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5.0 - 10.0 years
10 - 11 Lacs
gurugram
Work from Office
Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical component...
Posted 4 weeks ago
3.0 - 8.0 years
7 - 8 Lacs
mumbai, hyderabad
Work from Office
Minimum 3+ years of relevant project specialist experience. Excellent proficiency in Advanced Microsoft Excel, including Pivot tables,VLOOKUP/XLOOKUP and Complex formulas Lead monthly finance activities and provide financial analysis to support decision-making. Maintain and enhance financial tracking tools and documentation. Collaborate with internal teams and external stakeholders to ensure accurate and timely reporting. Candidate from Hyderabad and Gurgaon preferre d Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies...
Posted 1 month ago
1.0 - 6.0 years
5 - 6 Lacs
hyderabad, gurugram
Work from Office
Minimum 1 year of experience in clinical research and core project management. Strong proficiency in Advanced Microsoft Excel. Support project coordination, reporting, and data management activities. Maintain accurate and up-to-date process documentation. Communicate effectively with internal and external stakeholders. Finance and budgetary knowledge are a plus. Candidate from Hyderabad and Gurgaon preferred Planning, directing, creating, and communicating clinical study timelines, ensuring that all milestones are met and that the project stays on track Gathering input from cross-functional teams, including clinical, regulatory, and data management, to create comprehensive plans for timely d...
Posted 1 month ago
5.0 - 8.0 years
7 - 10 Lacs
kolkata, mumbai, new delhi
Work from Office
Manage DNA Slim protocol, medical reviews & reporting Oversee slimming programs and supervise the team Drive team performance, event participation, and client conversions Ensure scientific planning and tracking of each clientjourney
Posted 1 month ago
1.0 - 6.0 years
12 - 13 Lacs
mumbai
Work from Office
Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards. Drive portfolio/trial medical feasibility within the Global Development framework and provide country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team. Identify and propose new sites for clinical trials, analyse capability, assess patient pool and country treatment landscape, and make recommendations for potential trial inclusion. Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed. Respon...
Posted 1 month ago
1.0 - 6.0 years
3 - 8 Lacs
bengaluru
Remote
Job description 1 Medical to Medical connect with HCPs in the MDR Bacterial Infection Therapy Area 2 Developing regional KOLs. (these are office bearers of district chapters of various medical associations, regional speakers / trend setter at district level, KOLs attached to medical schools). 3 Conducting regional CMEs (from content development to conducting local CMEs). 4 Periodic scientific discussion, journal clubs, latest literature / articles with regional KOLs along with our field force. 5 Support in execution of various product surveillances, epidemiological studies etc 6 Handling product complaints by personally meeting and understanding the case, literature support and helping Dr to...
Posted 1 month ago
5.0 - 10.0 years
7 - 8 Lacs
hyderabad
Work from Office
- Title - Safety & PV Spec I - Experience - 1-2.5 years of PV, experience - Job Location -Office based at Gurgaon / HYD Hybrid - Qualification Education B.Pharm / M.Pharm / BDS / BMS / MBBS (No BSc / MSc) - ICSR Case processing -Spontaneous is mandatory - English communications skill is important - Medical Knowledge - Terminology - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. - Enters data into safety dat...
Posted 1 month ago
2.0 - 7.0 years
10 - 12 Lacs
kochi, kolkata, pune
Work from Office
Our Client: Client operates in the health tech or remote health monitoring industry. It specializes in providing contactless health monitoring solutions using AI-powered sensors to track vital signs like heart rate, respiration, and sleep patterns. Their technology is often used in hospitals and home care settings for continuous, real-time health monitoring and early detection of medical conditions. Job Title: Manager- KOL Engagement Education: Any Graduate Experience: 4 - 7 Years of relevant exp Location: Chennai / Coimbatore About the Role: The Manager - Key Opinion Leader Management will be responsible for engaging with key doctors and healthcare professionals in partner hospitals. This r...
Posted 1 month ago
1.0 - 6.0 years
2 - 6 Lacs
kochi
Work from Office
- Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing educatio...
Posted 1 month ago
0.0 years
0 Lacs
hyderabad, telangana, india
On-site
Summary Location: Mumbai / Hyderabad, India Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. About The Role: As the Clinical Research Medical Advisor (CRMA), your responsibility lies within the development of Global Clinical Trials this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning. You will drive compliance across all aspects of clinical trials and CRMA related activities. It will be ...
Posted 1 month ago
1.0 - 6.0 years
3 - 4 Lacs
kolkata
Work from Office
Responsibilities: Develop and maintain strong relationships with KOLs, academic institutions, medical societies, and other relevant stakeholders in assigned therapeutic areas. Serve as a credible and trusted scientific resource for healthcare professionals, providing accurate and up-to-date information on our products, disease states, clinical data, and treatment guidelines. Identify and engage with potential investigators for company-sponsored clinical trials and support investigator-initiated research studies (IIS) by providing scientific and logistical support. Deliver scientific presentations and educational programs to HCPs, both individually and in group settings, to enhance understand...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
palakkad, kerala
On-site
You will be working as a full-time Medical Records Executive at Ahalia Hospitals in Palghat, Kerala. Your primary responsibility will be to manage and maintain patient records, ensuring accurate and secure storage of medical information. This includes organizing and updating patient files, processing requests for medical records, and ensuring compliance with healthcare regulations and privacy laws. Close collaboration with healthcare professionals is essential to support efficient healthcare delivery and patient care. To excel in this role, you should possess skills in Medical Affairs and Medicine, along with experience in Healthcare Management and Strategic Planning. Proficiency in conducti...
Posted 1 month ago
1.0 - 4.0 years
8 - 13 Lacs
Remote, , India
On-site
Collaboration with Key Opinion Leaders (KOLs): Build and maintain relationships with Leading Specialists to understand customer needs and tailor medical activities accordingly. Engage in round tables , advisory boards , and medical education programs (approximately 20% of your time will be dedicated to direct interactions with KOLs). Medical Affairs Strategy: Contribute to the Medical Affairs Plan , including budget monitoring, by providing strategic input on medical programs, product positioning, and market insights. Be an active member of the cross-functional value team (CVT) and local action team (LAT) . Pre-launch and Post-launch Activities: Develop and implement pre-launch medical strat...
Posted 1 month ago
10.0 - 14.0 years
0 Lacs
maharashtra
On-site
As the companys subject matter expert on drug safety and pharmacovigilance, you will be responsible for ensuring compliance with Local & Global PV-relevant Heath Authority requirements. Your role will involve overseeing PV Contracts, vendor management, and PV system audits/inspections. Additionally, you will develop a good understanding of signal management and benefit-risk evaluation activities. You will be expected to develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures. Acting as the primary safety liaison with country regulatory authorities and internal stakeholders will be a key part of your responsibilities. Collaboration with Clinical Development,...
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
karnataka
On-site
As the Associate Director, Global Channel Analytics at GSK, you will be responsible for tracking, analyzing, and reporting on channel and content performance metrics within the Global Scientific Communications organization. Your role will involve providing actionable insights to optimize scientific communication strategies across therapeutic areas. Collaboration with Digital and Medical teams will be key to integrating generative AI tools into omnichannel content workflows, enhancing engagement, efficiency, and personalization. Your key responsibilities will include tracking, analyzing, and reporting on metrics and analytics across key scientific communication channels to improve channel and...
Posted 1 month ago
5.0 - 10.0 years
5 - 10 Lacs
Hyderabad, Telangana, India
On-site
To provide functional and operational directions to internalize HEOR analysis and comparative effectiveness analysis (meta-analysis, network-meta-analysis, indirect treatment comparison, matching adjusted indirect treatment comparison etc) processes in partnership with Global HEVA / ITC-NMA / Evidence Synthesis / Market Access / Medical teams. People: (1) Support Manager/Team Lead in collaboration with Global HEVA / ITC-NMA / Evidence Synthesis / Market Access / Medical teams to formulate and conduct analysis as per the requirement; (2) Maintain effective partnership with end stakeholders for the allocated GBU and products - with an end objective to develop appropriate comparative efficacy e...
Posted 1 month ago
5.0 - 8.0 years
3 - 6 Lacs
Hyderabad, Telangana, India
On-site
The Pharmacovigilance (PV) Science Expert is a global role, and it supports an international, dynamic, and culturally diverse team dedicated to safety surveillance throughout the product lifecycle of a broad range of products. The PV Science Expert is a safety expert who is responsible for performing core pharmacovigilance activities on a product, in partnership with the Global Safety Lead/Managers (GSLs/GSMs), to identify safety signals, evaluate, and analyze safety data for both marketed products and products in post marketing and clinical development. Accountabilities: -Manages ongoing core signal detection activities for Global Safety Leads/Managers (GSLs/GSMs) review (involve synthesis ...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
haryana
On-site
As a Patient Relations Specialist in Oncology at Vaidam Health, you will play a crucial role in assisting patients and healthcare providers by coordinating appointments, maintaining patient records, and ensuring effective communication throughout the treatment process. Located in Gurugram, this full-time on-site position requires a dedicated individual with a background in Medical Affairs and Medicine, specifically in Oncology. Your responsibilities will include managing patient inquiries, organizing medical travel arrangements, and collaborating with doctors to facilitate pre-treatment consultations and post-treatment follow-ups. Your expertise in patient care coordination, combined with ex...
Posted 1 month ago
0.0 - 2.0 years
0 - 2 Lacs
Bengaluru, Karnataka, India
On-site
We are looking for the Primary scientific face of the organization to Thought Leaders & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities You will be responsible for the engagement of identified key thought leaders through medical affairs activities, in alignment with the overall strategic plan You will be responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects You will be a therape...
Posted 1 month ago
0.0 - 2.0 years
0 - 2 Lacs
Kolkata, West Bengal, India
On-site
We are looking for the Primary scientific face of the organization to Thought Leaders & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities You will be responsible for the engagement of identified key thought leaders through medical affairs activities, in alignment with the overall strategic plan You will be responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects You will be a therape...
Posted 1 month ago
0.0 - 2.0 years
0 - 2 Lacs
Mumbai City, Maharashtra, India
On-site
We are looking for the Primary scientific face of the organization to Thought Leaders & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities You will be responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals. You will have to represent the organization in various internal & external scientific platforms. You will have to gather deep insights on disease trends and treatment patterns from key th...
Posted 1 month ago
0.0 - 2.0 years
0 - 2 Lacs
Delhi, India
On-site
We are looking for the Primary scientific face of the organization to Thought Leaders & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities You will be responsible for the engagement of identified key thought leaders through medical affairs activities, in alignment with the overall strategic plan You will be responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects You will be a therape...
Posted 1 month ago
0.0 - 2.0 years
0 - 2 Lacs
Bengaluru, Karnataka, India
On-site
We are looking for the Primary scientific face of the organization to Thought Leaders & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities You will be responsible for the engagement of identified key thought leaders through medical affairs activities, in alignment with the overall strategic plan? You will be responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects You will be a therap...
Posted 1 month ago
0.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at ht...
Posted 1 month ago
10.0 - 14.0 years
0 Lacs
maharashtra
On-site
As an Associate Director, Study Site Engagement at Takeda, you will play a key role in enhancing engagement and providing added value by establishing and nurturing long-term relationships with investigators and study site personnel. You will support study teams with trial operations from Feasibility through CSR within the assigned region or countries across Takeda therapeutic areas. Your responsibilities will include supporting country and site identification, feasibility, site selection, study recruitment strategies, and mitigating barriers at the direction of Clinical Programs. You will be responsible for Study Specific Engagement activities, such as early engagement for country and site f...
Posted 1 month ago
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