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.

Responsibilities Clinical Requirement Gathering: Attend clinical meetings and interact with clinicians to understand and gather their clinical requirements for product development. Ensuring Clinical Quality: Review data provided by Clinical Data Engineering and AI Research Teams at all stages of product development for clinical accuracy. Ensure the final product meets the precise clinical requirements. Provide clinical strategy: Understand clinical aspects, design and development of AI technologies, and principles of medical device development to provide a clinical strategy to help in technology and product development. Ensuring clinical competency of internal teams: Research, interpret, and summarize published medical/scientific literature/clinical guidelines. Prepare internal training materials, documentation, protocols, and SOPs to ensure the clinical competency of teams involved at various stages of product development.     Qualification & Experience B.E or B.Tech in Biomedical Engineering / Biotechnology / B.Sc in biological sciences 2 to 3 years of experience in an ultrasound application specialist role demonstrating expertise in ultrasound machine handling and radiology applications. Ability to read, understand, and interpret ultrasound data, including images, video loops, and reports.  

Responsibilities Ensuring clinical quality and integrity of medical data: Support in preparation of medical image annotation for training and validation of AI algorithms Review medical data provided by Clinical Data Engineering and AI Research Teams at all stages of product development for clinical accuracy. Ensure the final product meets the precise clinical requirements. Provide clinical strategy: Understand clinical aspects, the design and development of AI technologies, and the principles of medical device development to provide a clinical strategy to help in technology and product development. Provide clinical strategy: Understand clinical aspects, the design and development of AI technologies, and the principles of medical device development to provide a clinical strategy to help in technology and product development.   Qualification & Experience Bachelor of Medicine and Bachelor of Surgery (MBBS) Degree with DNB/MD in Obstetrics/Gynaecology OR Radiology At least 2-5 years of experience with Fetal Imaging Data-driven with the ability to analyze and extract clinical insights to support decision-making.  

Responsibilities Develop, implement and maintain policies, local procedures and tools to achieve a consisitent risk based approach to computer system validation and Administration of Quality and R& D systems. Develop and implement 21 CFR Part 11 and any other related regulatory compliance strategy for new and existing systems, including remediation of legacy systems. Represent the regulatory inspections with respect to computer system validation, GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions. Participate as an Subject Matter Expert for computerized system validation and IT Compliance. Participate in projects,investigations, audits and improvement initiatives. Devise strategies and Lead CSVC and GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions. Setup operation processes for sustaining compliance and service delivery of GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions. Collaboration with Global CSVC and IS teams to harmonize CSVC and IS policies,procedures, processes across Apotex. Monitor, audit and assess department performance vs business objectives to implement improvements, determine continued relevance and anticipate opportunities. Ensure adherence of team members with all compliance programs and company policies and procedures. Ensure the computerized system validations and documentation as per GDP and QMS. Ensure Site & Global SOP’s shall be followed during Computer system validations and Administration GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions compliance as applicable. Review and Approve of documents in GIS. Follow QMS process in trackwise as per applicable SOP. Predictive compliance activities like review of regulatory guidance’s, regulatory observations etc. Maintain effective inter-personal relationship with Cross-functional department personnel. Work as Team member to achieve Goals and objectives of department. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion. Performs all work in accordance with all established regulatory and compliance and safety requirements. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance program, Global Quality policies and procedures,Safety and Environment policies and HR policies. All other duties as assigned by Superior.     Qualification & Experience A minimum university graduate in BE/ B. Pharm / M Pharm / M. Sc. Knowledge, Skills and Abilities Knowledge on CSV, Quality and R& D systemss, 21 CFR Part 11 and EU Annex 11. Knowledge on ICH Q7, GMP, and GAMP guidelines. Team work and collaborative skills. Proficient in verbal & written communication skills. Minimum 12 years of experience in GMP regulated Pharmaceutical Industry. Minimum 8 years of experience in people management.  

Responsibilities Execute Lilly business requirements for the study/program for vendors to deliver clinical trial data Ensure that data management deliverables are delivered to scope, cost, and time objectives Coordinate end-to-end data management activities – from study set up through trial execution through dataset delivery, including on time delivery of a quality, locked database Ensure flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker) Contribute to key deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets) Participate in submission, inspection and regulatory response activities Central coding activities completed Archiving and decommissioning of study related data management documents and content Ensure that data acquisition, database design, data validation, data review, central coding and observed dataset requirements are reflective of specific protocol objectives Adhere to standards decisions, implementation and compliance for the study/program Track and report out key study build, execution and data deliverable metrics Help create scope scenarios and negotiate outcomes with study teams while considering the cost and value Facilitate the integration of disparate data sources into datasets for decision making Utilize therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables Continually seek and implement means of improving processes to reduce cycle time and decrease work effort Represent Data and Analytics processes in cross-functional initiatives Actively participate in shared learning across Data and Analytics organization   Qualification & Experience Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy