Medical Director

hace 2 semanas

Santiago de Chile Thermo Fisher Scientific A tiempo completo

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

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 ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. 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:

- Ensures tasks delegated to PVG 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 PPD’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.
- Contributes to departmental process improvement initiatives.

Clinical Trial Support:

- 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 (e.g. 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.

Marketed Products Support:

- Manages signal detection activities, generates 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.

**Qualifications**:
Education and Experience:

- Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training(comparable to 2+ years) and one of the following:

- Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or
- Direct experience in safety/Pharmacovigilance (comparable to 2 years).
- 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**:

- 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 (e.g. Medra)
- Flexibility to travel domestically and internationally
- Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
- 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 PVG

**Working Conditions and Environment**:

- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels both domestic and international.

**Physical Requirements**:

- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Moderate mobility required.
- Occasional crouching, stoopi

  • Neuroscience Medical Director

    hace 3 días

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    Key Responsibilities:Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.Provide medical consultation to team members and answer study-related medical questions.Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.The Neuroscience...

  • Medical Director

    hace 4 semanas

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    Press continue to see content specific to your location. Medical Director - Neurosciences (Remote LATAM) Santiago Remote CLP 20,000,000 - 40,000,000 Join to apply for the Medical Director - Neurosciences (Remote LATAM) role at Thermo Fisher Scientific . Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Provides medical...

  • Medical Director Position

    hace 5 días

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    Job Summary:As a Senior Medical Director at Thermo Fisher Scientific, you will oversee the medical aspects of clinical trials across various pharmaceutical product life-cycles. Your responsibilities will include managing signal detection activities, generating aggregate reports, contributing to label updates, and supporting risk management activities. You...

  • Senior Medical Director

    hace 4 días

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    Job Description:The Senior Medical Director - Neurosciences Specialist will provide medical oversight of clinical trials to ensure that all company Standard Operating Procedures (SOPs), client directives, good clinical practice, and regulatory requirements are followed.The ideal candidate will have a strong background in neurology or psychiatry and...

  • Medical Director of Clinical Trials and Safety

    hace 3 días

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    About the Role:The Medical Director of Clinical Trials and Safety will be responsible for providing medical review and analysis for clinical trial serious adverse events, marketed products ICSR, and periodic safety reports.This role requires a strong understanding of regulatory requirements and industry standards, as well as excellent analytical and...

  • Medical Science Liaison Chile

    hace 2 horas

    Santiago de Chile BioMarin Pharmaceutical Inc. A tiempo completo

    BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...

  • ICU Medical Director

    hace 4 días

    Santiago, Metropolitana, Chile NHS National Services Scotland A tiempo completo

    Join our team at Victoria Hospital as an intensive care medicine consultant and contribute to delivering excellent patient care and driving service improvement. You will work alongside a department of 9 ICM consultants and be responsible for leading our ICU team.You will have the opportunity to develop your skills and interests in a supportive environment....

  • IT Director of Enterprise Applications

    hace 3 semanas

    Santiago de Chile Woodgrain A tiempo completo

    **Full-Time, Exempt** **_ *Relocation Assistance may be available*_** - Woodgrain Inc. offers competitive salaries, annual incentive bonuses, and great benefits. Current benefits include: 401(k) with employer match (3%), Medical, Dental, Vision, Life Insurance, Employer paid Short - and Long-Term Disability, voluntary supplemental coverage plans, 8 annual...

  • Associate Director, Latin America Healthcare

    hace 2 semanas

    Santiago de Chile bioMérieux sa A tiempo completo

    **Director Healthcare Information Solutions & Services, Latin America** **Primary Purpose and Overall Objective of the Job**: By working with bioMérieux IT VISION Suite, laboratory, hospital and healthcare systems engage in strategic projects to enhance diagnostic & clinical decisions. As **DIRECTOR HEALTHCARE INFORMATION SOLUTIONS & SERVICES **You will...

  • Deputy Director for Operations

    hace 2 semanas

    Santiago de Chile Associated Universities, Inc. A tiempo completo

    **_ALMA Vacancy Notice_** **_ Deputy Director_** **_ for_** **_ Operations_** The Atacama Large Millimeter/submillimeter Array (ALMA) is a millimeter/submillimeter interferometer consisting of 66 antennas located at 5000 m altitude on the Llano de Chajnantor in the Atacama Desert of northern Chile. It is equipped with receivers covering the atmospheric...

  • Deputy Director for Development

    hace 2 semanas

    Santiago de Chile Associated Universities, Inc. A tiempo completo

    **_ALMA Vacancy Notice_** **_ Deputy_** **_ Director_** **_ for_** **_ _** **_Development_** The Atacama Large Millimeter/submillimeter Array (ALMA) is a millimeter/submillimeter interferometer consisting of 66 antennas located at 5000 m altitude on the Llano de Chajnantor in the Atacama Desert of northern Chile. It is equipped with receivers covering the...

  • Regional Commercial Director

    hace 2 días

    Santiago, Metropolitana, Chile FLSmidth A tiempo completo

    Commercial LeadershipWe are looking for an experienced Regional Commercial Director to join our team at FLSmidth. As a key leader in our commercial function, you will be responsible for driving business growth in the mining industry, developing and executing a sales strategy that aligns with our company's MissionZero programme.About the RoleDesign and...

  • Health Care Compliance Director

    hace 3 semanas

    Santiago de Chile Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...

  • Neurosciences Clinical Trials Lead

    hace 5 días

    Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo

    About the Job:Thermo Fisher Scientific is seeking an experienced Senior Medical Director to lead our neurosciences clinical trials team. As a key member of our research and science department, you will be responsible for providing medical oversight of clinical trials and ensuring company SOPs, client directives, good clinical practice, and regulatory...

  • Business Unit Director

    hace 2 semanas

    Santiago de Chile MSD A tiempo completo

    This is an exciting opportunity to join our Chilean team, a pioneer subsidiary. Here we take an ecosystem approach to the business. We are driven by data, insights, and digital transformation to create and capture customer value by radically improving the customer experience. We are a fast, agile, and most of all, resilient organization. We believe what...

  • Business Unit Director

    hace 2 semanas

    Santiago de Chile Merck Sharp & Dohme A tiempo completo

    Job Description This is an exciting opportunity to join our Chilean team, a pioneer subsidiary. Here we take an ecosystem approach to the business. We are driven by data, insights, and digital transformation to create and capture customer value by radically improving the customer experience. We are a fast, agile, and most of all, resilient organization. We...

  • Director, Sales

    hace 2 semanas

    Santiago, Metropolitana, Chile Equinix A tiempo completo

    Who are we?Equinix is the world's digital infrastructure company, operating over 260 data centers across the globe. Digital leaders harness Equinix's trusted platform to bring together and interconnect foundational infrastructure at software speed. Equinix enables organizations to access all the right places, partners, and possibilities to scale with...

  • Msl Oncology

    hace 3 semanas

    Santiago de Chile MSD A tiempo completo

    **Job Description**: Under the general supervision of the MSL Manager, the Medical Science Liaison serves as an advocate for MSD science within the healthcare community. By virtue of his/her training, the MSL is well-positioned to discuss and provide scientific and therapeutic information to Health Care Professionals and Researchers (Clinical and Scientific...

  • Senior Director, Corporate Affairs, Latam Area

    hace 2 semanas

    Santiago de Chile AstraZeneca A tiempo completo

    **Senior Director, Corporate Affairs, LatAm Area*** Location: LatAm (all regions considered) Competitive salary and benefits package The Senior Director, Corporate Affairs, LatAm will lead the development and delivery of an integrated corporate affairs plan to drive key regional business objectives and enhance global, regional, and local alignment. As...

  • Outbound Transportation Director

    hace 12 horas

    Santiago, Metropolitana, Chile Stryker Group A tiempo completo

    What You'll DoThis challenging role requires strong leadership skills, analytical thinking, and attention to detail to drive sustainability initiatives and improve logistics processes.Drive sustainability initiatives by implementing eco-friendly packaging solutions, optimizing transport routes to reduce emissions, and ensuring responsible resource...