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Job Title: Medical Writer V
- This role is key to help the medical supervision of clinical studies by Clinical Study Directors and to ensure scientific management of clinical studies to be performed by the Clinical & Sciences Operations Platform
- The primary purpose of the Clinical Scientist's (CSc) position is to assist/support the Clinical Study Director (CSD) in the medical/scientific contribution for the clinical studies: e.g: contributing/reviewing of extended synopsis, protocols, amendments, amended protocols, support to medical review of study data (especially safety data with reconciliation), review of draft study reports or draft publications for accuracy, search of medical/scientific information for study teams, literature review and analysis, assists in the preparation of the responses for investigators, study teams, ethics committees or regulatory authorities, helps manage study committees.
- Scope include all clinical trials for projects in development (excluding Phase I in healthy subjects, Phase I Onco and POC managed by CEP) and clinical studies (e.g. registries) for marketed drugs or devices, from scientific assessment of a clinical project to final deliverable (clinical study report, clinical part of a CTD)
- Under the guidance of the CSD and/or medical operations management : he/she collaborates with the Coding specialist, Biostatisticians, CTOMs, R-TMs, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. review of narratives) on high quality medical review, as needed.
- He/she supports the Leader, Transversal Functions and functionally to the CSD to ensure appropriate documentation and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
- KEY INDIVIDUAL ACCOUNTABILITIES
- Ensure scientific and operational support for execution of activities within the CSO for study(ies) he/she is allocated to, under the functional supervision of the CSD and/or Medical Operations management.
- Is involved in the quality and update of study documents, CRF agreement with protocols/protocol amendments and will help in the objective of decreasing protocol complexity.
- For all new protocols, is in charge of assessing the protocol complexity, before and after protocol review, and after any protocol amendment.
- Is involved in medical reviews of study data under the CSD supervision, supporting the CSD for the Medical Review cases and for review of safety events reported to GPE.
- Support CSD for the preparation, organization and minutes of Study Committee meetings to include Steering Committee and Data Monitoring Committee
- Prepare the contracts for Study Committees in collaboration with business support.
- Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (extended synopsis, protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form...). Participate in CTT and monitoring team training on medical information.
- Provide or prepare medical or scientific information/documentation/analysis when appropriate for protocol preparation or study conduct.
- Support CSD in the preparation of medical answers to questions from Health Authorities,
- IRB/Ethics Committees, investigators, experts involved in the study/project.
- Develop good quality management practices, including guidelines, as regard to medical review/validation activities.
- Support for regulatory documents filing and archiving. review /validation
- Develop study specific training material for training to Medical Advisors and sites.
- Propose and develop, in coordination with CSD and CTOM/DM, checks for study-specific medical data points, based on protocol efficacy criteria. With CTOM track and follow-up on missing data related to these criteria.
- With CSD, define precisely the critical data, and implement/develop related sections of the Study Risk Management Plan.
- Coordinate medical validation/review activity with CME and GSO from GPE, notably to anticipate and prevent last minute queries or backlog, and ensure a smooth the process
- In collaboration with study team, is in charge of designing, providing cost elements related to the study design and committee work.
- Promote and develop use of electronic tools (A/J review, e-PP) in the context of medical
Education & Qualifications
- MD, Ph.D., Pharm.D., BSN, or similar degree; bachelor's degree considered for candidates with experience. Previous experience in Clinical Research and/or Drug Development (e.g., at least 5 years within pharma industry or CRO).
- Knowledge in ICH, GCP. Fluent in English
- Scientific expertise or interest and ability to learn in the domain of assigned study/project.
- High level of autonomy and motivation
- Quality focused and well organized
- Strong communication skills (verbal and written)
- Ability to handle multiple tasks and to prioritize
- Ability to synthesize the information, good presentation skills
- Excellent decision-making and problem-solving capabilities
- Capability to challenge decision and status quo
- Ability to work autonomously and to efficiently & effectively provide status reports
- Ability to anticipate and timely escalate issues and to define appropriate action plans
- Team and results oriented
- Teaching skills, ability to assist and train others
- Strong English skills (verbal and written if English is the second language)
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
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