Career as Director in Medical Affairs and Medical Writing at CDSA | Emoluments upto Rs. 1,25,000/- pm
• Takes a leading role in preparing or contributing to the production of any type of clinical document, for either internal CDSA customers or external clients, for investigational drugs, biologicals, or medical devices
• Acts as mentor for less experienced Medical Writers and assists in their training and development.
• Participates in project teams and may provide service as an independent expert. May serve as writing lead and project manager for medical writing projects
• Responsible for developing and managing writing style guides, templates such as, protocols, investigator's brochure, clinical study reports, IND sections
• Proposes applications
• Provides and manages internal and external writing activities
• Responsible for developing or acquiring a document management system, establishing style guides, and generation of templates and processes
• Revise SOPs or suggest process improvements for consideration. May draft new MW SOPs for review and act as reviewer for MW SOPs, as assigned and appropriate.
• Provide medical guidance and therapeutic area training for project team members and staff as required
• Develop training modules for therapeutic areas
• Develop project specific and protocol specific training
• Oversee development of training modules and project specific and protocol specific training in other therapeutic areas
• Be a faculty for training programs conducted by CDSA
Educational Qualifications Essential:
MD in pre-, para- or clinical subjects, preferably clinical or pharmacology background
• Post MD/PhD experience of medical monitoring and medical writing (includes time spent as functional Primary or functional/ technical Lead), experience with a CRO, pharmaceutical, biotechnology, or device company
• experience of drug development and clinical trial administration background
• Experience in safety reporting and management
• Experience in pharmacovigilance, medical coding and systems for adverse event review and reporting is preferred
• Clinical practice experience of at least two years
• Experience of medical monitoring and medical writing experience (includes time spent as functional Primary or functional/ technical Lead) experience with a CRO, pharmaceutical, biotechnology, or device company
• Demonstrated knowledge of drug development activities
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