Talent.com
This job offer is not available in your country.
Medical lead

Medical lead

Biocon BiologicsBengaluru, Karnataka, India
12 days ago
Job description

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), Clinicaltrials.gov 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
Create a job alert for this search

Lead • Bengaluru, Karnataka, India

Related jobs
  • Promoted
Director of Healthcare Products & Solutions| 15+ Years| Bangalore| Full Time

Director of Healthcare Products & Solutions| 15+ Years| Bangalore| Full Time

Tekgence IncBengaluru, Karnataka, India
We are looking Director of Healthcare Products & Solutions for one of our client in Bangalore Location.Director of Healthcare Products & Solutions. We are launching a new Healthcare vertical focused...Show moreLast updated: 2 days ago
  • Promoted
Abbott - Regional Medical Advisor - Medical Affairs

Abbott - Regional Medical Advisor - Medical Affairs

Abbott Healthcare Pvt. Ltd.Bangalore, India
Main Purpose of the Role : The Experienced Medical Affairs Professional is an individual contributor who operates under limited supervision, applying specialized subje...Show moreLast updated: 25 days ago
  • Promoted
Assoc Medical Data review Manager

Assoc Medical Data review Manager

IQVIABengaluru, Karnataka, India
Job Title / Primary Skill : Associate Medical Data Review Manager.Years of Experience : 2 + Years.Job Location : Bangalore / Thane (Hybrid). Educational qualification : MBBS / MD is a must.Serve as a Subjec...Show moreLast updated: 30+ days ago
  • Promoted
Senior Manager - Medical SME

Senior Manager - Medical SME

ConfidentialBengaluru / Bangalore
CPD : Quality & Operations - external stakeholders for services like tele consult Understanding and improvement of Pharma Order Flow. Catalog : Content Quality development and continuous improvement....Show moreLast updated: 27 days ago
  • Promoted
  • New!
▷ Apply Now : Product Lead- Hospitals

▷ Apply Now : Product Lead- Hospitals

EvenBengaluru, Karnataka, India
Job Title : Product Lead – Hospitals Location : Bangalore (Onsite at Even Hospital, Race Course Road) Reporting to : CEO About Even : Even is reimagining healthcare delivery, and a major part of it...Show moreLast updated: 7 hours ago
  • Promoted
Elevate Now - Lead - Clinical Operations / Medical Affairs

Elevate Now - Lead - Clinical Operations / Medical Affairs

Elevate NowBangalore, India
Key Responsibilities : - Oversee end-to-end clinical operations, ensuring compliance with medical standards and protocols. Manage, mentor, and engage with the doctor network (in-...Show moreLast updated: 1 day ago
  • Promoted
Medical Science Liaison- Oncology

Medical Science Liaison- Oncology

Domnic Lewisbangalore, karnataka, in
Domnic Lewis has been mandated to hire for a Medical Science Liaison – Oncology role with a Global Pharma MNC.Medical Science Liaison – Oncology. MBBS / MD Pharmacology / PhD with extensive experience...Show moreLast updated: 15 days ago
  • Promoted
Techno Functional Lead - CRM / Mobile & Omnichannel - Healthcare Domain

Techno Functional Lead - CRM / Mobile & Omnichannel - Healthcare Domain

RHEA HEALTH CARE PVT LTDBangalore, India
We are seeking a Techno-Functional Lead to drive the CRM, mobile application, and omni-channel technology initiatives for our healthcare single-specialty chain, which operates multiple specialties ...Show moreLast updated: 30+ days ago
  • Promoted
Team Lead - AR ( Medical Billing )

Team Lead - AR ( Medical Billing )

ConfidentialBengaluru / Bangalore
Key Responsibilities and Duties : .As a Team Leader you are responsible for several areas that are key to success for the Omega Healthcare, an outsourced billing service in the U.In this role, you ar...Show moreLast updated: 30+ days ago
  • Promoted
Senior Director

Senior Director

ConfidentialBengaluru / Bangalore, India
Location : Bangalore & Salem, India.Industry : Healthcare / Revenue Cycle Management (RCM).We are seeking an experienced Director / Sr. Director – Medical Billing to lead and scale our medical billing...Show moreLast updated: 29 days ago
  • Promoted
Medical Lead

Medical Lead

Biocon BiologicsBengaluru, Karnataka, India
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 s...Show moreLast updated: 26 days ago
  • Promoted
▷ Apply in 3 Minutes! Assoc Medical Data review Manager

▷ Apply in 3 Minutes! Assoc Medical Data review Manager

IQVIABengaluru, Karnataka, India
Job Title / Primary Skill : Associate Medical Data Review Manager Years of Experience : 2 + Years.Job Location : Bangalore / Thane (Hybrid) Educational qualification : MBBS / MD is a must.Job Overview : ...Show moreLast updated: 30+ days ago
  • Promoted
Director - Medical Coding

Director - Medical Coding

ConfidentialBengaluru / Bangalore
Oversee day-to-day operations and planning of medical coding deliverables.Drive team activities and ensure SLAs for production and quality are met. Handle client escalations and manage communication...Show moreLast updated: 30+ days ago
  • Promoted
Unit Medical Services Head- Bangalore

Unit Medical Services Head- Bangalore

Manipal Hospitals (MHEPL)Bengaluru, IN
Provides clinical and administrative direction for the clinical operation of medical departments and services.Responsible for the co-ordination and oversight of all medical care and support clinica...Show moreLast updated: 4 days ago
  • Promoted
Medical Doctor

Medical Doctor

Amura HealthBangalore, IN
But deep down, you've always known.More truth, happiness, beauty and meaning to the way we live and care.The truth is that science has always been there. But healthcare never touched it as it is ove...Show moreLast updated: 20 days ago
  • Promoted
▷ (Immediate Start) Medical Lead

▷ (Immediate Start) Medical Lead

Biocon BiologicsBengaluru, Karnataka, India
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, IC...Show moreLast updated: 17 days ago
408212 SERM Assoc Medical Director

408212 SERM Assoc Medical Director

ScaleneWorksBengaluru, Karnataka, India
Quick Apply
Provides medical / scientific expertise in the safety evaluation and risk management of key Client assets in clinical development and / or the post-marketing setting. Ensures scientifically sound review...Show moreLast updated: 30+ days ago
  • Promoted
Product Lead- Hospitals

Product Lead- Hospitals

EvenBengaluru, Karnataka, India
Bangalore (Onsite at Even Hospital, Race Course Road).Even is reimagining healthcare delivery, and a major part of it is to create seamless, patient-centric hospital experiences.Our goal is to comb...Show moreLast updated: 2 days ago
  • Promoted
Project Manager - Medical Devices

Project Manager - Medical Devices

ConfidentialBengaluru / Bangalore
Lead and manage planning, execution, and coordination of medical device projects.Oversee staffing and resources to maximize project success. Monitor and adjust project performance, ensuring alignmen...Show moreLast updated: 30+ days ago
  • Promoted
Ophthalmologist (Medical Data Labeling Specialist)

Ophthalmologist (Medical Data Labeling Specialist)

BigRioBangalore, IN
Ophthalmologist (Medical Data Labeling Specialist).BigRio is a Boston-based, remote-first technology consulting firm specializing in advanced data and software solutions. We partner with forward-thi...Show moreLast updated: 30+ days ago