Medical Lead
3 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), 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
-
Clinical Content Developer – Medical
2 days ago
Yelahanka, India BizConnect Events Full timeSubject Matter Expert (SME) — Medical / Nursing Education (VR Training Content) Engagement Type: Full Time / Part-time Consultant (3-month pilot) Location: Flexible / Remote + occasional on-site sessions at XploR Medica, Bengaluru Duration: 12 weeks (extendable based on pilot success) Reporting to: Project Lead – Immersive Training (XploR Medica) Who you...
-
Lead Fpga Design Engineers
3 weeks ago
Yelahanka, India ACL Digital Full timeJob Title: Lead FPGA Design Engineer Experience Required: 7–12 years Location: Hyderabad/Bangalore Job Type: Full-time Industry: Semiconductor / Electronics / Embedded Systems Job Summary: We are looking for a highly skilled and experienced Lead FPGA Design Engineer to join our hardware design team. The ideal candidate will lead the design, implementation,...
-
Telesales Associate
1 week ago
Yelahanka New Town, Bengaluru, Karnataka, India Dynoble Medical Publishing Full time ₹ 2,40,000 - ₹ 3,00,000 per yearMake outbound calls to medical students and professionalsIntroduce and explain our medical education apps and servicesShare product info, generate interest, and follow upMaintain call logs and lead recordsNo targets — focus on quality conversationsJob Type: Full-timePay: ₹20, ₹25,000.00 per monthBenefits:Cell phone reimbursementHealth insuranceLife...
-
Lead Data Scientist T500-19885
3 weeks ago
Yelahanka, India ANSR Full timeANSR is hiring for one of its clients. About 4flow: Headquartered in Berlin, Germany, 4flow provides consulting, software and services for logistics and supply chain management. More than 1300 team members leverage their supply chain expertise and IT know-how to best serve their customers at 20+ locations around the world. 4flow develops and implements lean,...
-
▷ [Only 24h Left] Associate
15 hours ago
Yelahanka, India Indegene Full timeAbout Indegene: We are a technology-led healthcare solutions provider. We combine deep industry expertise with fit-for-purpose technology in an agile and scalable operating model. Many of the leading global healthcare organizations rely on us to deliver effective and efficient clinical, medical, and commercial outcomes every day. From strategy to execution,...
-
(15h Left) Lead Associate
3 weeks ago
Yelahanka, India Hourglass Research Full timeCompany Profile: Hourglass Research is a leading Intellectually Property services firm with offices in San Jose, California and Bangalore, India. The company provides US Patent Drafting & Prosecution, Patent Analytics & Licensing services to multinational companies and startups. We cater to the hi-tech, semiconductor, telecom, software, emerging tech,...
-
Nurse
2 weeks ago
Yelahanka, India Aspire Fertility Center Full timeCompany Overview Aspire Fertility is a leading IVF centre in Bangalore with over 10 years of expertise in reproductive medicine. We are committed to providing compassionate, world-class fertility care and helping couples achieve their dream of parenthood through advanced treatments including IVF, IUI, and ICSI. Position Summary We are seeking a dedicated and...
-
Team Lead, TPA/EDI Implementation and Services
2 weeks ago
Yelahanka, Karnataka, India Paylocity Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob TypeFull-timeDescriptionPaylocity is an award-winning provider of cloud-based HR and payroll software solutions, offering the most complete platform for the modern workforce. The company has become one of the fastest-growing HCM software providers worldwide by offering an intuitive, easy-to-use product suite that helps businesses automate and streamline...
-
Yelahanka, Karnataka, India Life Educare Pvt. Ltd. Full time ₹ 5,50,000 - ₹ 6,60,000 per yearJob Title: Hiring Content WriterLocation: Bangalore, IndiaGet in touch- Kindly share your CV at or Benefits:Performance bonusMedical/health insurance cover, medical health check-up, personal accident coverPension/retirement benefits & gratuity for employees completing 5 years of continuous serviceStaff kids' education subsidyKey ResponsibilitiesDonor Lead...
-
Design Quality Engineer
2 days ago
Yelahanka, India Indegene Full timeWe are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion,...