Career as Director in Medical Affairs and Medical Writing at CDSA | Emoluments upto Rs. 1,25,000/- pm

 

Clinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions.  It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.

Post : Director Medical Affairs and Medical Writing

Essential Functions
• Provide medical leadership on clinical trials and clinical study projects
• Serve as medical liaison to clients
• Assist in marketing and sales of products and services
• Provide medical guidance to new service/product development.

Age Criteria : Up to 45 years

Emoluments : Up to Rs. 1,25,000/- per month consolidated

Duration : One year and likely to be continued

Location : CDSA, Faridabad

Responsibilities
Medical Affairs
• Provide medical leadership to clinical trial and clinical study projects
• Participate in clinical review meetings (teleconferences live meeting and or face to face) and document preparation meetings
• Edit responses to IEC and regulatory agencies on adverse events and Serious adverse events
• Review and edit regulatory and safety documents for clinical consistency with data and standard of practice
• Review and edit CSR for clinical consistency with data and standard of practice
• Review all documents assigned for scientifically/ medically relevant issues including drug safety

• Review and sign off technical documents written with respect to medically relevant matters with particular attention to those relating to drug safety
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents
• Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings)
• Provide input as necessary to Feasibility Studies, Data Safety Monitoring Committees (DSMC) and other committees, clinical/ product development planning meetings
• Provide advice and support for site feasibility
• Attend and present materials at internal meetings and investigator meetings
• Solicit expert advice, develop collaborative relationship with key experts and investigators
• Assist in the preparation of client proposals
• Act as medical liaison with clients
• Assist in the development of DSMB charters
• Assist in the development of protocol specific procedure medical manuals
• Engage medical experts as consultants/ advisers in various therapeutic areas as per the need of research project
• Participate in business development activities
• Provide consulting services to assist in the development of new drugs or devices under the direction of the Head of Organisation
• Provide medical leadership in developing quality assurance programs

Medical Monitoring
• Performs the duties of Medical Monitor for all the clinical studies in which CDSA is involved
• Interpretation of single and or grouped adverse events, serious adverse events, drug effect and attribution of causality, and disease condition
• Edit clinical narrative reports describing the event; advise on individual subject cases as identified by the study team and identifying queries for the local monitors to complete.
• Ensure compliance with clinical safety and good pharmacovigilance practices and requirements
• Provide support in preparation of Periodic Safety Update Reports (PSURs)
• Review and sign off Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication),
• Assist the PI and DSM in establishing the presence or absence of clinically meaningful trends and, if noted, assisting in follow up as appropriate with the project team, sponsor, and Regulatory Authorities
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

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