Responsibilities Medical Records Review: The candidate shall examine patient medical records, including admission notes, progress notes, treatment plans, diagnostic test results, and discharge summaries. They assess the accuracy and completeness of documentation and ensure compliance with regulatory standards and organizational policies. Assessing Care Quality: The candidate shall evaluate the quality of care delivered to patients by assessing adherence to clinical guidelines, standards of practice, and evidence-based protocols. They identify any deviations from best practices or instances of suboptimal care and recommend corrective actions as needed. Appropriateness Review: The candidate shall conduct reviews to assess the appropriateness and necessity of medical services, procedures, treatments, and hospital admissions. They determine whether healthcare resources are utilized efficiently and whether the level of care provided aligns with established clinical criteria and guidelines. Medical Necessity Review: The candidate shall perform medical necessity reviews to determine the necessity and justification for specific medical services or procedures. They evaluate clinical documentation, review relevant clinical criteria, and make informed decisions regarding coverage and reimbursement based on established guidelines and policies. Quality Improvement Initiatives: The candidate shall participate in quality improvement initiatives aimed at enhancing patient care outcomes and improving operational efficiency. They collect and analyze data, identify trends and patterns, and recommend process improvements and performance enhancements based on evidence-based practices and benchmarks. Provider Education and Collaboration: The candidate shall collaborate with healthcare providers including physicians, nurses, and allied health professionals, to facilitate communication, address clinical concerns, and promote best practices in care delivery. Reporting and Documentation: The candidate shall maintain accurate and detailed documentation of review findings, decisions, and recommendations using electronic health record (EHR) systems.     Qualification & Experience Bachelor's degree in Nursing or any medical-allied field. Proven experience of at least Minimum 10+ years of experience working as a Clinical documentation reviewer in US Healthcare industry or a Minimum 4 years’ experience in US Healthcare with Nursing background.  

Responsibilities The role will play a critical role leading the operational strategies and objectives in a cross-functional manner. Research, analyze, validate, and document effectiveness of current operations, processes and develop strategy goal to impact both operational, clinical, and financial metrics. This role will identify areas of operational development and performance improvement related to functions such as: referral management, scheduling, call center activities, integrated clinical and operational activities, and other infrastructure required for business optimization. Responsibilities include: Develop and implement related strategies to ensure positive profitability, productivity and efficiency throughout the company’s operations including Woundtech’s US and India-based Clinician Support departments (Patient Care Coordination, Care Monitoring, Intake), Puerto Rico Operations and Facilities Management. Partner with multiple stakeholders and leadership to establish strategic visions, operational objectives, and processes ensuring compliance with state contracts, related laws, regulations, and organizational goals. Oversight to ensure day-to-day operations are effective and adherent to processes. Utilize data analytics to manage productivity, gaps for improvement, training opportunities, changes in processes, and opportunities to collaborate across the organization. Develops an organization and management support team to enable the company to meet or exceed the service level requirement of both internal and external customers. Design team structure and align appropriate levels of personnel to maximize output and efficiency. Identify process improvement opportunities and assist in development and implementation of the solutions. Develop and implementation of organization dashboards, analytics, and root cause reporting for the responsible functions and across the organization as applicable. Identify opportunities for automation, analytics, and standard operating procedures to support program production, quality, and financial targets. Assist in streamlining and standardizing training for related operations functions. Develop and manage a quality integrity program ensure adherence of workflows, documentation requirements, turnaround times, and other related functions and incorporate into the performance management of team members. Collaborates with various levels of team members across the organization to improve operational effectiveness. Interact regularly with the leadership team and individual department heads to ensure that company’s operational priorities are aligned with organizational goals. Lead operational review meetings to review metrics, goals, gaps in goal, trending patterns, root cause analysis, etc. Lead organization wide projects including, development of timeline, project milestones, facilitating workgroups, setting annual departmental goals. Coordinate in a matrixed reporting structure to complete job functions.     Experience 5+ years’ experience in healthcare operational setting or role Strong analytical skills to assess data, make informed decisions, and develop effective plans both at the patient and operational design level.  

Responsibilities The Medical Sales Representative will be responsible for promoting and selling our services to paediatric healthcare professionals, and paediatricians. The role involves building and maintaining relationships with clients, providing product information and support, conducting sales visits, and managing sales targets.   Qualification & Experience Medical Sales and Customer Service skills Strong communication and interpersonal skills Has an existing network of doctors and paediatricians Experience in sales or marketing in the healthcare industry Excellent presentation and negotiation skills  

Responsibilities Detailed Knowledge of regulatory processes in key regions such as India , SEA,LATEM,EU, China, USA for food and food supplements including herbals. Knowledge in working/ representing scientific regulatory issues at regulatory forums in India and global level Knowledge of the broader market understanding and competitor landscape in the space especially infant, pediatric, adult and hospital nutrition segment, food supplements and OTC products. Knowledge of dossier development, and leading project management of regulatory dossiers across multiple markets Leading the cross functional alignment for successful delivery of dossiers across markets including regulatory publishing management Leading regulatory discussions and enabling local country teams with efficient process management while keeping business targets on time. Ability to manage and lead RA-QA interface for India & other markets Ability to integrate the local nuances at design , deploy and maintenance stage of various dossiers across markets Knowledge of the various nuances of the Food & Nutrition Consumer Industry & Market Trends and its application to regulatory strategy and compliance include categorization very clear understanding and interpretation of regulatory laws and guidance including update both and India and US/ EU level   Qualification & Experience Bachelor’s or Master’s Degree Minimum work experience: 10+ years Experience of the complete nutrition and nutraceutical market along-with additional knowledge of Understanding of Food Supplements and their relationship to Human Physiology/ Health/ Diseases Experience in Identifying & Evaluating the new product regulatory strategy during the ideation stage to minimize risks during the product development cycle.  

Responsibilities To dispense drugs / medicines as per requirement / prescriptions. To review prescriptions (in print / online requisitions) to assure accuracy, to ascertain the needed ingredients and to evaluate their suitability. To check stock availability. Arranging medicines as per storage conditions. To provide information and advice regarding drug dosage. To identify expired / near expiry / damaged drugs and prepare a monthly report on expired / near expiry / damaged drugs. To maintain and update records. Indent to Central Stores for non availability of stock. Take a printout of ‘A’ grade items and physically verifying the same. Maintain and control Narcotic drugs as per act and keep a record to it. Hand over cash to cashier.     Qualification & Experience B.Pharmacy / D.Pharmacy Minimum of 2 years in a Hospital OP Pharmacy as a Pharmacist. Freshers too will be considered for this position if they have PCI certificate.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Understands regulations, follows complex directions, and investigates regulations when clarification is needed. Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to: registration, labeling, and post-market surveillance requirements. In alignment with applicable strategies/plans and with support of team members, determines appropriate documentation and testing required for registration of products and coordinates with functional team members to obtain and provide this information. Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory agencies. Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications). Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labeling and advertisement/promotional material to assure regulatory compliance. Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes and helps determine impact and/or appropriate action. Assures regulatory compliance and content accuracy of technical documentation and submissions. Hands on EU-MDR, 510K, ISO14971:2019, RA Files, IFU, Regulatory submissions Develops an expertise of the medical device regulations for assigned products. Determines applicable strategies /plans for products and works with functional and cross-functional team members to create, obtain, and provide this information. Provides regulatory perspective and expertise to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations. Reports relevant regulation and standards changes, determines impact and takes appropriate action. Ensures regulatory compliance of products and processes through participation in process updates. Bio-compatibility knowledge with Standard: 10993-1:2023,Sample Rationalization/Equivalency, Bio comp Evaluation Plan, Chemical Characterization , Biological safety of device End OF Life Evaluation, Gap assessment with latest standard Supports internal and external (third party) audits as required.   Qualification & Experience Bachelor of Science in science and/or engineering field 8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered) Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards. Experience in Orthopedics industry preferred.  

Qualification & Experience MBBS 1 to 5 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Responsible for project management support to the scientific writer ensuring the end-to-end effective project delivery of the designated publication/medical education deliverable across all phases. Initiate and amend submission based on comments (as required). Support the writer with internal and external stakeholder communication. Track the delivery of activities (including managing issues and risks) and support follow up. Support required submission, compliance/ approval activities, and ensure compliance with publication processes and end-to-end publication management tools (e.g., iEnvision - previously, Datavision/Matrix) and update as required with approval/compliance tools (e.g., PromoMats, DAM). Support the management of the assigned publication or medical education in line with the agreed budget. Support and manage as required external spend tracking (e.g., approvals, purchase orders, and goods received). Support adherence to associated compliance related activities and approvals (with internal stakeholder taking accountability for compliance). Collaborate effectively with stakeholders: Scientific communication global and/or local teams; and medical content enhancement teams.     Qualification & Experience Experience: 3-5 years post qualification experience Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills: Project management; Scientific/Medical writing/communications; Pharma experience (including but not limited to therapeutic area/domain knowledge exposure; and/or publication submission) Education: University degree level (Graduate degree, preferably in science). Additionally, relevant advanced/postgraduate degree in life sciences/pharmacy/similar discipline desirable  

Responsibilities Carry out Analytical method development and pre-validation involved in assigned projects, protocols & reports, in compliance with Ferring QMS to achieve the objectives as per project requirements. Carry Out Author and review Analytical documents, not limited to method development reports, justification reports etc., to be built on strong scientific rationale, study designs & compliance with ICH, compendial & regulatory guidelines. Carry out & Ensure Analytical deliverables for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements. Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements. Carry out Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements. Carry out & Ensure Managing stability study related activities for assigned projects to achieve the objectives as per project requirements. Ensure Outside analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements. Carry out Literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements. Carry out Review of ELN experiments, Data, Reports and documents generated within lab & those received from CRO/CMO in line with defined quality standards. Support Procurement activities related to project & laboratory i.e. vendor contact, URS, SOW etc. in line with defined quality standards. Support Coordinating with Facility/Vendor for instruments and equipment AM, PM and regular maintenance in Analytical lab in line with defined quality standard.     Qualification & Experience Ph.D (preferred), M. Pharma/M.Sc in Pharma Chemistry from reputed University. Experience: M. Pharma/M.Sc in Pharma Chemistry with around 11-14 years of experience or PhD in Pharmaceutical Chemistry/Analytical Chemistry with 6-8 years of experience in analytical development for formulations.  

Responsibilities Responsible for RSL, R&D, VER, Biologics and Synthetic Labs of USP India site for Columns, Equipment spares, consumables, and chemicals Inventory management. To coordinate with all the Labs and submit item code requests to Stores. To coordinate with the Labs and create PR and Move orders for the inventory such as General items, chemicals, and columns in ERP. Responsible to collect the columns/chemicals from Stores as per the move order and to arrange in respective Labs at designated storage areas. Responsible to update the transactions in APEX application for the chemicals and columns To handle the expired chemicals in the Labs and ensure to submit monthly to Stores for disposal. Responsible to issue the columns as per the Labs requirement and receive the columns To perform the physical verification quarterly against the on-hand report for the chemicals and columns To support Central Lab operations in issuance of consumables / spares to the Labs. To take up the additional responsibilities assigned by the supervisor.     Qualification & Experience BSc. Chemistry with 0-1year experience in a reputed Pharmaceutical company. Knowledge on ERP / SAP application will be an added advantage Knowledge on Laboratory compliance (GMP and GLP).