Laura J. Lenahan
Levittown,PA
Summary
Proven achiever in bioanalytical reporting and quality assurance, with a track record at Syneos Health for crafting engaging scientific content and enhancing compliance. Excelled in project monitoring and fostering teamwork, demonstrating exceptional attention to detail and collaboration skills. Expert in FDA regulations and Microsoft Office, driving project success and regulatory adherence.
Overview
8
8
years of professional experience
Work History
Reporting Associate II, Bioanalytical
Syneos Health
11.2017 - 05.2023
- Wrote and edited high-quality content and visually impactful scientific reports under deadline pressure with exciting, captivating, and authentic approach.
- Followed company policies and editorial guidelines to craft thorough, well-written content.
- Managed competing deadlines with efficiency.
- Prepared and submitted regulatory file applications and supporting documentation.
- Wrote or updated standard operating procedures, work instructions or policies.
- Proved successful working within tight deadlines and a fast-paced environment.
- Edited and proofread technical documents for accuracy and consistency.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Developed customized reports, summarizing and presenting data in visually appealing format.
Study Coordinator I, Bioanalytical Chemistry
COVANCE LABORATORIES, a LabCorp Company
11.2015 - 11.2017
- Utilized exceptional writing, editing, and proofreading skills to produce engaging and error-free content.
- Brainstormed ideas to create useful content for clients.
- Edited and proofread drafts of scientific reports.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Maintained compliance with internal SOPs and external regulations and brought compliance issues to attention of management.
- Developed customized reports, summarizing and presenting data in visually appealing format.
Quality Assurance Officer
Tandem Labs
06.2015 - 11.2015
- Conducted evaluations to identify weak areas and identify problematic issues while promoting corrective methods.
- Monitored activities and supporting systems to meet compliance regulations.
- Reported production malfunctions to managers and production supervisors.
- Performed root cause analysis to identify and resolve quality issues and defects.
- Conducted risk assessments to identify and mitigate potential quality issues.
Education
Bachelor of Arts - Biology
Arcadia University
Glenside, PA05-2007
Skills
- Microsoft Office
- FDA regulations
- Completing regulatory documents
- Project monitoring
- Drug development
- Good clinical practice
- Study protocols
- Accountability
- Attention to Detail
- Collaboration and Teamwork
Timeline
Reporting Associate II, Bioanalytical
Syneos Health
11.2017 - 05.2023
Study Coordinator I, Bioanalytical Chemistry
COVANCE LABORATORIES, a LabCorp Company
11.2015 - 11.2017
Quality Assurance Officer
Tandem Labs
06.2015 - 11.2015
Bachelor of Arts - Biology
Arcadia University
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