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 Other Key Contracts in the Life Sciences (RGA 6431)- Clinical Trial Design Optimization (BTC 6213)www.cps.neu.edu/degree-programs/graduate/masters-degrees/masters-regulatory-affairs.phphttp://catalog.northeastern.edu/course-descriptions/rga/

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, scientific advisory board agreements, data safety monitoring board agreements, material transfer agreements, sponsored research agreements, confidentiality agreements, supply agreements, commercial agreements, software agreements and lease agreements, as well as review all clinical trial HIPAA/Informed Consent Forms.• 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 and external accounting and legal teams.• 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.• Manage the intellectual property portfolio/filing deadlines and the licensing portfolio.• Review press releases, investor presentations and stockholder communications.• Worked with outside counsel and the transfer agent on a reverse stock split.• Manage the legal entity requirements for all subsidiaries.• Work regularly with a variety of outside counsel for the various issues and areas that need to be managed.• Work closely with the company’s regulatory and clinical department, business development/strategy team, finance/accounting team, human resources and executive management.

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 evaluating safety and pharmacokinetics:o Metastatic Melanoma (Phase I)o Prostate Cancer (Phase I)o Unresectable nueroendocrine tumors (Phase I)o Pheochromocytoma/Paraganglioma clinical trial (Phase II)• 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 Procedures (SOPs)o Clinical Monitoring Plan (CMP) o Clinical Administrative Manual o Informed Consent Forms for individual Institutional Review Boards (IRBs). o Case Report Forms and supporting industry-developed source documentso Clinical monitoring site visit reports• 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 for the duration of the clinical study at all identified and/or participating sites.

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 I-IV and medical device feasibility and pivotal trials.o Therapeutic areas include:• Cardiovascular Disease• Oncology• Nephrology• Gastroenterology • Spinal Surgery• Responsible for the accuracy of case report forms (CRF’s) at each research site for a particular study and to ensure each site follows Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Responsible for preparing for and conducting Site Qualification Visits, Site Initiation Visits, Site Interim Monitoring Visits and Site Close Out Visits.• Responsible for timely site communication (i.e. site confirmation visit letters, site follow-up letters, site visit reports)• Responsible for communication, overall management, and timely submission to foreign governing bodies for international approval to conduct research trials.o Foreign countries include:• Poland• Germany

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 to support their patient's enrollment in various studies. Develop source documents for clinical trials per protocol and design case report forms to ensure that all relevant data items are captured as specified by the protocol to ensure that the data collected supports the protocol objectives. Coordinate with the CRA (Clinical Research Associate) to organize and manage numerous clinical trials in the division of cardiovascular and vascular medicine research. Responsible for signing-off on transmittal's and entering CRF data, responding to queries, and completing DCF's. Manage the protocol deviation log, protocol amendments filing and serious adverse events filing. Responsible for maintaining and updating various website postings and other advertisements of all research studies and ensuring all clinical research material is IRB approved.

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 of management at multiple branch conversions.

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