Jacquelyn E. Briggs Email & Phone Number

Cambridge, MA, US

Boston, MA, US

Professor for Online, In-Class, and Hybrid Classes for a variety of courses in Regulatory Affairs and Biotechnology departments including: - Pharmaceutical and Medical Device Law: Topics and Cases (RGA 6203)- Legal Issues in International Food, Drug and Medical Device Regulation (RGA 6204)- Laboratory Management (RGA 6230)- Clinical Trial Agreements and.

Regulatory Advisor for the Cannabis Industry

Ingelheim Am Rhein, Rhineland-Palatinate, DE

Ingelheim Am Rhein, Rhineland-Palatinate, DE

Ingelheim Am Rhein, Rhineland-Palatinate, DE

Basking Ridge, NJ, US

• Draft, negotiate and manage a broad range of agreements including but not limited to: clinical trial agreements, master services agreements, work orders, license agreements, vendor agreements, consulting agreements.
• Responsible for the company’s timely filings with the SEC, including the annual 10-K, the quarterly 10-Qs, 8-Ks, Proxy Statements/DEF14A, Registration Statements, and Section 16 filings in collaboration with internal.
• Provide corporate governance support to the GC by preparing board and board committee materials including unanimous written consents, resolutions and D&O questionnaires.
• Organize and conduct the quarterly Disclosure Committee and liaise with the finance department.
• Legal due diligence, drafted and reviewed transaction terms sheets and documents for collaboration or merger and acquisition activity.
• Coordinate all preparations for Annual Meetings.

San Diego, CA - California, US

Regulatory Affairs consultant and provided Clinical Operations monitoring services.

Primarily focused on medical malpractice

• Home-based contracted Clinical Research Associate/Consultant. Responsible for FDA clinical trial compliance, writing collaboration and clinical monitoring for the following imaging and radiotherapy clinical trials.
• Responsible for writing and reviewing the following clinical documents for various clinical trials:o Clinical protocols and protocol amendment(s) accompanied by the supporting change document(s)o Standard Operating.
• Responsible for conducting weekly and bi-weekly vendor teleconferences for study project updates.
• Clinical representative at Team Meetings to provide clinical updates at the site level and on a more broad level by providing timelines using MS Project and assisting with site selection.
• Responsible for reviewing and providing sites with all necessary documents for IRB submission/approvals along with all study specific manuals (such as a Pharmacy Manual, Infusion Manual, Imaging Manual etc.).
• Responsible for developing and negotiating site budgets for clinical trials; along with ensuring the CDA, CTA, FDF, 1572 and all other regulatory documents are completed and fully executed appropriately prior to and.

Morrisville, NC, US

• In-house/home-based clinical research monitor, responsible for the regulatory documents and Trial Master File (TMF) maintenance of various domestic and international drug, and biologic research trials ranging in phases.
• Cardiovascular Disease
• Oncology
• Nephrology
• Gastroenterology
• Spinal Surgery

Primary contact person for clinical research studies, responsible for conducting initial patient screening, scheduling patient appointments, assisting patients with the consent process, and sending letters and questionnaires to patients. Inform CRC's (Clinical Research Coordinator) of eligible participants and provide them with all necessary documentation.

Providence, Rhode Island, US

Completed an extensive six-month management development program, with a focus on federal banking regulations, product knowledge, and effective management techniques. Surveyed and wrote reports to upper management the level of customer service at various branches Trained new and existing employees on updated computer software, and measured the performance.

Boston, Massachusetts, US

Wrote publications for internal and external audiences. Implemented an Ambassador Program for UMD Alumni. Coordinated multiple administrative and student offices on campus. Scheduled meetings, created focus groups to complete the creation of the Ambassador's Program, and used

Assisted a physician in a research project focusing on the Chronic Fatigue Syndrome. Created surveys for patients and compiled the data and test results into a Microsoft Excel database for analysis. Worked with SmithKline Laboratories to order and review patient tests.

Master Of Science, Regulatory Affairs

Mini-Mba In Biopharma Innovation

Juris Doctor (J.D.)

Certificate For Pathways In Clinical Research

Bachelor Of Science, Biology

Education record