Medical Device
Resume:
Frank Lenous Turner, D.P.M.
P.O.B ****
Warrenton, Va. 20186
Medical Writer –Medical Director
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Primary Contact 540-***-****
PROFESSIONAL SUMMARY:
• Seasoned Medical Writer with 18+ years of experience in the Pharmaceutical /
Biotech Industry.
• Clinical Evaluation Report Writer (CER) for EU medical device directives and
FDA Projects.
• Senior medical writer for USA based and European based medical device
companies for the development of unique device identifier (UDI) for medical
device labels and packages.
• Performed medical writing for medical device companies for their medical device
labelers department who must submit information to the FDA-administered
Global Unique Device Identification Database (GUDID) for regulatory approval.
• Participated in the medical review sessions with medical device companies for
evaluation and interpretation of the rules required for medical device labelers to
include a unique device identifier (UDI) on their medical device labels and
packages.
• Medical Safety Narrative writer (8000+ written) for multiple therapeutic areas for
multiple pharmaceutical and biotechnology companies over the past 27 years.
• Medical writer for therapeutic areas to include cardiovascular, oncology,
infectious disease, ophthalmology, dermatology, podiatry, orthopedics,
respiratory, neurology and endocrinology.
• Medical Writing experience with Phase I, Phase II, Phase III, NDA preparations,
CTD 2.7.1 section, CTD 2.7.2 section and post marketing study phase
documentation.
• Proficient in the independent preparation of Clinical Evaluation Reports (CERs),
Clinical Study Reports (CSRs), Clinical Study Protocols, Informed Consent
Forms, and Investigator Brochures.
• In-depth experience with regulatory writing including, CMC, Previous Human
Use, Clinical Study Protocols, Informed Consents, SOPs, Safety Narratives,
INDs, PSURs, NDAs, regulatory responses, patient safety narratives and other
clinical/regulatory documents.
• Expert-level knowledge of GCP, GLP, ICH, FDA, and EU guidelines and
regulations.
• Scientifically trained in the development of critical needs associated with medical
education-medical affairs departments to include development of unique slide kits
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and seminar manuals. The medical education communication data that I have
written was developed with inclusion of fair balanced objectives, informative data
production for live symposia, advisory boards, roundtable discussions, KOL
seminars and monographs.
• Professionally trained and have acquired a firm understanding of ACCME, OIG
guidelines for continuing medical education and non-CME informational
programs which will be a significant component need for KOL interaction.
• Provided medical education and medical communication leadership for
moderating symposia, pharmaceutical project review committees, advisory
boards, CME and non-CME (CE) programs with KOL’s.
• Proven ability to develop and maintain relationships with thought leaders in
multiple therapeutic disciplines and a medical consultant for several
pharmaceutical companies marketing, education divisions for CME organizations.
• Provided extensive medical writing/medical review for regulatory submission
documents to include: IND, NDA, Safety Narrative, IND, PSURs, CRF, CSR,
Protocols, IBs, PMA, Informed Consents, pre-clinical/clinical study protocols
SOPs, BLAs, MAAs, REMS, Amendments Segments of Annual Reports, CER,
Risk Benefit Assessment documents and clinical study software program
selection.
PROFESSIONAL EXPERIENCE:
Clinical Evaluation Report (CER) Writer Medical Device Company Experience:
Advanced Bionics
BARD
Scholls
Synthes
ETHICON
Senior Consultant Medical Writer
Research Assist 2014 - Present
• Provided extensive medical writing/medical review for regulatory submission
documents IND, NDA, Safety Narrative, IND,PSURs, CRF, CSR, Protocols, IBs,
PMA, Informed Consents, SOPs BLAs, MAAs, REMS, Amendments Segments of
Annual Reports, CER, Risk Benefit Assessment documents and clinical study
software program selection.
Consultant Medical Writer- Medical Consultant 2014
Reviva Pharmaceutical Company
• Performed medical review and medical writing for CSR and clinical study synopsis for
NDA submission.
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Senior Regulatory and Compliance Consultant 2014
Maetrics-Synthes Clinical Evaluation Report Writer
Provided subject matter expert medical writing, peer reviewed literature search and
clinical summary writing for Synthes orthopedic medical devices. Performed medical
review of CER validation data for EU regulatory body submissions. Developed risk
benefit analysis and post marketing surveillance for data extraction and incorporation
in the CERs.
• Developed Synthes Clinical Evaluation documents in accordance with European
Union guidance MEDDEV 2.7.1, and internal procedures, using relevant information
compiled from clinical research, peer review publications, risk management files, and
post market data.
Performed data extraction from internal risk benefit analysis documents and compliant
documents and summarize findings and write risk versus benefit conclusions based on
based on clinical research, peer review. Identify pertinent internal and external sources
and conduct literature searches of peer review publications in accordance with
European Union guidance MEDDEV 2.7.1. And internal procedures
• Performed medical writing for medical device companies which was need for
development of the documents for medical device labelers which are required to
submit information to the FDA-administered Global Unique Device Identification
Database (GUDID) for regulatory approval.
• Participated in the medical review sessions with medical device companies for
evaluation and interpretation of the rules required for medical device labelers to
include a unique device identifier (UDI) on their medical device labels and packages.
Global Medical Director and Medical Advisor Consultant 2007-Present
Clinical Evaluation Report Writer Medical Review Consultant
Client Advanced Bionics
• Developed Advanced Bionics Clinical Evaluation documents in accordance with
European Union guidance MEDDEV 2.7.1, and internal procedures, using relevant
information compiled from clinical research, peer review publications, risk
management files, and post market data.
Performed data extraction from internal risk benefit analysis documents and compliant
documents and summarize findings and write risk versus benefit conclusions based on
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based on clinical research, peer review. Identify pertinent internal and external sources
and conduct literature searches of peer review publications in accordance with
European Union guidance MEDDEV 2.7.1. and internal procedures.
• Provided subject matter expert medical writing, peer reviewed literature search and
clinical summary writing for Advanced Bionic Cochlear Implant medical devices.
Performed medical review of CER validation data for EU regulatory body
submissions. Developed risk benefit analysis and post marketing surveillance for data
extraction and incorporation in the CERs.
• Provide full CER medical written development for the CER and updated CERs.
• Performed medical writing for medical device companies which was need for
development of the documents for medical device labelers which are required to
submit information to the FDA-administered Global Unique Device Identification
Database (GUDID) for regulatory approval.
• Participated in the medical review sessions with medical device companies for
evaluation and interpretation of the rules required for medical device labelers to
include a unique device identifier (UDI) on their medical device labels and packages.
Senior SciSME (Subject Matter Expert Pharmaceutical 2013-2014
Labeling FDA PDLI-EI Program)
Senior SciSME (Subject Matter Expert) Pharmaceutical Labeling
Provided subject matter expert labeling scientific-medical research for updating
pharmaceutical labeling for FDA projects. Performed label text migration in to the PLR
conversion format for FDA project initiative.
Avodex Partner
Medical Affairs Director Medical Monitor Clinical Studies 2013-2014
Avodex Partners
Medical Monitor
• Consultant medical monitor for clinical trials for Bruin Biometrics to oversee day to
day operation of ongoing clinical trial studies for the medical device. Participated in
protocol development, protocol review, Informed consent development and review.
• Reviewed data listings of safety data, including adverse experiences, laboratory data,
and vital signs data, to establish the presence or absence of abnormal trends, and if
noted, follow up as appropriate with the project team, sponsor, investigator and
FDA. Reviewed coding of adverse events and concomitant medications for accuracy
and consistency. Provided medical writing support for the preparation of clinical
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protocols, protocol addmendments and other documents. Attend and present material
at investigator meetings.
• Provided pharmacovigilance medical surveillance support on Serious Adverse Event
(SAE) reporting for medical device during clinical study activities, follow-ups,
including after hours coverage of medical emergencies.
• Performed medical writing for medical device companies which was need for
development of the documents for medical device labelers which are required to
submit information to the FDA-administered Global Unique Device Identification
Database (GUDID) for regulatory approval.
• Participated in the medical review sessions with medical device companies for
evaluation and interpretation of the rules required for medical device labelers to
include a unique device identifier (UDI) on their medical device labels and packages.
Amgen-Onyx Pharmaceutical December 2012-Present
Senior Medical Writer
• Provided extensive medical writing/medical review for regulatory submission
documents IND, NDA, Safety Narrative, IND,PSURs, CRF, CSR, Protocols, IBs,
PMA, Informed Consents, SOPs BLAs, MAAs, REMS, Amendments Segments
of Annual Reports, CER, Risk Benefit Assessment documents and clinical study
software program selection.
• Senior Medical Consultant for Pharmacovigilance
Novella Clinical October 2013-October 2013
SUBJECT MATTER EXPERT MEDICAL WRITER
Performed medical review and assessment of the clinical study protocol for
orthopedic medical device bone graft material.
Performed medical writing for the clinical study protocol
Participated in medical writing and medical review of the 510(k) submission for
the class II medical device.
Reckitt Benckiser HealthCare May 2012-May 2013
SENIOR MEDICAL WRITER
• Medical writing for CERs, Informed Consents, IB, PSUR, NDA, IND and other
regulatory submission documents for RB.
• Provided clinical study medical support, medical writing, medical review of
clinical/regulatory documents and medical sign-off for phase I, phase II, phase III
and post marketing study phase documents.
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• Responsible for medical review of marketing claims for multiple OTC
therapeutics, KOL identification and advisory board development.
• Clinical trial therapeutic/medical device protocol development and medical
review of protocols.
• Medical Safety narrative writer for clinical studies USA and UK.
• Performed medical writing for medical device companies which was need for
development of the documents for medical device labelers which are required to
submit information to the FDA-administered Global Unique Device Identification
Database (GUDID) for regulatory approval.
• Participated in the medical review session with medical device companies for
evaluation and interpretation of the rules required for medical device labelers to
include a unique device identifier (UDI) on their medical device labels and
packages.
Reckitt Benckiser HealthCare May 2012- May 2013
GLOBAL MEDICAL WRITER
• Provided international clinical study medical support, medical writing, medical
review of clinical/regulatory documents and medical sign-off for phase I, phase II,
phase III and post marketing study phase documents.
• Medical writer for protocols and performed medical design/medical review and
sign-off of orthopedic spine medical device for clinical studies.
• Collected information and documentation on the study to be performed and by
conducting surveys with opinion leaders, experts or potential investigators as
Health Authorities according to Clinical Study Director (CSD) and Feasibility
Manager (FM) (Medical Operations) requirements and timing.
• Provide expert scientific advice and leadership while managing a broad range of
activities associated with the assigned product(s) and therapeutic area (s).
• Responsible for local scientific knowledge and lobbying allowing capture of
country specific information on competitive intelligence and validation of global
hypothesis from the Clinical Development Plan or assessment of Extended
Synopsis (ES)/ protocol contents.
• Ensured all activities under his/her direction comply with Clinical Development
Standard Operating Procedures (SOP’s), Good Clinical Practices and US, EU and
Canadian Regulations.
• Medical Safety narrative writer for clinical studies USA and UK.
• Participated in 510(k) submission document preparation for Scholls medical
devices.
Combat Casualty Care Research Program Medical Surgical Consulting, Virginia
/Montana
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MEDICAL DIRECTOR
2011-2012 Developed and performed medical writing for multiple aspects of clinical
studies (pre-clinical and Phase I-IV).
• Provided extensive medical writing/medical review for regulatory submission
documents IND, NDA, Protocols, Informed Consents, SOPs and clinical study
software program selection.
• Medical Safety narrative writer for clinical studies USA clinical studies.
• Performed clinical study document medical writing and 505(b) (2) literature
submission document preparation and medical review.
Advanced Bionics, California
PRINCIPLE EXPERT CLINICAL EVALUATION REPORT MEDICAL WRITER
2010-2013
Medical Consultant
• Clinical evaluation expert report writer for Cochlear Implant medical devices for
submission to the TUV.
• Provided detailed review and evaluation of associated safety data was performed
utilizing certain prescribed or recommended guidelines, including guidance
documents developed by the International Organization for Standardization (ISO) and
FDA.
• Performed medical writing for medical device companies which was need for
development of the documents for medical device labelers which are required to
submit information to the FDA-administered Global Unique Device Identification
Database (GUDID) for regulatory approval.
• Participated in the medical review session with medical device companies for
evaluation and interpretation of the rules required for medical device labelers to
include a unique device identifier (UDI) on their medical device labels and packages.
Department Of Defense / KForce Government Solutions January 2009- January 2011
MEDICAL WRITER / FDA CONSULTANT
• FDA Lead Medical Consultant for establishment of FDA guidance document for
clinical trials.
• Developed extensive regulatory guidance submission processes/document for
bioterrorism immunoassay medical device.
• Reviewed documentation for Immunoassay/Biodefense efficacy.
• Served as the technical FDA expert and represented the department as the FDA
expert Medical Writer.
• Reviewed and created Clinical Study Protocols, Informed Consent Forms,
Clinical Study Reports, patient narratives and regulatory submission documents in
accordance with FDA, GCP and ICH guidelines and applicable regulations.
• Responsible for the independent preparation of clinical study reports, integrated
clinical summaries, overviews, and other regulatory documents for an
investigational device that is going into Phase III clinical trial activity and is
currently in various stages of clinical development.
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Indegene Pharmaceutical Solutions July 2008- July 2009
MEDICAL CONSULTANT
• Consulting activities to included developing the pharmaceutical and biotech client
base for Competitive & Scientific Intelligence and Medical Education services
and products on a part-time basis.
• Medical Safety narrative writer for clinical studies USA oncology studies.
BRAHMS-USA
Assistant Director for Medical Education BRAHMS-USA 2008- 2009
Maryland/Berlin Germany
• Medical Monitoring, Medical device company review committee consultant
/Assistant Director for Medical Education with international/global interaction/
travel. Reviewed therapeutic data for sepsis biomarker, immunology, MRproANP
and PCT Developed medical education curriculum for Sepsis biomarkers,
Cardiac Biomarkers.
• Developed and maintained professional relationships with Key Opinion Leaders
(KOL's) and academic centers in therapeutic areas of commercial and research
interests. Provided appropriate scientific and technical support. Developed
speakers resources through one-on-one clinical training on approved clinical slide
sets.
SciMedica
SciMedica Medical Education Company, LLC. : 2005-2010
• Medical Liaison for CME development projects: ADHD, Schizophrenia,
Colorectal, Ophthalmology, Cancer (Roche), Breast Cancer (Roche), Ovarian
Cancer (Shire), ITP, Ulcerative Colitis Respiratory Dysfunction, Asthma.
• Medical Consultant for CME development projects and Senior Medical
Moderator for CME projects and KOL presentations and senior medical
moderator for CME projects and KOL presentations conducted with selected
KOL’s
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Hedis January 2007- January 2008
MEDICAL CONSULTANT
• Performed medical chart review for inpatient/outpatient projects
• Performed independent case medical chart review, medical data extraction, ICD-9
coding review, CPT coding review, medical consent form review, peer review of
medical provider data, and scientific review of charts involved in clinical trials.
Bristol-Myers-Squibb Pharmaceutical Company January 2006- March 2007
MEDICAL WRITER
• Medical Writer for multiple therapeutic study protocols
• Wrote, researched, and edited clinical reports, summarizing data from clinical
studies for submissions to the FDA and for publication and/or presentation.
• Independently wrote and edited projects for the medical and scientific
communities (i.e., manuscripts for publication in peer-review journals, abstracts,
posters and review articles).
• Interpreted data from study reports, medical and scientific publications, and
generate graphs and tables.
• Participated in the preparation of Clinical Study Reports (CSRs), Investigator's
Brochures and integrated summaries.
• Responsible the development and review/revision of protocols and clinical study
reports (CSRs) for preclinical and clinical studies.
• Participated in the development of IB's, components of IND, sections of NDA
submissions, regulatory responses, and other clinical/regulatory documents.
• Significant experience writing SOP has and is familiar with ICH and GCP
guidelines.
• Experience with the preparation of common technical document such as IND,
NDA, ISS, ISE, protocol and Informed Consent development.
• Therapeutic area included CNS, oncology, cardiovascular, infectious disease,
virology, metabolic, endocrine and core protocol therapeutic for women’s
healthcare.
• Medical safety narrative writer for clinical studies USA oncology studies and
vascular studies.
PRIVATE PRACTIVE and STAFF PODIATRIST 1992 - 2006
Locations across Louisiana (list available upon request)
• Served 7 nursing homes, 3 health care centers, and 2 hospital / rehabilitation centers
• Created, established and maintained the Podiatry sections at 4 correctional center
facilities in New Orleans, LA.
• 80% of the private clinical/ surgical practice involves patients with diabetic
neurotrophic wounds with associated circulatory and cardiac dysfunction
EDUCATION:
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Doctor of Podiatric Medicine (DPM)
Ohio College of Podiatric Medicine, Cleveland, OH
BS in Zoology; Minor in Chemistry
Howard University, Washington, DC
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