Medico- Marketing / Affairs
Preparation for Product Launch inputs & medical write ups,
Providing scientific solutions to the queries from Filed Force or Practicing Physician
Preparation of Slide decks in line with SOP for various topics
Answering queries from field force in timely manner with regulatory compliance
Preparing on Training Modules for field force and impart training if required
Providing strategic inputs and support towards creation of marketing/brand plans for the existing as well as new product launches
Handling product related scientific queries from Doctors / PMTs
Preparation of promotional and training material in compliance.
Scientific support for various activities like CME / RTM
Preparing Monograph, Medical write ups, and literature of the products for the marketing team
Sharing the latest updates regarding the therapy within the Medical team
Preparation of the newsletters and sharing the latest trends in the therapy, Diagnosis and treatment updates with the team.
Coordinating and conducting the monthly training sessions for the field people.
Managing the project of the clinical trial study.
Thorough knowledge of Literature search and extraction of required articles full text
PSUR and other regulatory Document submission whenever required
Keeping a thorough vigil with Vendor and effectively coordinating with Safety reports and may require to conduct audit the Vendor at regular intervals.
Involved in clinical-trial activities: reviews the pharmacovigilance aspects of protocols and other documents; ensures management of adverse-event case reports; reconciles information in pharmacovigilance and clinical research databases.
Contributes to ensure Regulatory compliance of pharmacovigilance activities
Causality Assessment, labelledness of ICSR, Literature monitoring, CIOMS, Good pharmacovigilance practices (GVP) Module VI effectively.
Regulatory and Clinical Trial
Preparation and review of Pack insert of various products according to SOP which comply with national and international guidelines.
Thorough knowledge of ICH-GCP guidelines, Preparation of CT protocols,IBs, Site feasibility, monitoring and termination visits to various CT centers according to SOP and checklists.
Travel to and monitor clinical trial sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed
Preparing site visit reports and constant touch with PIs
Ensure that only qualified individuals are working as site staff and that they are adequately trained
Ensure data collected is accurate and verifiable
Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study
Act as a mentor to site staff and provide continuous support and guidance
Preparation of Rationale and Justification based on Company requirements.
Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements
Key Skills and Competency
Communication and Interpersonal Skills Ability to build relationships of trust and demonstrate professional ethics.
Problem Solving Ability to assess various situations and develop appropriate solutions.
Very good knowledge of MS office
Decision-Making Ability to make sound judgments and properly assess situations.
Multi-tasking and prioritizing the work based on needs
Ability to keep tight deadlines and work under pressure.
Adhere to all HR policies and procedures, to include all absence policies and procedures
If Job Profile Suits You And Interested In The Opening, Please Mail Your Updated CV on sm*********g@gm**l.com indicating following details,
Regards
Asha
You may speak to Sawant on 8355998***
Keyskills: medical affairs training material regulatory compliance medico marketing clinical research clinical trial scientific promotion literature search sales force trainning