- Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to CRG's corporate policies and SOPs/WPDs.
- Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
- Provides therapeutic training and protocol training on assigned studies, as
- requested.
- Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
- Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
- Discusses all medical concerns with principal investigators and clients (eg discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
- Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
- Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
- Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
- Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
- MD or equivalent required. Active medical licensure preferred.
- Candidates should have at least one of the following:
- Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training (comparable to 2 years). ie: Neurologist
- Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry.
- Direct experience in safety/Pharmacovigilance (comparable to 2 years).
- Candidates with industry experience(CRO/Pharma) maybe considered for Medical Director/Senior Medical Director level.
- Therapeutic expertise across one or more medical specialty or sub-specialties
- Strong decision-making, problem solving, organizational skills and analytical skills
- Excellent oral and written communication skills
- Working knowledge of relevant safety databases (eg Medra)
- Flexibility to travel domestically and internationally
- Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
- Proficiency in basic computer applications
- Fluent in spoken and written English
- Excellent interpersonal, influencing and team building skills
- Understanding guidelines (FDA, ICH, EMA and GCP)
- Working knowledge of biostatistics, data management, and clinical operations procedures
- Ability to act as a mentor/trainer to other staff within PV
-
Medical Director
4 weeks ago
STAFF ICONS, LLC Greenville, United StatesWe are seeking a pathologist to act as a Medical Director · CALL OR TEXT KATHY @ · Qualifications · MD or DO degree plus accredited pathology residency · Must be board certified in anatomic and clinical pathology · 3+ years post residency experience desired · Ability to spend ...
-
Medical Director
5 days ago
Favorite Healthcare Staffing Greenville, United StatesJob Description · Job DescriptionA recovery center in Greenville, SC is currently seeking to add a Medical Director to join their team full-timeCheck out the details below: · Title: Medical Director · Job Type: Permanent / Direct Hire · Setting: Rehabilitation · Location: Green ...
-
Medical Director
2 weeks ago
National Veterinary Associates Greenville, United StatesJob Description · Upstate Vet Emergency + Specialty Care in Greenville, SC is seeking a Medical Director to join their growing team · We currently offer Dentistry, Cardiology, Internal Medicine, Oncology, Ophthalmology, Neurology, Emergency and Critical Care, and Surgery. We have ...
-
Medical Director
3 weeks ago
Favorite Healthcare Staffing Greenville, United StatesJob Description · Job DescriptionA recovery center in Greenville, SC is currently seeking to add a Medical Director to join their team full-timeCheck out the details below: · Title: Medical Director · Job Type: Permanent / Direct Hire · Setting: Rehabilitation · Location: Green ...
-
Medical Director
2 weeks ago
AID Upstate Greenville, United StatesJob Type Full-timeDescriptionSEEKINGWe are looking for someone to provide direction for and monitoring of healthcare delivery services offered by our organization within the context of a team setting while acting as a responsible leader, expert practitioner, educator/teacher, con ...
-
Medical Director
3 weeks ago
National Veterinary Associates Greenville, United StatesJob Description · Upstate Vet Emergency + Specialty Care in Greenville, SC is seeking a Medical Director to join their growing team · We currently offer Dentistry, Cardiology, Internal Medicine, Oncology, Ophthalmology, Neurology, Emergency and Critical Care, and Surgery. We have ...
-
Regional Medical Director
1 day ago
State of South Carolina Greenville, United StatesSalary: $154, $168,913.00 Annually · Location : Greenville County, SC · Job Type: FTE - Full-Time · Job Number: /165476 · Agency: DHEC-PH-Region-Upstate · Opening Date: 06/04/2024 · Closing Date: 6/13/2024 11:59 PM Eastern · Class Code:: UB27 · Position Number:: /165476 ...
-
Medical Director
3 weeks ago
Staff Icons Greenville, United StatesGI/LIVER PATHOLOGIST IN BEAUTIFUL GREENVILLE, SOUTH CAROLINA · VERY, VERY COMPETITIVE SALARY INQUIRE WITHIN · CALL OR TEXT KATHY @ · Position Summary · : · The Pathologist, with expertise and/or fellowship training in · Gastrointestinal Pathology , will analyze and understan ...
-
Director of Finance
1 week ago
Infinity Systems Greenville, United StatesYour new employer · Our client is a rapidly growing technology company based in Nuremberg with a global influence. As a hidden champion, the company is a leader in the development and provision of innovative coating solutions and impregnations in various application areas, parti ...
-
Medical Director Center For telepsychiatry
2 weeks ago
East Carolina University Greenville, United StatesJob Title MEDICAL DIRECTOR CENTER FOR TELEPSYCHIATRY & E-BEHAVIORAL HEALTH Position Number Vacancy Open to All Candidates Department EHH BSOM Psychiatry and Behav Med Department Homepage Advertising Department PSYCHIATRIC MEDICINE - ADMIN Division ECU Health/BSOM Classification ...
-
Remote Director, Medical Review
3 weeks ago
HealthPRO Heritage Greenville, United StatesOverview · The Director, Medical Review will: · Lead tracking and coordination of all direct bill therapy appeals, ensuring thorough data compilation and analysis. Lead ALJ hearing preparation and maintain professional communication with facility and corporate personnel. Communic ...
-
Clinical Medical Director MD/DO
3 weeks ago
Valor Healthcare Greenville, United States Full timePosition Summary · The Clinic Medical Director (CMD) is responsible for all clinical aspects of their individual CBOC. The physician diagnoses and treats diseases and injuries of human internal organ systems and delivers preventive treatment of primary care needs, including chron ...
-
Physician - Medical Director Primary Care
3 weeks ago
Veterans Health Administration Greenville, United StatesSummary · This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in accordance with VHA policy and submit your EDRP application within four months of app ...
-
Thermofisher Scientific Greenville, United StatesJob Description · We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, part of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You ...
-
Director of Medical Policy
4 days ago
Fluor Greenville, SC, United StatesDiversity StatementAt Fluor, we are proud to design and build projects and careers. This requires teams that are as unique as the projects we execute. We are committed to fostering a work environment that embraces Diversity, Equity, and Inclusion (DE&I) for all so our employees a ...
-
Assistant Director
4 weeks ago
KinderCare Education Greenville, United States Full timeAssistant Director LR) Description Futures start here. Where first steps, new friendships, and confident learners are born. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer ...
-
Maintenance Director
6 days ago
Navion Senior Living Greenville, United States Full timeNavion of Greenville, a community of Navion Senior Solutions located in Greenville, NC, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and oth ...
-
Music Director
2 weeks ago
InsideHigherEd Greenville, United StatesJob Title:Music Director /Accompanist/ Performing Artist · Position Number :500246 · Vacancy Open to :All Candidates · Department :AAH School of Theatre and Dance · Department Homepage :Advertising Department :THEATRE&DANCE,SCH OF · Division :Academic Affairs · Classification Ti ...
-
Director of Operations
2 weeks ago
InsideHigherEd Greenville, United States Administrative Jobs ,Job Title:Director of Operations - Women's Lacrosse · Position Number :500263 · Vacancy Open to :All Candidates · Department :ATH Womens Lacrosse · Department Homepage :Advertising Department :LACROSSE - WOMEN · Division :Athletics · Classification Title :Director-Professional ( ...
-
Director of Medical Staff, Greenville Market
3 days ago
Bon Secours Health Greenville, United StatesThe Medical Staff Office (MSO) supports the medical staff organization activities including credentialing, privileging, quality improvement activities and medical staff organization governance. The Director promotes close, effective working relations Staff, Director, Medical, Med ...
Associate Medical Director/Medical Director - Greenville, United States - Thermofisher Scientific
Description
Job Description
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, part of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( eg PBRER, PSUR, DSUR) as well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
Essential Functions:
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
General Support:
Clinical Trial Support:
Marketed Products Support:
Qualifications, Education and Experience:
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Associate Medical Director/Medical Director professionals in Greenville
-
Wyatt Powell
Salesforce implementation and administration