Chrystal Jackson

• Provide Regulatory Operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of US Advertising and Promotion materials in accordance with business goals and objectives.
• Lead effective communications with reviewers residing at the US FDA Division of Drug Marketing, Advertising and Communications (DDMAC) to expedite resolution of issues relating to assigned products.
• Ensure changes in US prescribing information are reflected in current Promotion and Advertising material.
• Participate in company working groups on Advertising and Promotion standards and guidelines.
• Maintain quality system which supports Advertising and Promotion Regulatory requirements.

• Representing Regulatory Affairs in support of GSK products for launch, Copy Approval Meetings and all submissions or communications to the FDA.
• Responsible for integration activities pertaining to non-GSK applications needing to be inactivated or withdrawn.
• Trained GSK personnel new global database.
• Reviewed clinical SOPs that cross over into regulatory.
• Creation and review of Annual Reports pertaining to GSK products.

• Major participation on SWAT teams (member and tester) for the evaluation of GSK eCTD software.
• Development of excel tool which enabled management to capture metrics, analyze resources and perform graphic presentations across all three GSK sites.
• Worked with Major Submission Publishing to evaluate outsourcing of eIND/BLA submissions. This included streamlining across-site consistency of current LCM processes.
• Participation in pilot teams to evaluate the use of the electronic secure gateway for electronic submission to the Agency.
• Provided Managerial responsibilities pertaining to interviewing and hiring of staff.
• Duties also included ensuring up-to-date records, coordination of education and ensurance of staff certification on validated systems.
• Addressed all questions posed by staff and other GSK personnel.
• Met with other GSK managerial staff in the prevention of submission delays, quality of submission results; maintaining site metrics and ensuring staff assistance in the metric maintenace pertaining to other GSK sites.
• signing off on various submissions for Therapeutic Reps when needed.
• Ensured staff were kept informed of issues/events/new SOPs/Guidances that could/would impact their work activities.
• Attendance at LCM managerial meetings to evaluate resources and workload.

• Creation, maintenance and scheduling of databases for both Drug and Vaccine submissions.
• Duties included: database presentations; integration of US databases with Belgium's web interface to provide continual accurate submission communication abroad.
• Transitioning of remaining manual products [i.e. BB-INDs, pre-INDs, Master Files, several Annual Reports] over to an electronic environment.
• Additional responsibilities included: providing standard Training to US Regulatory Vaccine and Pharma staff; leading team explorations pertaining to current practices.

• Initiated and ensured the critical review and quality assurance of all technical reports for accuracy and internal consistency which included identifying potential regulatory issues; dependently coordinating the preparation of all sections of INDs, PLAs/BLAs/ELAs and their amendments/supplements.
• As assigned, prepare written first draft of SB strategies, positions, and replies to FDA and other Regulatory customers.
• Attended, participated and took lead regulatory role in promotional copy approval meetings.
• Create and submit the Summary Basis of Approval for the vaccine products undergoing FDA approval.
• Created the regulatory steps for submitting information to the FDA under 401 FDAMA and working with legal to create an SOP for regulatory to follow pertaining to this type of submission.
• Assisting and attending the Advisory Committee Meetings. Duties included: assisting in the creation and review of AdCom documents (briefing documents, Q&A tables, slide presentations); detailed note-taking; providing feedback to team members.
• providing the template for creation and maintenance of a vaccine database for housing all materials relevant to biologics/vaccine submissions.
• Reviewed and kept abreast of professional/trade literature.
• maintained principal responsibility for day-to-day activities related to assigned projects (e.g. status of clinical investigators and studies, review of documentation for release of investigational supplies, etc.)
• Additional duties included: representing USRA on interdepartmental committees; training new Regulatory Associates on procedural, process and review requirements for submissions.
• Supervised and trained temporary or less experienced staff for major submissions and other special projects.

• Researched, developed and prepared written replies to medical inquiries related to SB products, competitive products and miscellaneous topics.
• Created new form letters and update existing form letters to address new issues or information pertaining to GSK and/or competitive products as directed by the Drug Information Manager.
• Critically evaluated published data and data on file to determine scientific validity.
• Responded to complicated telephone queries including handling special case phone calls, product tampering, legal and adverse experience issues as defined in the Product Information Department’s standard of procedures.
• Coordinated communications with various departments as necessary.
• Maintained and enhanced technical skills -searching scientific literature and other appropriate resources for information to answer inquires as related to GSK products, competitive products and miscellaneous topics.
• Attendance at sales training overviews and various internal and external educational seminars.
• Handled majority of spontaneous adverse experience telephone reports received by GSK with the completion of all appropriate forms and paperwork.

All duties described for Worldwide Product Safety Associate with the following additions:

• Instruct Associates in the performance of their duties.
• Prepare Worldwide Information analysts to obtain the promotional step to Reporting Associate.
• Approve absences and other time related issues.
• Complete accurate performance reviews of those Associates/Analyst reporting to me.
• Review all quarterly and annual periodic reports prior to their submission to the FDA.
• Review of expedite materials prior to their submissions to the FDA.

• Determined, on the basis of GSK policy, the expedite or periodic classification of each adverse experience contained in reports involving GSK marketed drug products or vaccines.
• Prepared Form FDA-1639’s for the reporting of adverse experiences pertaining to GSK marketed products for inclusion into ’s NDA Periodic Safety reports.
• Prepared Form FDA-1639s and compiled appropriate supporting documents for each 15-day alert report needing to be submitted to FDA within 15 working days of receipt at GSK. .
• Created follow-up correspondence to physicians and other reporters regarding adverse experience reports for GSK U.S. marketed drug products or vaccines.
• Assessed the need for consultation with GSK, U.S. Medical Affairs physicians (North America), GSK physicians (SK-Biologicals), or with the Manager (Product Safety Reporting), concerning the adequacy of follow-up information received from medical personnel or other reporters in terms of close-out of an adverse experience file.

• Produced ad hoc Adverse Experience reports.
• Produced standardized Adverse Experience reports in accordance with established time schedule.
• Ensured integrity of ADE database via quality assurance procedure.
• Perform maintenance and programming of multiple computer database dictionaries.
• Reviewed, abstracted, code summarized and performed data entry of Adverse Experience case information.