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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