicate deliverables, quality targets and timelines
- Develop Toxicology study knowledge/ expertise
- Stay current with changing Regulatory requirements and industry norms
- Process protocols, reports, submission documents and other documents, as assigned and on a timely basis
- In-depth knowledge of MS Word
- Ensure high quality compilation and QC of Pathology, Toxicology, Genetic Toxicology, and other reports within specified timelines.
- Create Virtual Document of report and M4 of Regulatory Submissions to assist in quick compilation completion.
- Prepare early drafts of Toxicology Reports, Toxicology sections of INDs and NDAs, Toxicology Tabulations, Abstracts, IND Annual Reports.
- Ensure issuance and correct distribution of all protocols and amendments
- Knowledge of where reports and submission documents fit into regulatory submissions
- Coordinates and assists with preparation of JNDA inventories and GLP Compliance Statements
- Key responsibility is drafting and quality control checks of all assigned document content within defined standards (non-scientific)
- Accountable for Quality Control checks of regulatory documents, etc. for consistency and errors per process
- Creates and QCs Toxicology sections of submission planners for Regulatory submissions
- Accountable for Quality Control checks of Regulatory submissions in eCTD Express
- Actively maintain timelines for reports and submissions by tracking timelines for submission documents, and reports and their components. Works proactively with authors and project reps to meet deadlines.
- Produce finished documents in a timely and organized manner
- Provide support and help ensure user testing is conducted for system upgrades
- Maintains document and submission tracking for all documents
- Routinely engages management for issue and timeline status, quality and/or content questions
- People leadership, collaboration and teamwork skills necessary for small team and external business interactions/communications
- Understanding of Toxicology or related nonclinical study conduct and design as it relates to data in submission package. GLP (or related regulatory environment) experience preferred.
- Ability to work independently while contributing as an effective, collaborative team member
- Resolution oriented- uses reasoning to troubleshoot and provide possible solutions to issues regardless of origin, relentlessly seeks root cause of issues
- Gathers appropriate background quickly, seeks input of subject matter experts and management, proposes solutions
- Experienced and facile with computer systems and software.
- Works with a proactive mindset, prepares and communicates an action plan and potential issues - must be able to provide services and results on time, accurately and consistent with expectations
- Must demonstrate and consistently use excellent communication skills, both verbal and written. Ability to communicate complex, technical issues clearly
- Ability to prioritize multiple tasks/projects and strong organizational skills against management provided information
- Seeks management input when needing information, doesn't jump to "that's the way we always do it"
- Detail oriented while understanding and acting against the "big picture"
- Must demonstrate and consistently use excellent interpersonal skills
- Ability to integrate and retain new information quickly (quick learner)
- Abile to act as a change agent: system upgrades and migrations, business process improvements, priority management
- Bachelor of Science Degree in Biology or related field required
- At least five years' experience supporting nonclinical research and development in the pharmaceutical industry preferred
Equal Opportunity Employer Minorities/Women/Veterans/Disabled