Jessica Frick Email & Phone Number

Clayton, NC, US

Morrisville, North Carolina, US

• Lead regulatory strategy and oversee preparation of dossier content for US and EU regulatory submissions (IND/NDA/BLA/Drug Dossier) and meeting briefing books for regulatory authorities.
• Lead and attend meetings with regulatory authorities and respond to information requests received in submissions
• Perform regulatory review of submission documents and source documents to ensure compliance with regulatory requirements.
• Provide mentorship and development opportunities to the Regulatory Affairs team as part of cross-functional projects or as direct reports.
• Participate in product development teams as regulatory SME; directly support and provide subject matter expertise related to all disciplines of Regulatory Affairs, but not limited to clinical, nonclinical.
• Conduct Lead gap assessments of regulatory submissions, clinical data, nonclinical data, and other technical documentation against industry regulations and standards (US/EU/ROW).

Cambridge, Cambridgeshire, GB

• Responsible for managing cross functional drug development teams to achieve key regulatory deliverables such as IND submissions and RFI responses
• Coordinate between clinical and up to 30 local country regulatory representatives to plan and distribute CTA submissions
• Strategize and execute the distribution of drug specific documents such as DSUR and IB for more than 30 studies with submissions in over 45 countries
• Conduct all study closeout activities related to regulatory such as TMF completion and QC, contribute to CSR finalization, and coordinated all necessary submissions
• Train new colleagues that were starting in a new position on everything from the basics of regulatory to the specific ways of working of the company
• Supported Global Regulatory Leads in the filing and amending of iPSP and PIP plans

Morristown, New Jersey, US

• Serve as a regulatory representative at meetings with the FDA: coordinate review and submission of meeting requests and briefing books, coordinate cross-functional team prep meetings, and take minutes during the FDA.
• Assist with submissions to INDs, NDAs, MAAs and support project development plans and timelines
• Regulatory representative for drafting/review of safety documents such as IB, PBRER, and DSUR
• Assist in the creation and revision of different Investigational Medicinal Product Dossiers (IMPDs)
• Coordinate responses and serve as the regulatory reviewer for any queries received from Health Agencies related to global CTAs and any RFIs received through INDs and NDAs
• Coordinate filing of regulatory documents in to multiple EDMS systems (including Veeva, Trial Interactive/PPG, Wingspan, etc.)

• Assist with document preparation for original CTA and CTA amendment submissions in over 30 countries globally
• Submit study registration and results to online registries such as ct.gov
• Provide administrative support and coordination with CROs for global submissions across studies
• Assist in the creation and revision of different Investigational Medicinal Product Dossiers (IMPDs)
• Represent Regulatory Affairs in team meetings with both the CROs and throughout the company
• Coordinate filing of regulatory documents in to multiple EDMS systems (including Veeva, Trial Interactive/PPG, Wingspan, etc.)

San Diego, CA, US

• Revise study documents (protocol, ICF, IB) and submit to appropriate regulatory committees such as FDA, MHRA, and HRA REC
• Manages external consultants including contract research organizations (CROs), imaging vendors, central lab vendors, and Clinical Research Assistants (CRAs)
• Prepares and reviews all applicable documents required for the conduct of the study (Statistical Analysis Plan, Clinical Management Plan, Trial Master File, etc.)
• Manages the clinical trial budgets along with reviewing/approving vendor and site payments
• Operational management and oversight of phase 1 and 2 oncology clinical trials
• Perform remote and on-site monitoring of patient medical records, regulatory files, and IP accountability

Boston, MA, US

• The Center for Immune-Oncology
• Prepare and submit all new protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
• Maintain regulatory trial master files for each assigned study in compliance with study sponsor requirement
• Assist in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, Industry Sponsors, and third party auditors.
• Preparation of regulatory documentation, including but not limited to; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug.
• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed

Boston, MA, US

• The Center for Immune-Oncology
• Responsible for data reporting and management, collection of source documents, adverse events reporting, filing and archiving of study records, and resolution of data queries
• Interact with study participants as directed/required by the protocol and/or study team
• Ensure all study related samples are collected, prepared and shipped according to the protocol requirements and IATA regulations
• Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, and applicable protocol training
• Closeout of clinical trials, including audit preparation and communication with regulatory agencies

Cambridge, Cambridgeshire, GB

Crystallization-free crystallography for structure elucidation of small molecule drugsExperimenting with various solvents to synthesize different crystalline spongesDetermine chemical composition, molecular conformation, and absolute configuration for small molecule compounds

Hamden, Connecticut, US

• Lab setup for chemistry department following Standard Operating Procedures
• Ensure proper sterilization and storage of glassware and experimental techniques

Hamden, Connecticut, US

• Independent research with minimal supervision
• Collected, tested, analyzed and labeled samples for water analysis using GC/MS
• Experience in the scientific collection, testing, analysis and quality control of production samples.
• Adept in detecting, diagnosing and contributing to the resolution of flaws and impediments in the samples
• Consistently adhere to Good Laboratory Practice as well as safety protocols

Master Of Science (M.S.), Clinical Research

Bachelor Of Science (B.S.), Chemistry

Diploma, General