image5

Get to Know Me- Dr. Turner SME Global Medical Advisor

Dr. Turner Provides Medical Device and Pharmaceutical Industry Experience You Can Count On

Dr. Turner's service includes a comprehensive consultation to help identify MDR gaps and  opportunities for the medical device and pharmaceutical industry,  provide a comprehensive report that includes a project plan with  timelines and milestones, a cost analysis, and a schedule. Dr. Turner will also offer  a suite of  Notified Body compliant technical file document submission templates  to include the following:

 

CEP

Literature Search Term algorithms (You will need 3-4 search term algorithms patterns for BSI and TUVSUD compliance

Literature search Protocol document

Literature Review Protocol Document

Literature Review Plan Document 

Literature Review Report Document

PMS Plan Document

PMS Report Document

PMCF Plan Document

PMCF Report Document

PMCF Study Plan Document

PMCF Study Report Document (This now critical as the notified body will not renew a certificate unless you show the methodology for a clinical study for MDR compliance)

SSCP Plan

SSCP Report

UDAMED document data


My Notified Body experience as a former Notified Body Clinician Clinical Evaluation Specialist Reviewer at both BSI and TUVSUD has been infused  into my development of quality Notified Body compliant technical file template submission document products that will help you navigate  Notified Body compliance to get your group there quickly and  smoothly. That’s how Dr. Turner ensures your success.


 Dr. Turner's goal is to utilize his 28 years of experience and expertise to you needs by applying his  extensive experience as a medical director military clinical trial coordinator director, medical director for clinical research organizations (CRO), clinical trial feasibility assessment, implementation-clinical documentation improvement physician trainer-physician advisor, medical monitor for multiple clinical studies, project management, assistant medical director and senior global medical adviser for medical affairs departments which I have gained from my training and working for several biotechnology, pharmaceutical and medical device companies in which my projects specifically involved therapeutic agents to include oncology, ophthalmology, dermatology, upper respiratory, dermatology, orthopedics-rheumatology /orthopedic trauma, vascular, wound healing, cardiology, neurology and gastrointestinal pharmaceutical therapeutic agents-medical devices. I am strategically located on the U.S. eastern seaboard near a major airport as this has played a key role in my successful medical affairs activities which can be applied to your organization.


In addition, Dr. Turner  has conducted  national presentations for organizations to include (RAPS), has lectured globally in Brussels, Paris, London, Belgium, Austria, Germany,Ireland and in mutiple states within the USA. Dr. Turner is available for your national or international presentation needs. 


Mission Statements – Dr. Turner has had the pleasure of providing SME Medical Device and  Pharmaceutical industry Medical Advising services to multiple companies. Dr. Turner's goal is to provide exceptional medical advisory services to your organization which have been gained over the years (28).

    

As a medical director and assistance medical affairs director, I have had the pleasure of performing medical-clinical advising and medical writing for several pharmaceutical-biotechnology companies working specifically on several oncology projects that have impacted what is most important to me which is improving the well-being of patients. Specifically, 


Dr. Turner has worked with ophthalmology, orthopedic, respiratory, dermatology, vascular, wound healing, cardiology, infectious diseases, neurology and oncology advisory boards selected by pharmaceutical companies, biotechnology companies and the 

US Military.


Dr. Turner has worked on development of advisory boards and KOL selection for these types of organizations. 

  

Dr. Turner has been the Medical Clinical Evaluation Specialist for Orthopedic, Cardiovascular, AIMD, IVDR and Oncology medical devices for Class I, Class IIa, Class IIb and Class III medical devices for the notified bodies TUVSUD, BSI and organization such as RAPS. In addition, I have performed subject matter CER curriculum development for transition from MDD to MDR.

Dr. Turner is a medical lecturer for the transition from MDD to MDR for medical device organization(s) and medical device manufacturers with a focus on State of the Art, Clinical Study Investigations, Post Market Surveillance (PMS), Post Market Clinical Follow-up, Post Market Clinical Follow-up Studies, Summary of Safety and Clinical Performance (SSCP) and Equivalence. In addition, I perform gap analysis reviews of CER(s) for Class I, Class IIa, Class IIb AND Class III medical devices for manufacturers.

In addition, Dr. Turner has worked with medical education companies associated with Shire Pharmaceutical Company for CME/CE KOL programs for the management of ulcerative colitis. This program was performed in conjunction with the John Hopkins University School of Medicine with the API Mesalamine, Balsalazide, Sulfasalazine and Immunomodulators. Specific are of concentration for this project was focused on the use of ACG guidelines for treating mild to moderate ulcerative colitis.

Dr. Turner has traveled to all fifty states and functioned as the medical moderator, medical compliance officer and medical writer with the selected oncology KOL team selected by Roche and OrthoBiotech. These presentation included attending departmental briefing meetings within over 300 hospitals, conducting over 1000 teleconferences/webinar seminar with these selected KOL’s which included dinner meetings. 

As a medical director, assistant medical director for medical affairs, I have managed the complexities of this position with both large and small pharmaceutical companies and biotechnology companies. During my medical affairs position work, I hired, mentored and developed team members to work with me as I developed strategies for global marketing, global clinical studies (pre-clinical thru phase IV, post marketing studies) regulatory document compliance review, promotional material review, global launches legal review, consumer care, R&D drug delivery system review/ literature research, clinical study protocol review, informed consent review, establishing field based MSL teams, field based clinical liaison teams, developed field based medical literature/PowerPoint presentations for field based use of FDA approved products along with different stages of clinical trial activity presentations and evidence based medical communication delivery strategy plans.

Dr. Turner has provided extensive medical writing/medical review for pharmaceutical and biotechnology company’s clinical/regulatory documents with medical sign-off for both U.S. and EU sector for multiple therapeutic areas for client’s medical affairs departments. 

Within the medical affairs department of several pharmaceutical-biotechnology companies I have performed medical affairs activities to include: medical safety review, pharmacovigilance safety data review (therapeutic agents/medical devices) for multiple clinical trials where I have written in excess of 8,000 safety narratives covering multiple therapeutic areas for different projects for both U.S. and EU clinical studies. In addition, 


I have provided pharmacovigilance for these therapeutic agents and safety reviews for medical devices for orthopedic spine devices.


I have authored CER For the following companies,Advanced Bionics, BARD,  WIPOR,Wound Solutions, Scholls, Synthes, ETHICON,Valiant Pharmaceutical, Somahlution. St. Jude Medical-Abbott and NAMSA.


AREAS OF CLINICAL PARTICIPATION HISTORY AND CURRENT INTEREST INCLUDE

· Diabetes and Diabetic Wounds

· Podiatric Dermatology

· Dermatology

· Regenerative Medicine

· Gastroenterology

· Circulatory Dysfunction

· Ophthalmology 

· HIV-Dermatological Manifestations/Lower Extremity Complications

· Virology and Bacteriology

· Osteopathic / Orthopedic Dysfunction 

· Rheumatology

· Radiology

· Lower extremity Oncology - Bone /Soft-Tissue Malignancy

· Pharmacology

· Pharmacovigilance Monitoring/Reporting

· Lower Extremity Reconstructive Surgery Foot/Ankle

· Lower Extremity Venous/Arterial Wounds

· Lower Extremity Diabetic Wounds

· Wound Care Therapeutics 

· Infectious Disease

· Respiratory Dysfunction/Asthma

· Adverse Event Reporting/Monitoring

· Allergy Reactions

· Drug Safety Risk Management Analysis of Post Marketed Therapeutic Medications.

Dr. Turner's Summary of Clinical Research skills and participation include;

  

DoD) Department Of Defense –Medical Chart Reviewer (Public Trust Clearance Classified)

(DoD) Department Of Defense Senor FDA Consultant Analyst/Medical Writer 

DDMAC Reviewer

Clinical Reviewer Notified Body for CER and Technical File Data

Subject Matter Expert for performance of CER Gap Analysis 

Senior Global Medical Adviser

Critical Analysis Clinical Expert Report Developer

Clinical Trial Data Extraction Manager

Scientific Review Officer, Scientific Review Manager, Project Manager

Scientific Review Administrator

Clinical Medical Monitor/GCP Auditor    

Assistant Director for Medical Educations

Podiatric Medical Director

Medical Moderator

Associate Podiatric Medical Director

Medical Information Specialist

Medical Science Liaison

Medical Advisor / Medical Liaison

Medical Writer/ Technical Writer

Pharmaceutical review committee participant

Medical Device review committee participant 

Pharmacovigilance Monitor

Project Manager

Medical Lecturer

Adverse Event Monitor / Reporter

Medical Case Reviewer

Clinical Research Associate/GCP Auditor

Medical Content Developer / Editor

Safety Reviewer/ Safety Associate

Medical Training Consultant

Data Reviewer

Medical Chart Reviewer

Medical Education Seminar Developer

Medical Education Program Developer

Pharmaceutical Educational/CME Seminar Content Developer/Presenter Consultant

Assistant Medical Director for Sepsis and Cardiovascular Biomarkers Medical Education Programs United States/ Germany

Oncology Biomarkers

Senior Analyst Expert FDA

Laboratory research assistant National Institutes of Health Laboratory of Infectious  Diseases and Laboratory of Immnunogenetics


Dr. Turner is available for these services for your organization.


Company policies – To provide exceptional Global Medical Advisor services to your organization. Please contact Dr. Turner at (540 316-8030 or write to Dr. Turner at  neuroma7@msn.com.


Executive profiles – A company is only as strong as its executive leadership. Dr. Turner has provide leadership in the following capacities:

  

(DoD) Department Of Defense –Medical Chart Reviewer (Public Trust Clearance Classified)

(DoD) Department Of Defense Senor FDA Consultant Analyst/Medical Writer 

DDMAC Reviewer

Clinical Reviewer Notified Body for CER and Technical File Data

Subject Matter Expert for performance of CER Gap Analysis 

Senior Global Medical Adviser

Critical Analysis Clinical Expert Report Developer

Clinical Trial Data Extraction Manager

Scientific Review Officer, Scientific Review Manager, Project Manager

Scientific Review Administrator

Clinical Medical Monitor/GCP Auditor    

Assistant Director for Medical Educations

Podiatric Medical Director

Medical Moderator

Associate Podiatric Medical Director

Medical Information Specialist

Medical Science Liaison

Medical Advisor / Medical Liaison

Medical Writer/ Technical Writer

Pharmaceutical review committee participant

Medical Device review committee participant 

Pharmacovigilance Monitor

Project Manager

Medical Lecturer

Adverse Event Monitor / Reporter

Medical Case Reviewer

Clinical Research Associate/GCP Auditor

Medical Content Developer / Editor

Safety Reviewer/ Safety Associate

Medical Training Consultant

Data Reviewer

Medical Chart Reviewer

Medical Education Seminar Developer

Medical Education Program Developer

Pharmaceutical Educational/CME Seminar Content Developer/Presenter Consultant

Assistant Medical Director for Sepsis and Cardiovascular Biomarkers Medical Education Programs United States/ Germany

Oncology Biomarkers

Senior Analyst Expert FDA

Laboratory research assistant National Institutes of Health Laboratory of Infectious  Diseases and Laboratory of Immnunogenetics


Dr. Turner's services will include  a comprehensive consultation to help identify gaps and opportunities, a comprehensive report that includes a project plan with  timelines and milestones, a cost analysis, and a schedule. We also offer  a suite of quality Notified Body compliant technical file submission template documents products that Dr. Turner has taken his due diligence to develop from his experiences as a  former Notified Body Clinician Clinical Evaluation Specialist Reviewer with both Notified Bodies BSI and TUVSUD. Dr. Turner will help navigate the complexity of technical file document submission to Notified Bodies  to help get you there quickly and  smoothly. That’s how we ensure your success.

Learn More

Our ramp up process is designed  to empower your team and outfit them with the tools they need to  succeed. Talk to us today about how we can support your growth, limit   delays in technical file submission,reduce the receipt of deficiency reports from your contracted Notified Body  and increase acceptance of technical file documents submitted to your contracted Notified Body  and submission of your documents to the FDA. to put you on a solid track to success and regulatory compliance.

Our Partners

image6
image7
image8
image9