Job Description

-Design, plan and run clinical trials based on IR-GCP and ICH guidelines to ensure that clinical trial and related activities are performed in accordance with sponsoring agency policies and procedures -Submit regulatory documents to IRB/CTA and register the study at IRCT and prepare any other required regulatory submission documents -Establishing and organizing study files, including study source documents, informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs -Tracking subjects and preparing follow up reports, documenting adverse events -Design, plan and run PSURs, PBRER and RMP based on IR-FDA and ICH guidelines -Mastery over therapy area and allotted product/portfolio and also relevant competitors’ products. -Suggest marketing strategies and interact closely with marketing and sales colleagues to implement the right product positioning and promotional strategies. Foresee the challenges by competitors’ products, activities or changing marketing dynamics and make timely corrective and preventive actions -Ensure that the profile of the suppliers remains high among stakeholders like key opinion leaders (KOLs), Physicians, patients, paramedics, associations. by developing and maintaining a close rapport. Providing them medical support whenever required -Answering medical queries related to supplier’s products raised by doctors and field staff and other internal/ external customers -Educating and training of field and marketing personnel and other internal stake holders regarding all aspects of disease, product and therapy relevant to the promotional strategy. -Plan, organize and actively participate in meetings, workshops, conferences, updates, CMEs -To assist the regulatory affairs personnel in ensuring that all promotional activities and supplier’s products conform to regulatory laws and directions -Identification, development and review of publications/content, relevant to assigned product/portfolio or based on marketing need; suitable for scientific and non-scientific forums and suitable for internal and external customers. -Facilitate and propose strategies for new product launches with close association of marketing and regulatory colleague to achieve the overall corporate objective. -Plan and contribute for generation of new data relevant to product/portfolio assigned; identification and critical evaluation of new data generated by competitor. Review and suggest/ prepare a plan to use this data for effective product promotion -To be key contact person in medico-marketing (MM) activities concern business area/ portfolio/ basket of products -Act in line with ethical standards and company procedures