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30.0 years
2 - 8 Lacs
Hyderābād
On-site
Job Summary : Medpace, a rapidly growing global Clinical Research Organization (CRO), is excited to announce that we’re looking for experienced professionals to join us as we prepare to launch of our newest office in Hyderabad, India . This is more than just a job. It’s an opportunity to be part of something from the very beginning. You’ll play a direct role in shaping the culture, building the team, and influencing how we grow in India. From day one, your work will make a meaningful impact across global projects. Why Join Medpace in Hyderabad? Be a Founding Member : Help establish and lead operations at our newest location. Immediate Impact : Your experience will directly influence Medpace’s growth in the region. Career Growth : As the office grows, so will the leadership and advancement opportunities. Global Reach : Work on cutting-edge clinical trials with international teams and top-tier sponsors. Strong Culture : Join a company known for its stability and commitment to professional development. Support & Infrastructure : While the Hyderabad office is new, you’ll be backed by the global resources and processes of a well-established CRO. If you’re looking for a new challenge, and want to be part of building something meaningful while advancing your career with a company that’s investing in your region — we’d love to hear from you. Help shape the future of Medpace in Hyderabad. Apply today. Responsibilities : Collect, analyze and document user requirements; Design, modify, develop and support software applications; Participate in software validation process through development, review, and/or execution of test plan/cases/scripts; Create software applications by following software development life-cycle, which includes requirements gathering, design, development, testing, release, and maintenance; Communicate with team members regarding projects, development, tools, and procedures; Utilize skills in development areas including object oriented programming (C#), databases (SQL) web applications (ASP.NET); and Potential opportunities to lead software development projects. Qualifications : Bachelor's Degree in Computer Science; Familiarity of technologies such as C#, Angular, Webservices, Git, relational databases; Experience in Entity Framework, Azure DevOps is advantageous; Understanding of software development life cycle (SDLC) and software release management; Prior experience modernizing systems to a cloud-based platform (Azure) is a plus; Excellent analytical, written and oral communication skills in English; and Prior experience developing mobile application (iOS/Android) is a plus. Medpace Overview : Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? : People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets
Posted 10 hours ago
0.0 years
0 Lacs
India
On-site
Job Details Department Doctors Career Level Consultant-Endocrinologist Total Years Experience 0 - 3Years Gender Any Job Location Pallikaranai Quaification DM/MBBS/MD Physician Job Description Roles and Responsibilities Consultant Endocrinology • Analyzing, examining, and investigating patients and their medical histories for signs and symptoms of hormonal imbalances. • Advising, ordering, and performing tests and interpreting the results. • Discussing diagnoses with patients, explaining treatment options, and giving advice on medications, lifestyle and dietary changes, and other preventative measures. • Carrying out follow-up appointments, monitoring patient progress, adjusting treatment plans and medications, and updating patient records. • Supporting patients with serious or complex endocrine conditions and their loved ones. • Conducting research and studies on the endocrine system and its diseases, disorders, and conditions to develop new treatment techniques. • Remaining up-to-date on current discoveries, developments, trends, research, and technology. • Handling basic administrative, clerical, and business tasks, such as filing, answering phones, or data entry. Desired Candidate Profile • Qual: MBBS + MD/DNB /DM Endocrinology • A thorough understanding of the endocrine system and its diseases, disorders, and conditions. • Strong analytical abilities to provide accurate diagnoses. • Excellent decision-making, interpersonal, and communication skills. • Strong organizational, problem-solving, and researching skills. • Proficiency with computers and medical equipment. Perks and Benefits As per Market standard Specialisation Endocrinology
Posted 10 hours ago
30.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Medpace, a rapidly growing global Clinical Research Organization (CRO), is excited to announce that we’re looking for experienced professionals to join us as we prepare to launch of our newest office in Hyderabad, India . This is more than just a job. It’s an opportunity to be part of something from the very beginning. You’ll play a direct role in shaping the culture, building the team, and influencing how we grow in India. From day one, your work will make a meaningful impact across global projects. Why Join Medpace in Hyderabad? Be a Founding Member: Help establish and lead operations at our newest location. Immediate Impact: Your experience will directly influence Medpace’s growth in the region. Career Growth: As the office grows, so will the leadership and advancement opportunities. Global Reach: Work on cutting-edge clinical trials with international teams and top-tier sponsors. Strong Culture: Join a company known for its stability and commitment to professional development. Support & Infrastructure: While the Hyderabad office is new, you’ll be backed by the global resources and processes of a well-established CRO. If you’re looking for a new challenge, and want to be part of building something meaningful while advancing your career with a company that’s investing in your region — we’d love to hear from you. Help shape the future of Medpace in Hyderabad. Apply today. Responsibilities Collect, analyze and document user requirements; Design, modify, develop and support software applications; Participate in software validation process through development, review, and/or execution of test plan/cases/scripts; Create software applications by following software development life-cycle, which includes requirements gathering, design, development, testing, release, and maintenance; Communicate with team members regarding projects, development, tools, and procedures; Utilize skills in development areas including object oriented programming (C#), databases (SQL) web applications (ASP.NET); and Potential opportunities to lead software development projects. Qualifications Bachelor's Degree in Computer Science; Familiarity of technologies such as C#, Angular, Webservices, Git, relational databases; Experience in Entity Framework, Azure DevOps is advantageous; Understanding of software development life cycle (SDLC) and software release management; Prior experience modernizing systems to a cloud-based platform (Azure) is a plus; Excellent analytical, written and oral communication skills in English; and Prior experience developing mobile application (iOS/Android) is a plus. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets
Posted 1 day ago
5.0 years
1 Lacs
Navi Mumbai, Maharashtra, India
Remote
Our imaging services are growing rapidly, and we are currently seeking a full-time, office-based Medical Physicist to join our team in Mumbai. If you want an exciting career where you will use your previous education and expertise to develop and grow your career even further, then this is the opportunity for you. You will work as part the Medpace Imaging Core Laboratory team. Responsibilities Advice and review relating to radiation dosimetry and nuclear imaging on clinical trial protocols proposed by sponsors Design of imaging and dosimetry measures for use with diagnostic or therapeutic radionuclides Perform quality assurance checks on nuclear imaging and dosimetry data to ensure protocol specific requirements are met Scanner calibration by the analysis of phantom scans and calculation of the dosimetry conversion factor Image reconstruction and analysis (PET/CT, SPECT/CT and/or planar nuclear imaging) Dosimetry calculation (%ID/g, biological half-life, TIAC, estimated dose) in normal organ and tumor tissues using off the shelf and proprietary software Ensure compliance with MIRC and ICRP guidelines for radiation safety protection Compile and maintain project-specific status reports and project timelines associated with imaging components of clinical trials Perform project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols. Qualifications PhD or Master degree in physics or in other relevant field with at least 5 years’ experience in dosimetry calculation for internal radiotherapy (PRRT) Or PhD degree in physics or in other relevant field with at least 2 years’ experience in dosimetry calculation for internal radiotherapy (PRRT) Expertise in quantitative image reconstruction (nuclear medicine images) Expertise in internal radiotherapy and dosimetry calculation using MIRD S-values, 3D-RD and/or OLINDA/EXM 1.0 software Experience with internal radiation dosimetry for gamma, positron and alpha emitting radionuclides would be favored Experience working with clinical trials or within the pharmaceutical environment is preferred. Compensation A target salary range of $90,000-$150,000/year, dependent. Your compensation will be based on your skills and experience. Medpace offers the following benefits for eligible positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, and pet insurance. For more details, please discuss with your recruiter. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 1 day ago
3.0 years
3 - 4 Lacs
Bengaluru, Karnataka, India
On-site
About Even Healthcare Even Healthcare is revolutionizing the healthcare industry by providing comprehensive and affordable healthcare solutions. We are on a mission to create a seamless healthcare experience for individuals and families by building a strong network of healthcare providers. Job Summary We are seeking a detail-oriented and experienced Medical Transcriptionist to join our healthcare documentation team. The role involves transcribing and editing medical reports, dictated by physicians and other healthcare practitioners, into accurate, formatted, and timely documents for electronic health records (EHR). It also involves extracting key medical data from unstructured medical records, aiding in the mission to organise health data across India, which will give Even more insights into population health statistics and allow us to be able to make the most impactful clinical interventions to improve health outcomes. Key Responsibilities Review scanned or photographed handwritten notes, discharge summaries, lab reports, prescriptions, and consult letters. Identify and extract key structured data points such as diagnosis, medications, dosages, tests ordered, and procedures performed.Enter extracted data into designated templates or EMR systems accurately and consistently. Documentation Review & Support: Flag inconsistencies, missing information, or unclear entries for clinical clarification. Collaborate with clinical teams, case managers, or coders for validation of unclear terms or abbreviations. Compliance & Confidentiality: Ensure strict adherence to HIPAA and organizational policies regarding patient data. You must maintain a high standard of data accuracy and confidentiality at all times Qualifications Prior experience in medical transcription or clinical data extraction (1–3 years preferred). Strong grasp of medical terminology, anatomy, pharmacology, and healthcare documentation standards. Proficiency in transcribing from audio and reading varied handwriting styles in medical contexts. Comfortable using EMR/EHR systems and transcription tools (e.g., M*Modal, eScription). High typing speed (60+ WPM) and strong accuracy in data entry. Familiarity with diagnostic codes (ICD), procedure codes (CPT), and medication names is a plus. Must have Strong attention to detail and ability to prioritize accuracy under time pressure. Ability to work independently, manage time well, and meet tight deadlines. Familiarity with specialties like internal medicine, cardiology, endocrinology, or surgery. Skills: diagnostic codes (icd),documentation,transcription,anatomy,data entry,transcription tools,medical transcription,pharmacology,emr/ehr systems,data,clinical data extraction,medication names,healthcare,medical terminology,procedure codes (cpt)
Posted 2 days ago
2.0 - 4.0 years
25 - 27 Lacs
Bengaluru
Work from Office
Aster Medcity is looking for Senior Specialist Paediatric Endocrinology, to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes
Posted 3 days ago
1.0 years
5 - 9 Lacs
India
On-site
We require a gynaecologist in a specialty hospital like Eraya fertility, located at film Nagar Road Number 4, Hyderabad, plays a crucial role in women's health care. responsibilities include the following: 1. Routine Women's Health Care Preventive Care: Conducting regular check-ups, Pap smears, breast exams, and pelvic exams to detect early signs of gynaecological diseases. 2. Diagnosis and Treatment of Gynaecological Conditions Reproductive Health Issues: Treating conditions like fibroids, endometriosis, ovarian cysts, and sexual organ related infections (STIs). Menstrual Disorders: Managing issues related to irregular or painful periods, heavy bleeding, and other menstrual cycle abnormalities. 3.Fertility Treatments: Assisting with fertility issues through procedures like in vitro fertilization (IVF), egg retrieval, or hormone therapy. 4. Collaborating with Other Specialties Endocrinology: For managing conditions like diabetes or thyroid disorders in pregnancy. Oncology: For diagnosing and treating gynecological cancers such as ovarian, cervical, or uterine cancers. Urology: In cases involving pelvic floor disorders or urinary incontinence in women. 6. Education and Counseling Patient Education: Informing women about sexual health, menopause, and reproductive health. Counseling: Offering emotional support for issues like infertility, miscarriage, genetic counselling Overall, we expect gynaecologist at Eraya Fertility to ensure comprehensive care for women throughout different stages of their lives, working in tandem with other specialists for holistic patient management. Job Type: Full-time Pay: ₹45,646.08 - ₹70,000 per month Benefits: Paid sick time Schedule: Day shift Rotational shift Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: Jubilee Hills Job Types: Full-time, Permanent Pay: ₹45,000.00 - ₹80,000.00 per month Benefits: Flexible schedule Leave encashment Paid time off Schedule: Day shift Supplemental Pay: Overtime pay Performance bonus Shift allowance Education: Bachelor's (Required) Experience: Physician: 1 year (Preferred) total work: 1 year (Preferred) Work Location: In person
Posted 3 days ago
7.0 - 11.0 years
8 - 12 Lacs
Mumbai
Work from Office
Select with space bar to view the full contents of the job information. Senior Specialist - Quality Hypercare (Biosimilars QC) Job Details | AdvanzPharma We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Specialist - Quality Hypercare (Biosimilars QC) Andheri (East), IN, Mumbai 400 ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About the Role The Senior Specialist, Biosimilars will provide technical support to the Associate Director, Biosimilar Quality on all aspects of biological products and the development and enhancement of the Pharmaceutical Quality System to ensure it meets Health Authority expectations. The portfolio will consist of a range of products including in-licensed and development projects. This role will involve exposure to management across the business and requires an individual with a dynamic and collaborative approach. The maintenance of the Pharmaceutical Quality System to ensure it remains fit for purpose with respect to Biologics/Biosimilar products. To support the Associate Director, Biosimilars and the Strategic Quality team in the assessment of several new pipeline products in support of ADVANZ PHARMA s strategic initiatives and objectives. Support the necessary Quality activities to ensure on time delivery and launch of all pipeline projects. Proactively identify and highlight potential Quality risks, hurdles or issues which may impact project scope, and ensure practical resolution or escalation where necessary. Participate during the interactions with Competent Authorities (EMA, National EU Authorities, Health Canada, TGA and others). Address issues/requests by the Agency during MAA. Support in the preparation for Quality Review Meetings with our partners, escalating risks/issues appropriately to remove barriers to success or advise of delays and other changes which may impact Quality and or supply. Provide QA oversight of analytical method development, validation, qualification, and transfer activities for the biologic/biosimilar portfolio. Review protocols and reports for analytical method validation, comparability studies, and bioassays (e.g., potency, identity, purity, and stability). Evaluate and support resolution of laboratory investigations, OOS/OOT results, and method performance issues. Collaborate with external testing partners to ensure analytical approaches meet regulatory and scientific expectations for biologics/biosimilars. Act as subject matter expert in support of the Quality team in the review of Quality System records, incidents and changes. Review analytical methods, procedures, protocols Perform and oversee the lot disposition process Perform change control assessments including document management Review and approve/reject change controls Approve Deviations and CAPAs and ensure all they are appropriately documented and investigated to determine and address root cause Perform detailed risk assessments Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Tertiary qualification in any discipline within Life sciences or Pharmaceuticals Additionally professional qualifications. Knowledge, Skills & Experience: Must be a subject matter expert in quality assurance of Biosimilars, with significant relevant experience. Should possess strong experience in biopharmaceutical active substance production and analytics. Experience working with Biologic and Biosimilar applications Experience interacting with EU regulatory authorities Scientific advice meetings Broad knowledge and awareness of the European regulatory guidelines and legislation. Have a good understanding of early development and validation programs for Biosimilars. Excellent people management skills. Sense of urgency / willingness to operate within tight deadlines. Ability to work with colleagues across a broad range of disciplines and functions. Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others. A positive and can-do approach, biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. *Please include a CV and Cover letter. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. Provider Description Enabled We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data centre "JSESSIONID" is placed on the visitors device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another
Posted 4 days ago
3.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description The Associate, Documentation Management plays a key role in maintaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position supports integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, ensuring adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11. Principle Responsibilities Maintain and support a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal procedures. Support the validation, integrity, and ongoing compliance of electronic quality systems, including document management platforms. Support the Documentation Management System, ensuring all controlled documents (e.g., SOPs, policies, work instructions) are accurately authored, reviewed, approved, and updated per lifecycle requirements. Oversee document lifecycle activities, ensuring all documentation meets GxP and regulatory standards. Support the development, maintenance, and delivery of a GxP training program to ensure relevant personnel remain current with quality and compliance standards. Participate in continuous improvement initiatives aimed at enhancing the effectiveness of quality systems and documentation processes. Assist in the management and execution of the Computer System Validation (CSV) program, ensuring alignment with 21 CFR Part 11, EU Annex 11, and applicable internal validation policies. Support internal and external audits and regulatory inspections by ensuring documentation and systems are readily accessible and compliant. Qualifications And Education Requirements Bachelor’s degree in Life Sciences, Pharmacy, Quality, or a related field. 1–3 years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry. Understanding of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulations. Familiarity with electronic Document Management Systems and Computer System Validation practices. Strong attention to detail and organizational skills By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Posted 4 days ago
0 years
0 Lacs
India
Remote
Role Description This is a full-time remote role for a Consultant Doctor. The Consultant Doctor will be responsible for diagnosing and treating patients with diabetes, developing personalized treatment plans, monitoring patient progress, and collaborating with a multidisciplinary team to provide comprehensive care. The Consultant will also engage in ongoing professional development and research to stay current with the latest advancements in diabetes care. Qualifications Strong clinical skills in diagnosing and treating diabetes Experience in developing personalized treatment plans Excellent communication and patient education skills Ability to collaborate with a multidisciplinary team Strong research and professional development skills Board certification in Endocrinology or a related field MD or DNB degree with a valid medical license Experience with telemedicine is a plus Note : As this is a part-time Job, we are looking for a minimum of 2 hrs per day.
Posted 4 days ago
0.0 - 5.0 years
80 - 125 Lacs
Rohtak, Amritsar, Delhi / NCR
Work from Office
Gastroenterologist Required at Near Delhi Fresher Preferred to Learn ERCP & EUS Team Work Rohtak Haryana Salary 6 Lakhs + Accommodation Amritsar Punjab Salary 6 to 8 Lakhs Gurdaspur Punjab Salary 6 to 8 Lakhs + Accommodation Required Candidate profile Pathankot Punjab Salary 6 to 8 Lakhs + Accommodation Lucknow UP Salary Rs 5 to 6 Lakhs Bathinda Punjab Salary Rs. 5 to 6 Lakhs + Share Team Work Fresher Preferred to Learn ERCP
Posted 6 days ago
5.0 years
0 Lacs
Mumbai Metropolitan Region
On-site
This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Strategic Responsibilities Life Cycle Management: Lead the life cycle of existing brands and newly launched products, crafting and executing growth plans that propel our business forward. Strategy Development: Develop a visionary strategy roadmap for our rare disease portfolio, increasing our business impact and solidifying our position as industry leaders. Brand Plan Execution: Drive brand plans and spearhead multi-channel marketing initiatives, leveraging customer insights to create compelling campaigns. Analytics Utilization: Harness the power of analytics to assess business trends, deploy growth strategies, and mitigate risks. Financial Accountability: Oversee the financial aspects of our brands, including revenue, promotional budgets, and profitability. Stakeholder Identification: Identify and engage key stakeholders to expand our business opportunities and develop strategic partnerships. New Product Launch Responsibilities Business Opportunity Identification: Discover new business opportunities and develop proposals that capitalize on current market trends and therapy area landscapes. Strategy and Execution: Prepare and execute strategies that address unmet needs in the therapy area, ensuring successful product launches. Stakeholder Collaboration: Collaborate with internal and external stakeholders to develop and implement new product launch strategies. Capability Building: Identify and address the needs of stakeholders, developing strategies with measurable outcomes to enhance their capabilities. Operational Responsibilities Implementation Plan: Define and implement brand strategies, monitor SLAs with stakeholders to ensure seamless execution. Marketing Campaigns: Design creative marketing campaigns, cascade them to target customers, and train the sales force to maximize impact. External Liaison: Partner with external agencies to deliver brand initiatives that resonate with our audience. Performance Monitoring: Utilize tools to monitor business performance and the external environment, taking corrective actions as needed. Budget Utilization: Strategically plan and allocate marketing budgets to maximize return on investment. Sales Team Support: Provide timely insights to the sales team, ensuring brand health and achieving market share, sales, and profit objectives. Scientific Relationships: Foster and maintain scientific relationships with KOLs, medical societies, government institutes, and centers of excellence. Field Visits: Conduct regular field visits to gather customer insights and ensure the effective implementation of marketing plans. Compliance Responsibilities Process Compliance: Ensure adherence to Pfizer policies and industry guidelines in the execution of brand strategies. Content Validation: Collaborate with the Medical and Marketing teams to validate content. Risk Assessment: Perform periodic risk assessments and define mitigation plans for programs and campaigns. Regulatory Adherence: Comply with regulatory guidelines while designing brand campaigns. Basic Qualifications MBA in Marketing Over 5 years of experience in Brand/Product management, preferably in Rare Diseases, Endocrinology, or other specialized innovative therapy areas. Strong understanding of the Indian healthcare market and pharmaceutical industry. Experience working with government stakeholders and key business decision-makers. Proven track record in endocrine, hematology, hemophilia, and bleeding disorders. Ability to work in a matrix organization and develop structured project plans. Commitment to the highest ethical standards. Expertise in multi-channel marketing and stakeholder engagement. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Marketing and Market Research
Posted 6 days ago
7.0 years
0 Lacs
India
Remote
Location : Remote (India-based) | Experience : 3–7 years Job Type : Full-Time | Department : Business Development About FriskaAi FriskaAi is transforming chronic care and preventive health through AI-powered, personalized care plans. We partner with clinics across the U.S. to support patients with diabetes, thyroid, and metabolic disorders—leveraging real-time health data, clinical insights, and virtual care teams. The Opportunity We’re seeking an experienced U.S. Healthcare Partnerships Manager to drive FriskaAi’s growth by engaging and onboarding U.S.-based endocrinologists, diabetologists, and GP clinics. This role requires deep familiarity with the U.S. healthcare landscape , exceptional communication (native or U.S. accent), and a proven track record in healthcare sales, business development, or clinic outreach . What You’ll Do Lead end-to-end U.S. clinic partnerships : Identify, prospect, and onboard clinics via targeted outreach (calls, emails, LinkedIn). Conduct high-impact demos : Deliver polished, persuasive virtual/recorded product demonstrations to physicians and practice decision-makers. Drive conversions : Own the sales cycle from initial contact to signed partnership, ensuring seamless handoff to onboarding teams. Collaborate cross-functionally : Work with product, marketing, and support teams to tailor solutions for U.S. clinic needs. Track and optimize : Monitor KPIs (conversion rates, pipeline growth) and refine strategies based on market feedback. Who You Are 3–7 years in U.S. healthcare sales/BD : Prior experience selling to or engaging U.S.-based physicians , clinics, or healthcare SaaS (endocrinology/diabetes care preferred). Exceptional U.S. communication skills : Flawless English with a U.S. accent ; ability to build rapport with clinicians and navigate objections confidently. Tech-savvy relationship-builder : Experience with CRM tools (e.g., Salesforce), virtual demos (Zoom, Teams), and outreach automation. Self-starter : Proven ability to work independently in a remote role and meet targets in a fast-paced environment. Passion for healthcare innovation : Familiarity with AI/digital health tools and chronic care workflows is a plus. Why Join FriskaAi? Competitive salary + performance bonuses Equity options in a high-growth healthtech company Remote-first culture with flexible hours Career growth : Lead U.S. expansion efforts and scale your role with the company. Impact : Help redefine chronic care delivery for thousands of patients. If you’re a U.S.-focused healthcare business developer with the drive to transform clinics through AI, Apply Now.
Posted 6 days ago
12.0 years
0 Lacs
New Delhi, Delhi, India
On-site
Company Description VETLAB, a division of ALL VET DIAGNOSTIC SOLUTIONS PVT LTD, has been a pioneer in veterinary diagnostics and imaging for over 12 years. With multiple centers across India, VETLAB is a recognized and trusted name in the industry, known for its commitment to accurate and reliable diagnosis. We are the first privately managed veterinary laboratory in India accredited by NABL, adhering to ISO/IEC 17025:2005 standards for biological testing. Our extensive range of services includes haematology, biochemistry, parasitology, serology, microbiology, clinical pathology, histopathology, endocrinology, molecular diagnosis, digital X-rays, and ultrasonography. Role Description This is a full-time, on-site role for a Veterinary Radiologist, located in New Delhi. The Veterinary Radiologist will be responsible for performing and interpreting diagnostic imaging studies, including digital X-rays and ultrasonography. Day-to-day tasks include evaluating imaging results, conducting diagnostic procedures, maintaining imaging equipment, and collaborating with veterinary practitioners to ensure accurate and timely diagnosis. The role involves directly interacting with clients and providing consultative support to enhance patient care. Qualifications Proficiency in performing and interpreting digital X-rays and ultrasonography Strong diagnostic skills in clinical imaging and pathology Ability to operate and maintain imaging equipment Excellent communication and consultative skills Experience in collaborating with veterinary practitioners and clients BVSc degree (MVSc preferred) with specialization in radiology
Posted 6 days ago
0.0 - 5.0 years
70 - 125 Lacs
Bharatpur, Lucknow, Tohana
Work from Office
Cardiologist Required at Tohana Haryana Salary 8 Lakhs + Share + Accommodation Bharatpur Rajasthan Salary 10 Lakhs + Share + Accommodation Goalpara Assam Salary 10 Lakhs + Share + Accommodation Rohtak Haryana Salary 8 Lakhs + Required Candidate profile Bathinda Punjab Salary 6 Lakhs + Share + Accommodation Gurdaspur Punjab Salary 7 to 8 Lakhs for 5 Years + Experience Hoshiarpur Punjab Salary 8 Lakhs + Accommodation + Share
Posted 1 week ago
0 years
0 Lacs
Udaipur, Rajasthan, India
On-site
Company Description Established in 1949, Dr Lal PathLabs is the largest and most respected diagnostic service provider in India. With a proven track record of over six decades, it adheres to international standards and benchmarks. The company operates over 190 labs and more than 2000 centers across India, serving over 13 million customers annually. Dr Lal PathLabs offers the widest range of tests and panels in various disciplines, including Molecular Diagnostics, Biophysics, Endocrinology, and Oncology. It is India's most accredited laboratory, with certifications from CAP, NABL, and ISO 9001:2000. Role Description This is a full-time, on-site role for an Area Sales Manager, based in Udaipur. The Area Sales Manager will be responsible for managing and expanding customer accounts, developing business plans, providing excellent customer service, and analyzing market trends. The role includes managing key accounts and ensuring customer satisfaction through effective account management. Qualifications Strong Analytical Skills to understand and interpret market trends Experience in Account Management and managing Key Accounts Proficiency in Business Planning and strategy Excellent Customer Service skills Effective communication and interpersonal skills Ability to work well under pressure and meet sales targets Bachelor's degree in Business, Marketing, or related field is preferred Experience in the healthcare industry is a plus
Posted 1 week ago
3.0 years
0 Lacs
Hyderabad, Telangana, India
Remote
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description Our Digital team at Azurity is building new capabilities utilizing cutting-edge Salesforce systems. We are looking for a dynamic, change inspired, Individual self-driven hands-on Team Member. The Salesforce Developer – Life Sciences is responsible for designing, developing, and optimizing Salesforce solutions to support Azurity pharma. This role focuses on customizing Salesforce platform ensuring seamless HCP/HCO engagement, sales rep support, regulatory compliance, and commercial operations. The ideal candidate will collaborate with onshore architects, business analysts, and stakeholders to develop scalable, high-performing Salesforce solutions while maintaining compliance with HIPAA, GDPR, Sunshine Act, and FDA regulations. Principle Responsibilities Salesforce Development & Customization Develop and enhance Life Sciences-specific CRM functionalities in Salesforce platform and Sales Cloud to support HCP/HCO engagement, Commercial Operations, KOL (Key Opinion Leader) management, and field rep journeys. Customize Salesforce objects, Apex triggers, Lightning Web Components (LWC), Visualforce pages, and declarative automation (Flows, Process Builder). Implement consent tracking, call planning, sample management, and omnichannel engagement workflows for field reps, MSLs (Medical Science Liaisons), and sales teams. Ensure territory management, commercial operations, and compliance tracking are seamlessly integrated into Salesforce. Performance Optimization & Security Optimize Apex code, SOQL queries, and Lightning Web Components for scalability and high performance. Implement role-based security, audit logs, and field-level encryption to maintain compliance with HIPAA, GDPR, and FDA regulations. Conduct code reviews, unit testing, and debugging to ensure high-quality solution delivery. Collaboration & Agile Development Work closely with onshore architects, business analysts, and product owners to gather requirements and translate them into technical solutions. Participate in scrum meetings, sprint planning, and UAT (User Acceptance Testing) as part of an Agile team. Provide technical documentation and deployment support for Salesforce enhancements. Continuous Improvement & Best Practices Stay updated with Salesforce releases, Life Sciences Cloud advancements, and best practices. Implement Salesforce DevOps methodologies, using tools like Gearset, Copado, Jenkins for CI/CD automation. Preferred Skills And Experience 3+ years of experience in Salesforce development, preferably in Life Sciences or Healthcare. Expertise in Salesforce Health Cloud, Sales Cloud, or Veeva CRM Proficiency in Apex, Lightning Web Components (LWC), Visualforce, SOQL, and API development. Hands-on experience with Salesforce APIs (REST, SOAP), middleware tools (MuleSoft, Informatica, Boomi), and data migration. Hands-on experience with Salesforce DevOps tools (Gearset, Copado, Jenkins) for release management. Understanding of HIPAA, GDPR, Sunshine Act, FDA regulations, and data security best practices. Experience working in a global offshore-onshore collaboration model using Agile methodologies. Salesforce Platform Developer I & II certifications required. Excellent problem-solving and communication skills in a remote, global team setup. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Posted 1 week ago
6.0 - 8.0 years
8 - 12 Lacs
Hyderabad
Work from Office
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com . Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azuritys success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief team/department description: The analytical team in Azurity Pharmaceutical is responsible for support of formulation development and related analytical activities for various formulations intended primarily for US market. Principle Responsibilities: Minimum 6 to 8 Years working experience in analytical research and development lab with hands on experience of Method development, Stability analysis in Solid Oral (tablets, Capsules), Oral suspension and Oral solution. Hands on experience on at least HPLC/ UPLC, GC, UV, IR, pH meter, Dissolution, KF titrator etc. Should have potential exposure on method validation/method transfer of different analytical test methods. Good understanding of GLP, GDP, Data integrity and Documentation practices in lab work. Preparation of SOP, Test methods, Validation/Transfer protocols and reports knowledge is added advantage. Good knowledge and exposure on Related test and impurity profile methods development is needed. Knowledge about regulatory requirements on analytical methods, characterization of standards, and impurities is needed. Experience in calibration of different instruments like HPLC, GC, UV, IR, pH meter, Dissolution, KF titrator is required. Qualifications and Education Requirements M.Sc. Chemistry/ Analytical sciences or M. Pharmacy (Chemistry, Analysis or Pharmaceutics By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Posted 1 week ago
1.0 years
5 - 8 Lacs
Mahbubnagar
On-site
We require a gynaecologist in a specialty hospital like Eraya fertility, located at film Nagar Road Number 4, Hyderabad, plays a crucial role in women's health care. responsibilities include the following: 1. Routine Women's Health Care Preventive Care: Conducting regular check-ups, Pap smears, breast exams, and pelvic exams to detect early signs of gynaecological diseases. 2. Diagnosis and Treatment of Gynaecological Conditions Reproductive Health Issues: Treating conditions like fibroids, endometriosis, ovarian cysts, and sexual organ related infections (STIs). Menstrual Disorders: Managing issues related to irregular or painful periods, heavy bleeding, and other menstrual cycle abnormalities. 3.Fertility Treatments: Assisting with fertility issues through procedures like in vitro fertilization (IVF), egg retrieval, or hormone therapy. 4. Collaborating with Other Specialties Endocrinology: For managing conditions like diabetes or thyroid disorders in pregnancy. Oncology: For diagnosing and treating gynecological cancers such as ovarian, cervical, or uterine cancers. Urology: In cases involving pelvic floor disorders or urinary incontinence in women. 6. Education and Counseling Patient Education: Informing women about sexual health, menopause, and reproductive health. Counseling: Offering emotional support for issues like infertility, miscarriage, genetic counselling Overall, we expect gynaecologist at Eraya Fertility to ensure comprehensive care for women throughout different stages of their lives, working in tandem with other specialists for holistic patient management. Job Type: Full-time Pay: ₹45,646.08 - ₹70,000 per month Benefits: Paid sick time Schedule: Day shift Rotational shift Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: Jubilee Hills Job Types: Full-time, Permanent Pay: ₹45,000.00 - ₹70,000.00 per month Benefits: Flexible schedule Leave encashment Paid time off Schedule: Day shift Supplemental Pay: Overtime pay Performance bonus Shift allowance Education: Bachelor's (Required) Experience: Physician: 1 year (Preferred) total work: 1 year (Preferred) Work Location: In person
Posted 1 week ago
8.0 - 16.0 years
25 - 30 Lacs
Mumbai
Work from Office
Specialist Regulatory Affairs LCM - Strategic Growth Products Date: 14 Jul 2025 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma Location: Andheri, Mumbai (Hybrid working opportunity) About ADVANZ PHARMA ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About Business Unit The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. What You ll Do: Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Renewal Application and Annual Maintenance Variation Application Notification of Change in Marketing Status, sunset clause exemptions where applicable Notification of drug shortages Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Orphan Designation Maintenance (where applicable) Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Innovative Medicines (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through MA will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Formal training in Regulatory Knowledge, Skills Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Medical writing and Review experience Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines post approval changes such as PIP modifications and label expansions. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. Why ADVANZ PHARMA The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you ll be empowered to own your work, explore new possibilities, and make things happen. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.
Posted 1 week ago
8.0 - 16.0 years
25 - 30 Lacs
Mumbai
Work from Office
Select with space bar to view the full contents of the job information. Specialist Regulatory Affairs LCM - Strategic Growth Products Job Details | AdvanzPharma We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Specialist Regulatory Affairs LCM - Strategic Growth Products ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM for Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. Strategic Growth Products will include Innovative Medicines (NCEs or Biologics), Biosimilars and Specialty Generics that would require significant technical inputs on CMC and Clinical side during post approval phase. Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Notification of Change in Marketing Status, sunset clause exemptions where applicable Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Biosimilars (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through M&A will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Knowledge, Skills & Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Proven Biosimilars regulatory experience for EU preferably Life cycle activities. Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines or/and complex CMC post approval changes. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset & Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. *Please include a CV and Cover letter. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. Provider Description Enabled We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data centre "JSESSIONID" is placed on the visitors device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another
Posted 1 week ago
6.0 - 8.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description The analytical team in Azurity Pharmaceutical is responsible for support of formulation development and related analytical activities for various formulations intended primarily for US market. Principle Responsibilities Minimum 6 to 8 Years working experience in analytical research and development lab with hands on experience of Method development, Stability analysis in Solid Oral (tablets, Capsules), Oral suspension and Oral solution. Hands on experience on at least HPLC/ UPLC, GC, UV, IR, pH meter, Dissolution, KF titrator etc. Should have potential exposure on method validation/method transfer of different analytical test methods. Good understanding of GLP, GDP, Data integrity and Documentation practices in lab work. Preparation of SOP, Test methods, Validation/Transfer protocols and reports knowledge is added advantage. Good knowledge and exposure on Related test and impurity profile methods development is needed. Knowledge about regulatory requirements on analytical methods, characterization of standards, and impurities is needed. Experience in calibration of different instruments like HPLC, GC, UV, IR, pH meter, Dissolution, KF titrator is required. Qualifications And Education Requirements M.Sc. Chemistry/ Analytical sciences or M. Pharmacy (Chemistry, Analysis or Pharmaceutics By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Posted 1 week ago
0.0 - 4.0 years
35 - 50 Lacs
Kozhikode
Work from Office
MBBS + MD / DNB / DM endocrinology / full time Fellowship in endocrinology Locations: Kozhikode (Kerala) for renowned of diabetes treatment clinics Salary: as per standards Send your CV: find.healthcare.job@gmail.com Required Candidate profile for Kozhikode: sound know & experience in Endocrinology preferred THESE JOB OPPORTUNITY IS NOT ONLINE
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
pune, maharashtra
On-site
As a Data Review Associate at our rapidly growing corporate activities, you will be based in Pune and join our Global Clinical Coding & Support team. You will play a crucial role in accomplishing tasks and projects that are vital to the company's success. This is an exciting opportunity for you to utilize your previous nursing expertise and further develop your career. Your responsibilities will include conducting comprehensive manual reviews of clinical data collected in trials, developing clinical review guidelines for specific therapeutic areas, and collaborating with the Data Management team to ensure query resolution. You will specialize in therapeutic areas such as Oncology, Hematology, Infectious Disease, Endocrinology, and Metabolic disorders. To qualify for this role, you should hold a Bachelor's Degree in Nursing/Medicine or a more advanced clinical degree. Professional/Post-Qualification Nursing experience, preferably in Oncology and Hematology, is preferred. You should also possess general knowledge of clinical trial processes and/or experience working with clinical data. Experience with using MedDRA and WHO Drug dictionaries will be considered a plus. Medpace is a full-service clinical contract research organization (CRO) dedicated to providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. We are committed to accelerating the global development of safe and effective medical therapeutics through our scientific and disciplined approach. With headquarters in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries. Joining Medpace means being part of a team that has positively impacted the lives of countless patients and families facing various diseases. You will contribute to improving the lives of individuals living with illness and disease in the future. As a Medpace employee, you will enjoy a flexible work environment, competitive compensation and benefits package, competitive PTO packages, structured career paths with opportunities for professional growth, company-sponsored employee appreciation events, and employee health and wellness initiatives. Medpace has been recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024. We have also received CRO Leadership Awards from Life Science Leader magazine for our expertise, quality, capabilities, reliability, and compatibility. If you are interested in this opportunity, a Medpace team member will review your qualifications and reach out to you with details on the next steps. Join us at Medpace and make a difference tomorrow!,
Posted 1 week ago
0.0 - 4.0 years
0 Lacs
delhi
On-site
We are searching for a MD Physician to join our team at Our Multispeciality Hospital in West Delhi. As a MD Physician, you will be responsible for providing comprehensive healthcare services in our leading hospital with 80 beds. The hospital is equipped with advanced levels of care in various specialties including Anesthesiology, Cardiology, Dentistry, Dermatology, ENT, General Medicine, General Surgery, Gynecology and Obstetrics, Neurology, Urology, Orthopedics, Pediatrics, and Endocrinology. The working hours for this position are from 9:00AM to 6:00PM. Our Multispeciality Hospital is dedicated to delivering the best healthcare services with a team of skilled professionals. Located in West Delhi, we are committed to providing exceptional medical care to our patients.,
Posted 1 week ago
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