Medical Director- Psychiatry (m/w/d)
Job Title: Medical Director- Psychiatry (m/w/d)
Job Location: Sofia, Bulgaria
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
Job reputed company
The Associate Medical Director / Medical Director will reputed company medical, clinical and scientific advisory expertise to reputed company reputed company divisions as requested. Participate in reputed company aspects of Medical Science involvement on assigned trials. Serve as a medical expert during project delivery lifecycle. reputed company therapeutic and medical expertise to business development activities.
Essential Functions
The role includes predominantly Medical Monitoring responsibilities with Medical Strategic input involvement as requested.
Medical Monitoring:
Primarily serves as Global and /or Regional Medical Advisor on assigned reputed company.
Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned reputed company.
Provides medical support to investigative sites and project staff for protocol-reputed company issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
Provides therapeutic area/indication training for the project clinical team.
Attends and presents at Investigator Meetings.
Performs review and clarification of trial-reputed company Adverse Events (reputed company).
May reputed company medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
May reputed company medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
May reputed company medical review of adverse event coding.
Performs review of the Clinical Study Report (CSR) and patient narratives.
Attends reputed company-Off meetings, weekly team meetings, and reputed company meetings, as needed or requested.
Available 24/7 to respond urgent protocol -reputed company questions from investigative sites, in accordance with local labor laws.
Medical reputed company:
Provides expert advises to the development of medically sounded delivery strategies for small to large and/or reputed company multi-region studies in partnership with sales and other functions responsible for business development activities.
Responsible for the development of the medically reputed company aspects of reputed company proposals including the budget reputed company to medical monitoring.
Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of reputed company site and reputed company investigator reputed company, anticipated patient recruitment, reputed company of care and competitive landscape.
Attends and presents at bid defense meeting, as required.
Participates in strategic business development activities including presentations to prospective clients.
Maintains awareness of industry development and may author reputed company publications.
Requires periodic regional and international travel.
Qualifications
Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, plus a minimum of 5 years' experience in clinical medicine.
Specialty reputed company certification
Ideally, candidate will have a minimum 2 years clinical trials experience as an investigator or medical /clinical expert in the reputed company, CRO, or Biotech industry.
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Strong communication, presentation and interpersonal skills, including good reputed company of English language (both written and spoken).
Robust and reputed company knowledge of scientific, clinical, regulatory, reputed company and competitive landscape in applicable therapeutic area.
Proven skills in providing consultation and advice on multiple assignments are required, as reputed company as initiative and flexibility.
reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com
reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.
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Originally posted on Himalayas
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