Medical Management
Resume:
Cinderella Lessman
Fort Collins, Colorado 80526
***********@*******.***
Professional Work Experience:
**/****- **/**** **. Clinical Specialist & Regulatory Affairs
. Developed regulatory strategy for conducting clinical and
bioequivalence studies, for ophthalmic drugs and coordinated the
clinical studies with the identified Contract Research Organization
(CRO). Assembled the required eCTD and 510K submissions.
. Executed and managed submissions such as US FDA Section 510(k)
Notifications, Pre-market Approval (PMA) Applications and Supplements,
EU IVDD Technical Documentation, and global product registrations.
. Participated and conducted Internal Audits.
. Participated in third party audits of the Quality Management System and
assist in the development of responses to support audit corrections and
rebuttals.
. Reviewed change control documents and ascertain Regulatory impact for
external and internal documents.
. Coordinated the notarization and legalization of regulatory documents.
. Maintained external references and lists of national and international
regulations, standards and FDA guidance documents that affect the
products and operations.
. Assisted in development/maintenance of regulatory files, records and
reporting systems of systematic retrieval of information.
. Provided support for the regulatory department to ensure efficient and
compliant business processes and environment. Assisted in preparing and
submitting documentation needed for registration worldwide.
. Identified and resolved patent application filing issues (e.g.
resolving translation delays, locating missing inventors, drafting
documentation to correct assignee and assignor changes.
* Drafted and forwarded correspondence to our foreign agents based on
advanced knowledge of country patent laws and requirements.
* Prepared and filed Demands for Preliminary Examination based on
knowledge of rules and requirements set forth under the Patent
Cooperation Treaty; timely filing the same with the European Patent
Office to meet the deadline and maintain patent rights.
- Performed transcriptional data verification of technical reports and
other documents, following corporate Standard Operating Procedures.
- Entered documents into corporate quality databases, checking for
completion and correctness.
- Gathered documents and materials, collates, distributes and/or files.
- Entered and distribute documents and forms.
- Data processing support to include maintaining database for all
documentation.
- Audited reports and files for discrepancies.
- Compiled information and metrics from various documents and databases.
- Provided guidance and refer staff members to appropriate contacts.
- Coordinated and managed multiple documents and team members through the
document review and approval process following corporate SOPs.
Regulatory history, guidelines, policies, standards, practices,
requirements and precedents.
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial
trade requirements, agreements and considerations.
Domestic and international regulatory guidelines, policies and
regulations
Ethical guidelines of the regulatory profession, clinical research
and regulatory process
Extensive experience in the pharmaceutical industry in leadership
and hands-on roles in the areas of:
o CMC data/documents.
o IND / NDA / ANDA/510K data and text documents / sections.
o Clinical regulatory affairs documents/data for human prescription
drugs (proprietary and generic).
o Review of human Rx drug promotional labeling and advertising and
drug product labeling.
Highly motivated individual who successfully implements regulatory
tactical objectives by effective communication with the FDA and across
companies' functional units (including Clinical.
Well-versed in the following therapeutic areas: central nervous
system (CNS), anti-infective, antihypertensive, cardio-renal, gastro-
intestinal, endocrine, and anti-inflammatory/analgesic.
Thorough knowledge of FDA and ICH regulations in Rx drug
development.
Liaison with FDA relating to INDs, NDAs, 510Ks and ANDAs.
Directed and supervised regulatory affairs' life-cycle management
(compliance) activities for dozens of marketed license applications
(NDAs / ANDAs) that were approved for drug products with the following
administration routes: oral (solids, liquids and suspensions),
intravenous, ophthalmic and topical.
Proven track record in developing strategic labeling and
promotional materials that resulted in successful product launches for
6 companies.
Reviewed and was the regulatory signatory for hundreds of
promotional pieces (solely and in compliance team settings involving
direct interactions with the ad agencies).
o Developed the labeling for several Rx drug products.
Direct interactions (face-to-face and telephone) with DDMAC.
. Supported NDA, ANDA, IND, CBE30, IDE, PMA-S and 510K documents and
filings.
Lead preparation, reviews, and regulatory submissions.
Identified regulatory requirements for changes to existing products.
. Composed, compiled and produced routine regulatory communications, such
as registrations,
certificates and reports, utilizing text, data and graphics programs
and involving database searching, and outside document retrieval.
. Prepared/maintained regulatory submissions to FDA, notified body and
other agencies. Including, but not limited to, preparation of
submission documentation for obtaining and maintaining medical device
approvals around the world: 510k, PMA, PMA Supplements, 30-Day Notices,
device technical files, Change Notices to the Notified body.
. Prepared and maintenance of standard operating procedures for
regulatory affairs processes.
. Maintenance and audit of the device tracking database per 21CFR821
. Followed procedures to assure confidentiality of patient information.
. Assisted with preparation for audits, quality reports and
correspondence.
. Wrote regulatory procedural documents within the company's quality
management system, where needed.
. Maintained registration files, schedules and payment records
. Prepared and maintained technical files/design dossiers for products,
suitable for submission to regulatory agencies.
. Prepared, writings, coordination, and interactively following up on
global product submissions.
. Reviewed product labeling, product claims, advertising, specifications,
and changes for regulatory compliance.
. Partnered with GMP associates to create and implement worldwide
regulatory strategies.
. Served as a catalyst for the implementation of enhanced regulatory
practices within the GMP business
. Represented Regulatory Affairs in quality-system audits by external
agencies
. Assisted with post-market compliance requirements
. Prepared documentation for Clinical Studies and coordinated and
maintain study communications.
. Reviewed significant product and clinical study submissions with
management and negotiated submission issues with agency personnel.
. Provided support to currently-marketed products as necessary by
reviewing labeling, promotional materials, and product and
documentation changes per policy and procedure.
. Interacted directly with the FDA and indirectly with international
regulatory agencies on most products/projects at reviewer level; all
significant issues was reviewed with management.
. Supported regulatory compliance activities, including manufacturing
site registration, GMP, Notified Body audit, post market vigilance
reporting, product recalls, etc.
. Maintained proficiency in worldwide regulatory requirements;
established and maintained positive relationships with agency
personnel.
. Provided business and product information to international regulatory
staffs to enable development of strategies and requirements, and
communicate that information to management.
. Provided feedback and on-going support to product development teams
for regulatory issues and questions.
Authored and submitted PMA supplements (30-day Notice, Real-Time Reviews,
180-Day Supplements, Annual Reports). Reviewed/approval of engineering
study protocols/reports and validation study protocols/reports. Reviewed
and approval of manufacturing changes for Class III implantable medical
devices. Recent experience with Class III implantable medical devices;
Proven successful track record of authoring/submission/approval of Class
III implantable PMA supplements; knowledge of FDA PMA guidance documents
and CFR regulations.
Improved quality of monitoring and data by developing and training clinical
site managers and contract monitors in GCP, FDA regulation, and AE/SAE
reporting. Ensured a field/site FDA audit with no observations through
consulting with data management in the development and presentation of a
program to train a consultant group to protocol and case report forms for
auditing and monitoring purposes to achieve compliance with protocols, GCP,
and federal guidelines.
Key contributor to regulatory filings including Investigational New Drug
Applications (INDs), Clinical Trial Applications (CTAs), protocols, and
Clinical Study Reports (CSRs).
Performed quality control (QC) review of clinical, pre-clinical, and
pharmacovigilance documents prepared as global regulatory submissions.
Wrote reviews and edited IND annual reports.
Adjusted Quality/Regulatory systems to insure conformance with established
standards of performance. Actively participated in projects as the quality
control subject matter expert in the modification and improvement of
standards from both a quality and regulatory perspective.
Ensured compliance with FDA and GCP guidelines that resulted with an in-
house FDA audit with no observations by developing complete set of SOPs and
full range of monitoring forms (from site qualification to site closeout).
Streamlined site monitoring by collaborating with director of data
management to test and implement Clindex monitoring tools.
02/1998 to 03/2001 Regulatory Affairs Associate
NCMConsulting
Starnberg, Germany
. Managed all Clinical, Bioavailability and Bioequivalence studies for
Client Products
. Experience with Class III devices. Relevant experience includes,
interventional cardiology, stents, implantable device, catheter
delivery systems, orthopedics, cardiac surgery, heart valves PMA
devices.
. Experience in preparing domestic and international product submissions
. Coordinated preparation of clinical labeling and shipment of product to
CRO.
. Reviewed/wrote BE study reports and assembled the clinical sections of
eCTD submissions of ANDA/NDA/510K
Planned and managed regulatory submissions to government authorities, while
providing leadership within the regulatory affairs department to ensure
timely filing and approval. Was responsible for handling regulatory
activities within matrixes, multi-site environment, and for continued
interaction between the business and agents of the US Food and Drug
Administration.
Managed and approved strategic regulatory guidance for Pain Management in
abuse deterrents and various Therapeutics areas.
Developed regulatory strategies for several post-marketing supplements
(ANDAs and NDAs) including but not limited to labeling and manufacturing
site changes (drug substances and drug products).
Performed due diligence on many products, across various therapeutic
areas on behalf of the company's clients within established timelines.
Provided regulatory guidance to ensure all post-marketing activities
associated with the company's product is in compliance with FDA's
regulations and guidance's.
Provided regulatory strategies and communications to FDA in response to
CMC deficiencies relating to a manufacturing supplement for an enhanced
safety feature for the company's sole product that was approved.
Approved all regulatory submissions prior to filing,
managed the department budget, ensured compliance with
global regulatory requirements as it pertained to its
clinical trials, marketed products regulatory commitments;
this included but was not limited to;
INDs, NDAs, 510Ks, MAAs etc., supplements,
amendments, annual reports, advertising and promotional materials.
Worked closely with the management of the QA department to ensure
regulatory compliance.
Assisted in the creation of standard clinical research
documents by preparing, writing INDs, 510Ks, NDAs and post-approval
documents.
Contributed to contract success by overseeing CRF filing
and ensuring compliance with protocols and regulations.
01/1992 to 02/1998 Medical Science Liaison
NCMConsulting
Starnberg, Germany
. Identified, established and maintained collaborative relationships with
key investigators and institutions strategic to product development.
. Developed, and maintained collaborative relationships with current and
future industry leaders to identify scientific communication
opportunities including abstracts and manuscripts.
. Managed research and educational activities at targeted institutions with
industry leaders and other key decision makers.
. Participated in medical education for healthcare professionals through
presentations at investigator meeting, advisory boards, and other
appropriate venues to enhance product knowledge.
. Maintained clinical expertise through aggressive education including
attendance at relevant symposium, scientific workshops, preceptorships,
and review of key journals. Job Description within Medical & Scientific
Affairs, the Medical Scientific Liaison (MSL) position functions as a
scientific liaison between NNI and key external customers to further
scientific exchange and to gather insight into therapeutic ideas. S/he
provides product and field scientific support to Medical, Sales and
Marketing, as well as Managed Care and Government by using academic
credentials and scientific expertise to communicate with health care
providers and organizations.
External relationships included: physicians; nurses; nurse practitioners;
pharmacists; academic institutions; associations/societies; managed care
organizations and HMOs.
Education and Certification:
1974 Bachelors of Science
Jackson State University
Jackson, MS, USA
1982 Medical Research/ Regulatory Affairs Program
University of Colorado Health Science Center
Denver, CO, USA
1976 Molecular Biology/Regulatory Affairs Program
University of California Irvine
Irvine, California, USA
2003 Medical Research/Regulatory Affairs Program
University of Munich
Munich, Germany
2012 Regulatory Affairs Certification Program
Colorado State University
Fort Collins, Colorado
2007 Association of Clinical Research Professionals
2007 Drug Information Association
2003 Regulatory Affairs Professional Society (RAPS)
2001 Society Pharmacology and Therapeutics
2000 Association of Consultants of the Bioscience Industry
1998 American Federation of Clinical Research
FOREIGN LANGUAGES
Fluent in Germany
SUMMARY OF THERAPEUTIC EXPERIENCE
Class I-III Medical Devices, Biologics, Pharmaceutical Drug, Ophthalmology
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