FRANCES (FRAN) C. DANIEL, MPH

**** *. ******* ***** ****, #1015 mobile phone: 240-***-****

Silver Spring, MD 20906 email: ac4a00@r.postjobfree.com

LinkedIn: https://www.linkedin.com/in/fran-daniel-96a2414/

CAREER SUMMARY

My career as a medical and scientific professional demonstrates expertise in medical writing including inflammatory diseases (inflammatory bowel disease, rheumatoid arthritis, psoriasis, and psoriatic arthritis), oncology, hematology, and dermatology, for continuing medical education (CME), pharmaceutical industry, and professional meetings. I have an advanced understanding of needs assessments, gap analysis, medical letters, drug development, and the importance of patient advocacy. My expertise includes accomplishments in Food and Drug Administration processes; standard operating procedures, clinical research administration; public health program management, medical writing/editing, translating scientific/medical language for consumers to plain language.

AREAS OF EXPERTISE and ACCOMPLISHMENTS

Medical Writing and Editing

Years’ Experience: 10 (5 medical, pharmacy, nursing education companies; 4.0 pharmaceutical industry; 2.0 home-based including managed care system)

Major Accomplishments:

Developed first drafts of slides, monographs, journal articles, journal club discussions, and scripts for CME activities for gastroenterology, psoriasis, psoriatic arthritis, rheumatoid arthritis, epilepsy, and migraines

Researched and developed proposals (needs assessments, gap analysis evidence, learning objectives, and outcomes) for CME activities

Acted as liaison between nine collaborators and program; researched and developed the Response for Proposal (RFP) for CS2Day tobacco cessation grant with nine collaborators for largest approved CME grant at $12 million; CS2Day focused on educating physicians (specifically, cardiologists and psychiatrists) how to support their patients in tobacco cessation; this initiative included nine partners across the U.S.

Investigated and created medical responses, developed the medical portion of the formulary submission document, created SOPs, consumer FAQs

Translated scientific and medical language for consumer/plain language audience

Developed “Good Documentation” course used to train new employees at large pharmaceutical company

Evaluated, researched, and created insulin and technical documents

Researched and implemented CME proposals, developed needs assessments (gap analysis, evidence, learning objectives)

Analyzed and developed FDA guidelines, scientific meeting minutes, and Quick Review reports

Outreach to Minority Populations and Patient Advocacy

Major Accomplishments:

Researched and developed medical responses on diabetes that disproportionally affects minority patients

Coordinated with Hepatitis B Foundation to develop patient education module on hepatitis B, focusing on Asian-Americans and African Americans with hepatitis B

Volunteered on the Navajo Indian Reservation for a summer

Developed programs focused on women’s health outcomes: osteoporosis, rheumatoid arthritis, and breast cancer prevention clinical trials

Coordinated tobacco education data collection focused on African Americans

Collaborated with WEGO Patient Advocates to include their perspective in needs assessments and CME activities via survey and audio responses

Ensured inclusion of patient voice in needs assessments/gap analysis to illustrate how clinician knowledge/competence/performance gaps affect patient outcomes

Translated scientific language into plain language for patient FAQs and patient education

Clinical Research

Years’ Experience: 6 (2 years private practice, 4 years academia)

Major Accomplishments:

Trained, coached and evaluated oncology clinical research professionals on adverse event identification and reporting to ensure patient safety; trained and implemented informed consent process to ensure compliance with ICH/GCP regulations for oncology clinical trials

Managed Phase I-III oncology clinical trial processes with direct patient contact including recruitment, inclusion/exclusion criteria, informed consent, scheduling and milestone management, identification and reporting of adverse events, and follow-up in compliance with ICH/GCP guidelines to successfully manage patients through clinical trial process and report adverse events. Specialized in leukemia and lymphoma clinical trials.

FDA Regulatory Guidelines

Years’ Experience: 10 years, 9 months total; 6 years (clinical research); 4 years (major pharmaceutical company); 9 months (FDA)

Major Accomplishments:

Successful evaluation, development, and approval of 510(k) guidance’s for in vitro diagnostic devices, notices of availability, and final rules for accuracy in preparation for marketing of 510(k) devices for publication in the Federal Register

Development of guidelines, notices, and final rules included level one, level two, and special controls guidelines

Developed meeting minutes and action plans from meetings between FDA and pharmaceutical/device companies to achieve key action items, deadlines, and communications for more complete submissions and resource efficiencies

Analyzed the Unique Device Identifier (UDI) rule for key issues and patient safety; began an effort to create an informational package to inform FDA device employees about key issues

Acted as liaison between clinical research outreach nurses and physician practice; trained and implemented education for clinical research nurses and data managers on Good Clinical Practice (GCP) compliance to identify and report adverse events to ensure patient safety; implement informed consent process compliant with GCP guidelines

Public Health Program Management

Years’ Experience: 6.9 (4.0 pharmaceutical industry, 2.0 years academia, 9 months FDA)

Major Accomplishments:

Acted as liaison and administered and evaluated all aspects of teen smoking CDC grant; collaborated with school administrators, conducted focus groups with teens, collected and analyzed data, and managed grant budget; messages were utilized by the CDC in tobacco education programs

Video-taped and mapped tobacco, alcohol, and lottery billboards in the St. Louis area; data from this project to the Missouri Legislature was instrumental in banning these billboards in Missouri

Acted as liaison between scientific reviewers and management for the Quick Review Pilot; created Quick Review Pilot metric tracking system for FDA to ensure accurate and complete reporting to ensure successful initiation of Quick Review Pilot that encourages successful and efficient clearance of applications; because of close follow-up with scientific reviewers enabled FDA to communicate with industry where improvements can be made to increase application clearance

Led working group as liaison (health outcomes, business-to-business, marketing, procurement, and medical information) that transitioned major pharmaceutical company to AMCP formulary guidelines at major pharmaceutical company

Managed and implemented education program to prevent violence in rural pregnant teens; liaison between pregnant teens and program

Analyzed the Unique Device Identifier (UDI) rule for key issues and patient safety; began effort to create an informational package to inform FDA device employees about key issues

SECURITY CLEARANCE

Public Trust Clearance 2011-present

TECHNOLOGY SKILLS

MS Word Excel PowerPoint Visio Outlook

Electronic case report forms

Electronic data bases for documentation of responses and adverse event reports

PROFESSIONAL EXPERIENCE

Managed Care Systems 8/2017-present

Medical Writer/Editor

Home-based

Analyze content of standard operating procedures for accuracy, clarity, consistency, and grammar for managed care system

Revise content, clarity, and grammar of standard operating procedures regarding claims, appeals, confidentiality for managed care system

Imedex, LLC 5/2016-8/2017

Physician Education Company

Medical Writer

Home-based

Investigate and create physician continuing medical education (CME) proposals (needs assessments, gap analysis, evidence, learning objectives) for U.S. and European CME activities

Coordinate expert interviews with faculty for on-line activities

Train and orient new medical writers

Create outcomes and audience response system questions

Evaluate outcomes reports for medical accuracy

Develop landscape documents to track approved and pipeline products for planning and business development purposes

Garner highlights from major meetings for future activities

Outcomes:

Train and orient new medical writers

Establish landscape documents for therapeutic areas

Recommend faculty relationship strategies

CME Outfitters, LLC 1/2014-5/2016

Medical Program Director

Home-based

Research and develop physician continuing medical education (CME) proposals (needs assessments, gap analysis evidence, learning objectives)

Act as liaison for physician faculty; collaborate with physician faculty to develop activity content; select faculty; plan faculty agendas; lead faculty planning calls

Write first drafts of slides, articles, monographs, and scripts for CME activities

Perform extensive scientific review of slides, monographs, and articles

Apply subject matter expertise to proposals and activity content

Develop patient education module for patients with hepatitis B virus infection

Translate scientific/medical language for consumer or plain language audience for hepatitis B activities; utilize Plain Language Thesaurus for Health Communications

Developed expertise in hepatitis B and C, inflammatory bowel diseases (ulcerative colitis, Crohn’s disease), epilepsy, multiple sclerosis, insomnia, rheumatoid arthritis, obesity, psoriasis, and psoriatic arthritis

Outcomes:

•Awarded >$4 million in grants in two years for activities on clinician and patient education for hepatitis B, DecisionSim activity on psoriasis, ulcerative colitis, GERD, psoriatic arthritis, opioid-induced constipation, psoriatic arthritis

•Awarded $100k over requested funding for psoriasis DecisionSim activity

•Researched and developed hepatitis B patient education module with Hepatitis B Foundation

•Collaborated with WEGO patient advocates to include patient perspective in needs assessments and CME activities

Food and Drug Administration 1/2012-9/2012

Public Health Analyst

Silver Spring, MD

Evaluated and developed guidances on obtaining marketing clearance via 510(k) for in vitro diagnostic devices, notices of availability, and final rules for accuracy in preparation for publication in the Federal Register; guidances, notices, and final rules included level one, level two, and special controls guidances

Initiated tracking project for the Quick Review Pilot in Excel®

Developed monthly reports on Quick Review Pilot metrics submitted to senior management

Documentation and creation of meeting minutes with action plan that includes industry involving discussion points, areas of agreement and disagreement, items requiring further discussion, and action items

Analyzed the Unique Device Identifier (UDI) rule for key issues and began an effort to put together an informational package to inform FDA device employees about the key issues identified

Active participant in Center Communication Committee and Quick Start Labeling Committee

Analyzed Quick Review Pilot metrics tracked and 100% enabling FDA to communicate with industry where improvements can be made to increase swifter application clearance

Created accurate and complete meeting minutes and action plans to ensure excellent communication and process improvement between FDA and industry

Outcomes:

Ensured accuracy and compliance of guidances, notices of availability, and final rules for the Code of Federal Regulations for 10 products

Developed Quick Review Pilot metric tracking system to ensure accurate and complete reporting to ensure successful initiation of Quick Review Pilot that encourages successful and swift clearance of applications

Created accurate and complete meeting minutes and action plans to ensure excellent communication and process improvement between FDA and industry

CME Enterprise, Carmel, IN 8/2007-2/2009

Medical Education Content Specialist/Coordinator

Researched and developed proposals in response to RFPs and implemented activities for major pharmaceutical companies’ physician education CME activities including CS2Day smoking cessation, anti-platelet therapy, rheumatoid arthritis, home infusion, and dermal filler techniques

Outcome:

Researched and developed the Response for Proposal (RFP) for CS2Day tobacco cessation grant with nine collaborators for largest approved CME grant at $12 million

CS2Day focused on educating physicians (specifically, cardiologists and psychiatrists) how to support their patients in tobacco cessation; this initiative included nine partners across the U.S.

Leveraged adult learning principles and innovative education methods to engage physicians including interactive on-line case studies, debates, symposia, 3-dimensional graphics

Increased physician participation in educational activities

Utilized gap analysis to develop learning objectives, activities, and evaluation methods that address the education gap and promote compliance with professional guidelines

Ice Miller Business and Legal Advisors 1/2006-11/2006

Indianapolis, IN

Drug and Device Paralegal

Developed medical chronologies by analyzing medical records in preparation for trial

Created chronology of changes in Package Inserts

Eli Lilly and Company, Indianapolis, IN 6/2005-11/2005

Quality Assurance Representative, Global Patient Safety

Established SOPs and library according to Good Manufacturing Practice

Successfully completed GMP training

7/2001-6/2005

Medical Information Associate, US Medical Division

Partnered with physicians and attorneys to develop medical responses, formulary submission document, and consumer FAQs for US launch of Forteo by extracting data from the IND (ISS, ISE), clinical study reports, and investigator brochure to ensure accurate medical content

Translated scientific/medical language for consumer or plain language audience

Outcomes:

40 medical responses created for US launch

Created formulary submission document for US launch

Translated medical information into consumer/plain language FAQs

Led cross-functional team to transition and evaluate new formulary guidelines (Association for Managed Care Pharmacies template) including planning, developing SOPs, and integrating corporate policies for AMCP template and training

Contracted, Temporary Positions

Medical Writer/Editor

DiabetesDigest.com 2013-2014

Jonathan Jarashow, Publisher

Research, develop, and edit consumer articles for diabetesdigest.com specializing in diabetes topics

Senior Medical Editor

RTC Relationship Marketing 4/2013-1/2014

Washington, DC

Verified and edited medical content for website for organ transplantation, bipolar disorder, schizophrenia, and hepatitis C drug launch from 300-page manuscript

Medical Writer

Avram Mack, MD 2/2013-1/2014

Georgetown University School of Medicine

Washington, DC

Edited slides for grammar, spelling, clarity

Verified and revised medical content for seven book chapters on addiction

Medical Writer

Reagan-Udall Foundation, Washington DC 10/2011-1/2012

Documentation of meeting minutes and preparation of meeting minutes for tyrosine kinase inhibitors and cardiac toxicity project

Medical Writer

Medical Communications Consultants, Rockville, MD 01/2011-6/2011

Evaluated, researched, and revised insulin technical documents for large pharmaceutical company

Scientific Writer

Capital Consulting Corporation, Rockville, MD 10/2010-12/2010

NIH/NIST/FDA Bio-specimen Fitness-for-Purpose

Quality Assessment and Standards Development Workshop

Analyzed presentations, case study, and discussions; developed and managed action plan for RNA integrity bio-repositories

OTHER PROFESSIONAL EXPERIENCE

Community Cancer Care, Inc., Indianapolis, IN 7/1999-6/2001

Clinical Research Administrator

Supervised and trained clinical research nurses

Evaluated protocols for accrual and logistics

Managed research budget

Project Manager:

Saint Louis University School of Public Health 1994-1996

Administered and evaluated CDC Teens and Smoking Centers grant, violence in rural

Teen pregnancy grant and School of Public Health internship program grant

Adjunct Instructor: St. Louis University Allied Health Professions 1992-1999

Developed curriculum and selected text books

Taught and evaluated students Fundamentals of Clinical Medicine that included pharmacology, medical diagnostics, procedures, and disease states

Clinical Trial Data Manager: Washington U. Medical Center (St. Louis) 1992-1994

Coordinated Phase I, II, and III oncology clinical trials including bone marrow transplant and leukemia

Ensured compliance with GCP guidelines and adverse event identification and reporting

Clinical Trial Data Manager: St. Louis University Medical Center 1990-1992

Coordinated Phase I, II, and III oncology clinical trials including bone marrow transplant and leukemia, ensured compliance with GCP guidelines and adverse event identification and reporting

Prepared for and coordinated audit resulting in 96% compliance

EDUCATION

Indiana University-Purdue University-Indianapolis Indianapolis, IN

Project Management Certificate

Saint Louis University School of Public Health St. Louis, MO

Master’s in Public Health (MPH)

GPA: 4.0 on 4-point scale

Saint Louis University St. Louis, MO

B.S. in Medical Record Administration

GPA: 3.9 on 4-point scale

Indiana University Bloomington, IN

B.A. in Psychology

GPA: 3.0 on 4-point scale

AWARDS

Teamwork Award-AMCP Formulary Submission Document Process

Eli Lilly and Company

2003, 1st Quarter; 2002, 2nd Quarter

Process Improvement Award-Medical Letter Approval Process

Eli Lilly and Company

2002, 4th Quarter

PROFESSIONAL MEMBERSHIPS

American Medical Writer’s Association (AMWA)

April 2010-present

Education Coordinator,

American Medical Writer’s Association Mid-Atlantic Chapter-Bethesda

October 2011-November 2013

Member, American Medical Writers’ Association Mid-Atlantic Chapter

April 2011-present

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