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About the Position Job Description Global Medical Centre of Excellence Patient Value&Innovation At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization in developed and emerging markets. We are seeking a Therapy area Lead at our office in Bangalore, within the Global medical COE organization. Reporting to the Medical Head, the person will be responsible for Global KOL management, internal medical guidance and approval, executing medical affairs strategy, and creating effective medical education and engagement programs. In addition, the candidate will help to establish patient advocacy with patient communities and champion the patient perspective within the company. The right candidate will be an excellent communicator with an ability to develop meaningful relationships, a strategic thinker that can bridge the complexities of patient care and drug development and access, a collaborator who can successfully lead and influence external and internal stakeholders, and a highly motivated self-starter who is comfortable innovating in an entrepreneurial and fast-paced company environment. Responsibilities Build a network of global key opinion leaders through enhanced scientific interfaces and best practices Help create and drive a global medical strategy and communication plan for the therapy area Engage and build robust relationships with HCPs, and KOLs on value, access, and pharmaco-economic areas, also seek advice on unmet needs for patients and other stakeholders Develop/validate appropriate scientific content for conferences, briefing meetings&other policy-related activities/initiatives Assist in the planning of new global campaigns and launch activities Be a brand ambassador for Biocon Biologics and its products Safeguard patient benefit always through the application of relevant knowledge of science, regulations, and compliance in all initiatives undertaken by the organization Author publications/blogs/white papers related to the value and differentiation of our products Promote patient centricity within Biocon Biologics Provide valid scientific responses to all the medical queries from the customers regarding the products and therapy area involved Promote diversity&inclusion in clinical trials, and data and get involved in ESG objectives as it pertains to medical affairs Together with the global clinical development team, formulate meaningful real-world evidence studies, and support clinical strategy and execution related to registration and post-registration clinical trials. Other basic requirements include: Ability to interact with senior internal and external personnel Attention to detail and taking accountability Ability to work across more than a few therapy areas Ability to work across geographies in a global role Create sense of purpose and inspiration in the team Must be able to work in a team environment, working closely with cross-functional teams Collaborate with medical affairs colleagues in other countries/regions and share knowledge and learnings Functional expertise in MS office, Veeva Vault Substantial knowledge and understanding of policies, procedures, and guidelines relevant to medical affairs operations Substantial knowledge of HCP policies and regulations Proven understanding of the needs of individuals living with cancer and chronic diseases like diabetes or other autoimmune diseases as well as pressing public health issues, including at the pharmacy and HCP levels. Qualifications Bachelor's degree required; advanced degree preferred (e.g., MS, Ph.D., or MD); Minimum 05 years of medical affairs, patient access, and advocacy experience in the biopharmaceutical, or relevant non-profit or payer industry. Must be willing and able to travel (approximately 25-30%). no -- Principals only. Recruiters, please don’t contact this job advertiser. no -- Please, no phone calls about this job! no -- Reposting this message elsewhere is NOT OK.
About the Position Why join Stryker? We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.Know someone at Stryker? Be sure to have them submit you as a referrral prior to applying for this position. Learn more about our employee referral program Who we want Analytica l - Synthesizes complex or diverse information; Collects and researches data; uses intuition and experience to complement data; designs workflows and procedures.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in both group and as an individual Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.Communication– Develops a working relationship with the key stakeholders to ensure alignment must work well in a team environment Self-motivated – Effectively commits self to achieving and takes advantage of opportunities Position Summary: As a Principal Medical Affairs Specialist, you will ensuresuccessful preparation of high quality submission-ready clinical documentation related to clinical submissions. Your primary role involves translating complex scientific and technical information into accessible content for various audiences. You will work closely with cross-functional teams (Marketing, Research and Development, Regulatory, and Quality), ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, and Summary of Safety and Clinical Performance.The Principal Medical Affairs Specialist will report to the Spine CQR Manager and will work directly with divisional counterparts in Regulatory, PMS and medical affairs group. The role will support Post Market efforts related to CERs, PMCF documents, and SSCPs. In this critical role you will have the ability to influence and evolve our product security needs at the product and program levels.What you will do Recruit, onboard, train and manage talent for building organizational capabilities. Manage deliverables (protocols, reports, literature searches, succinctly summarizing scientific content) and metrics with efficient planning, scheduling and resource allocations. Author clinical trial protocols, interim and final clinical study reports, integrated safety/performance data summaries from raw data as applicable.Perform formal literature searches, and succinctly summarize scientific content for assigned projects. Interprets literature information and synthesizes the information in clinical regulatory documents. Provide clinical science subject matter expertise and consultation to clinical research associates, biostatistics, data management, regulatory affairs, medical Safety and other internal and external stakeholders.Compiles clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates.What you need: A minimum of a bachelor’s degree (BA or BS) in a technical and/or scientific discipline required. Master’s or (RN, BSN, BPharm/MD/MPH) is required 8+ years of Industry experience in medical technology or pharma is required 6+ years of experience in Scientific or Medical Writing, relevant academic or clinicalresearch experience (Masters or PhD) is preferred.Expertise in interpreting information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams. Expert knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents required.Excellent scientific and medical writing skills required. Must be able to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document. Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research&Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses. Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred. Excellent knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/GCP/EU MDR/MDCG) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology.Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation required. Motivated, self-starter with the ability to work with minimal supervision, make independent decisions, technical aptitude, attentiveness to detail, and excellent communication skills. Good planning and organizational skills, with the ability to adapt and adjust to changing priorities.Strong communication, project management and influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization. Strong interpersonal skills, written, oral communication and negotiations skills. Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.Builds strong relationships by fostering open communication, respect and trust. Act with a customer service/stakeholder-focused approach. Leverages excellent interpersonal keys to achieve desired outcomes.. Qualifications&experience: Analytica l - Synthesizes complex or diverse information; Collects and researches data; uses intuition and experience to complement data; designs workflows and procedures. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in both group and as an individualTechnical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Communication– Develops a working relationship with the key stakeholders to ensure alignment must work well in a team environmentSelf-motivated– Effectively commits self to achieving and takes advantage of opportunities Physical&mental requirements: Must be able to effectively manage multiple conflicting priorities in fast-paced environment. Must be able to learn and absorb product knowledge quickly and efficiently Must be able to communicate effectively via phone and email. Ability to operate common office equipment.About Stryker Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at no -- Principals only. Recruiters, please don’t contact this job advertiser. no -- Please, no phone calls about this job! no -- Reposting this message elsewhere is NOT OK.
About the Position To conduct pre-flight, post flight medical and ground staff checks and maintains all its documentation and records as per prevailing DGCA and company rules. - To maintain the upkeep of the Medical Centre and address all discrepancies. - Assist in replenishing and certifying the contents of the First Aid Kit, Medical Kit and Universal Precaution Kit. - Treat the employees and attend to the emergencies in the capacity as a paramedic. - Assist in dealing with the casualties of the accidents / medical incidents in the Airport areas for employees of IndiGo, if needed as a paramedic and administerfirst aid. - Coordinate with emergency services if necessary. - Assist and submit themselves to DGCA / internal audits and investigations, if required. - Respond to calls and airport accident drills conducted by Airport Operator or any other suitable authority. - Work in shifts as per company requirement. - Willingness to travel outside Delhi for audits / checks and other temporary functions, if required. - Maintaining administrative requirements of medical room like monthly stock taking for PFMC related stationery / eqpt, Medicine stock, stationery requirements and initiate process for purchase as and when necessary etc. - Assist medical officers in functioning / tasks of medical section. Maintain medical room as per DGCA requirements at all times. Be aware of and comply with his / her safety responsibilities and accountabilities as laid down in the IndiGo SMS Manual, Chapter Safety Policy and Objectives. 30+ days ago no -- Principals only. Recruiters, please don’t contact this job advertiser. no -- Please, no phone calls about this job! no -- Reposting this message elsewhere is NOT OK.
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