Responsibilities Develop and write high-quality scientific manuscripts, abstracts, and presentations. Ensure all publications are in compliance with industry standards and regulations. Collaborate with research teams to understand study objectives and results. Translate complex scientific data into clear, concise, and engaging content for various audiences. Stay updated on the latest trends and developments in biomedical sciences.     Qualification & Experience Advanced degree (MDS or PhD) in Life Sciences, Biomedical Sciences, or a related field. Certified Medical Publication Professional (CMPP) certification is mandatory. Proven experience in manuscript and publication writing within the biomedical sciences sector with at least two years of experience in industry manuscript writing. Strong understanding of the publication process and ethical guidelines in scientific research. Exceptional writing, editing, and communication skills. Ability to work independently and manage projects with minimal supervision.     Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Roles and Responsiblities Prospect and identify customer cohorts for targeted engagement. Collaborate with cross-functional teams to establish the Obesity Clinic Program, improving managed care settings for obesity across India. Build partnerships and collaborations with healthcare professionals in private, corporate, and aesthetic centers, as well as nutritionists, to enhance obesity care. Lead and implement patient awareness initiatives, such as camps and HCP-PwO interactions, to raise awareness about obesity as a chronic disease.   Qualifications Life Sciences, Science graduate or equivalent. Bachelors/Diploma in Nutrition / Hospital management. Desired Business administration. 5 -8 years of field experience in Launch sales responsibility, Market/therapy shaping pre-launch. Partnership establishment and continued development. Development of Centre of Excellence/On-ground activation.  

Roles and Responsiblities   Developing an understanding of regulations, guidelines, procedures and policies. relating to registration and manufacturing of pharmaceutical products. With management oversight, ensuring data and information packages are fit for purpose. Beginning to understand internal/external CMC Regulatory environment. Begin to build organisational networks. Regular communication with line manager to help identify any CMC issues with business impact. Conducts routine Rx and/or Vx CMC projects with support

Responsibilities Monitoring of IPQA activities Granulation, Compression, Coating, Capsule Filling, soft gel manufacturing, primary and Secondary Packaging Area. Monitoring Exhibit and Validation batches. Preparation and review of process validation and Hold time protocols and reports. Handling of Quality Notifications like Deviations, Change Controls, and its related Documents. Reviews and Approval of CAPA includes tracking, follow-up, reporting/trending and evaluating CAPA and action plan for effectiveness. Review of APQR (Annual Product Quality Review) based on the outcome CAPA shall be initiated. Ensure performance of self-Inspection/ Internal audits (Internal, External, Customer, Visits, and Regulatory) and assist with external quality system audits. Providing response for Manufacturing related regulatory audit observations.   Qualification & Experience 12-15 years in Quality Assurance specifically in IPQA   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities  Independently and confidently executes agreed dossier strategy. Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected. Independently completes data assessment to ensure dossier is fit for purpose. Identifies risks associated with submission data and information packages. Escalates issues with line manager that have business impact. May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems. Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff. Understands internal/external Regulatory environment. Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing. Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.   Qualification & Experience Minimum 6-10 years of experience Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines  

Responsibilities Champion cutting-edge innovative technology solutions for document creation that add value in terms of cost, quality and time. Oversee planning, execution and monitoring of technology implementation. Ensure assigned project deliverables are met on time. Collaborate with medical writing SMEs, functional stakeholders and experts to ensure solutions meets highest quality medical and compliance standards and ensure all digital medical content complies with industry regulations, such as FDA guidelines. Establish and maintain relationships with technology vendors to ensure smooth delivery of products and services with highest quality and timeliness. Act as Technology ambassador assisting users on training/onboarding, ensuring that they can leverage solutions effectively. Lead and assist in development of new SOP’s and learning modules for technology implementation. Propose enhancements, Identify gaps and provide/collect feedback for continuous Product improvement. System validation Provide insights to help reimagine Medical Writing role/responsibilities by contribute to innovation strategies for the Medical Writing team  

Responsibilities P & L Management Service Experience Management Operational Efficiency Clinician Engagement Quality and Clinical Governance People Management & Stakeholder Alignment Business Development   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities You will be responsible for managing the timely preparation and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout their lifecycle. This includes marketing authorisation applications and all post-approval activities. You will also be accountable for delivering “submission ready” international CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures.     Qualification & Experience Bachelors degree in Science, Regulatory Sciences or Pharmacy Experience in Regulatory / Drug development (Industry or Health Authority) Breadth of knowledge of manufacturing, project, technical and regulatory management.  

Responsibilities Develops strategic studies with the end-customer in mind to ensure that the results will favorably impact pricing, reimbursement, and market access as well as market uptake. Lead development of reimbursement strategy for key products, value proposition and all supporting data/messages to accelerate market access. Deployment of HEOR (Health Economics & Outcome Research) tools in line with business priorities, in collaboration with country marketing team Facilitate high-level government visits and activities in close cooperation with other teams within Alcon. Monitoring, analyzing, and reporting on government policy and legislation (e.g., identifying emerging policy/regulatory trends, developing issues and position papers for presentation to business leadership, etc.) Serve as Alcon India’s expert on reimbursement in the Insurance sector, both government and private. Work collectively with insurers/ payers, reimbursement influencers and other decision makers to ensure commensurate reimbursement for innovative medical technologies, especially for premium eye care treatments. Communicates the unique attributes of the therapeutic area drugs/medical devices to external multi-stakeholders to ensure the drug's/device's value proposition will be recognized and maximize market uptake. Coordinate the implementation of market access strategy in collaboration with sales, marketing, and GA&MA teams. Propose solutions for surgery capacity building and product offerings by putting agreements in place on preferred partnerships and contracts. Provide insightful recommendations to management team for decision making based on payer and customer feedback to optimize profitability and access. Organize regular policy communication/training, internal newsletters and best practice relating to reimbursement, and market access with local GA and sales team. Engagement and collaboration with global market access team. Align with regional, global, and business team on development of overall Government Affairs & market access strategy and integrate resources to support business growth. Lead and execute, in collaboration with relevant stakeholders, Alcon India’s CSR initiatives.   Qualification & Experience Bachelor’s degree must Post-graduation degree in Pharmacy, Economics or Medical Related Sciences preferred. Broad knowledge of Surgical and Medical Industry and Market Access & Government Relations. At least 10 to 12 years of overall experience and 5 years of experience within Government Affairs/Market Access in medical device or pharma industry  

Responsibilities Ensure regulatory compliance of the company and product at all times: Recording country speci?c regulatory submissions by compiling submissions in a format consistent with applicable U.S. FDA guidance documents, technical writing, and analysis to support implementing quality assurance procedures for compliance, documenting device requirement speci?cations and planning and leading ISO 13485:2016 audits. Bringing the product to market through regulatory clearance (U.S. FDA): Work across all teams by giving strategic and regulatory advice and support, making important contributions commercially, technically, and scienti?cally to the success of the product’s commercialization. Documentation of current regulations: Have a close eye on changes in medical regulations and immediately document the relevant change in device regulations, additionally collect, collate, and evaluate scienti?c data. Document management: Maintain and update all the quality assurance and regulatory documentation, wherever and whenever necessary. Should work on managing and documenting information, and must be adept at working with databases and other information management tools. Interaction with regulatory bodies: Assist in preparing responses to regulatory authorities within assigned timelines to stay abreast of regulatory procedures and changes in the regulatory climate. Device comparable research: Develop strategies to search for comparable devices in the market of interest for commercialization. Build case studies and arguments: Should be able to infer from the regulations and build use cases, and arguments for the device under consideration.