Medical Lead
2 weeks ago
JOB DESCRIPTION
• Effectively support the Clinical strategy from TPP till submission of the dossier to regulatories like (FDA, EMEA, DCGI,…) in the
• Prepares/Reviews CDP, IB, study protocols, ICF, briefing book for scientific advices, TLFs and CSRs
• Actively work towards approaches for faster completion of trials and having a patient centric approach..
• Provides/Reviews medical inputs for study conduct as per applicable GCP, SOP and regulatory requirements.
• Provides inputs on study level data including GCP-issues report.
• Attends regular meetings with CRO and/or other vendors.
• Supports and oversees activities of study conduct e.g. site selection, interaction with investigators and other service providers.
• Accountable for accuracy of trial information in all trial Registries such as Clinical Trials Registry – India (CTRI), etc.
• Contributes to medical aspects and take part in study initiation and investigator meetings.
• Provides inputs in to protocol deviation decision.
• Medical monitoring which includes data reviews, EDC reviews.
• Oversees CRO and conducts study specific medical monitoring which includes review of daily lab alerts and SAEs to communicate with CRO regarding follow-up.
• Supports audits and inspections.
• Monitors safety of subjects participating in clinical trials.
• Supports pharmacovigilance department in preparing safety documents.
• Supports statistics team in the conduct of Data Safety Monitoring Board interim analysis meetings.
• Prepares/Reviews IND / IMPD medical documents, annual updates, MAA/CTD and other regulatory
• Supports in DBL (provide inputs on Tables, Listings and Figures, actively participate DBL meetings).
• Prepares/Reviews Protocol Synopsis, Safety forms etc.
• Prepare/ Reviews study documents e.g. SAP, DMP, SMP, DSMB charter, MMP, Imaging charter.
• Provides inputs on final TLFs, works with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings.
• Support Regulatory scientific meetings and MAA approvals (USFDA/EMA/PMDA/CDSCO and other regulatory authorities across different regions and countries) for clinical aspects.
• Supports in Handling of Regulatory, Marketing or any other molecule-related queries
• Supports department activities like SOP preparation and review / external potential partner scientific discussions / consultant interaction.
• Supports in the dissemination of important scientific information through articles or presentations or training.
• Performs other related duties as assigned.
• Provide scientific /Medical rationale or justification on specific products or therapy area
-
Medical Lead
3 days ago
Bengaluru, Karnataka, India Biocon Biologics Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJOB DESCRIPTION• Effectively support the Clinical strategy from TPP till submission of the dossier to regulatories like (FDA, EMEA, DCGI,) in the• Prepares/Reviews CDP, IB, study protocols, ICF, briefing book for scientific advices, TLFs and CSRs • Actively work towards approaches for faster completion of trials and having a patient centric approach.....
-
Sales Executive
2 weeks ago
Bengaluru, Karnataka, India Sanare Medical Full time ₹ 6,00,000 - ₹ 12,00,000 per yearSanare Medical – Bangalore, India (On-site)About the jobSanare Medical is looking for a dynamic Sales Executive to promote cutting-edge robotic physiotherapy & neuro-rehabilitation equipment. Location: Bangalore (with travel across India) Experience: 2–5 years in medical device salesWhat you'll do:• Build relationships with physiotherapists,...
-
Continuous Improvement Operations Lead
1 week ago
Bengaluru, Karnataka, India Fresenius Medical Care Full time ₹ 12,00,000 - ₹ 36,00,000 per yearFresenius Medical Care core values:Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our...
-
Medical Writer
16 hours ago
Bengaluru, Karnataka, India vueverse Full time ₹ 12,00,000 - ₹ 36,00,000 per yearOverview: The Medical Writer will be responsible for researching, creating, and editing a wide range of clinical research documents. This role includes acting as the lead writer or submission coordinator for projects, managing the contributions of multiple writers, and serving as the primary client contact. Additionally, the Senior Medical Writer will play...
-
Medical Representative
2 weeks ago
Bengaluru, Karnataka, India Career Point Edutech Limited Full time ₹ 3,00,000 - ₹ 6,00,000 per yearKey ResponsibilitiesPromote and sell pharmaceutical products to doctors, pharmacists, and healthcare professionals.Build and maintain strong relationships with medical practitioners and chemists.Conduct product presentations and detailing to healthcare providers.Achieve monthly sales targets and expand market share in assigned territory.Monitor competitor...
-
Medical Safety Advisor
2 weeks ago
Bengaluru, Karnataka, India IQVIA Full time ₹ 12,00,000 - ₹ 36,00,000 per yearSenior Medical Safety Advisor Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as...
-
Team Lead, Medical Billing
3 days ago
Bengaluru, Karnataka, India ScribeEMR Systems Private Limited Full time ₹ 7,00,000 - ₹ 15,00,000 per yearWork Location: Office-based working.Work Timings: US Day shift (Indian Night shift). Flexible depending upon client requirements.Qualifications and Skillsets Required:a. Any graduation with overall 5 to 7 years of prior experience in Charge entry, Payment posting, prior authorization, Denial Management, and AR follow-up. b. Minimum Team Lead experience 3 to...
-
Medical Writer
1 week ago
Bengaluru, Karnataka, India Trigent Software - Professional Services Full time ₹ 12,00,000 - ₹ 24,00,000 per yearPosition:Senior Medical Writer – RWELocation:BangaloreJob Type:Full-timeDepartment:Medical Writing – MCAPLJob DescriptionTheSenior Medical Writer – RWEwill be responsible for authoring, reviewing, and managing high-quality scientific and regulatory documents. The role requires strong scientific understanding, writing expertise, and the ability to lead...
-
Bio Medical Engineer
4 days ago
Bengaluru, Karnataka, India Apollo HomeCare Full time US$ 50,000 - US$ 1,00,000 per yearRole & ResponsibilitiesResponsible for sales and services of Medical equipment2-3 yrs of experience in medical equipment salesShould convert online leads for medical equipmentWork on other related jobs to be given from time to timeHave handled service as well as equipment salesGood understanding of Medical equipment salesNote : Bike is Mandatory
-
Medical Superintendent
1 week ago
Bengaluru, Karnataka, India Maharaja Agrasen Hospital Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Summary:The Medical Superintendent is the senior-most clinical-administrator in the hospital responsible for overseeing the entire medical and clinical operations, ensuring high quality patient care, regulatory compliance, efficient functioning of departments, and aligning clinical services with the hospital's mission and strategic objectives.Key...