Responsibilities Prepares, reviews, and/or maintains a range of other QA documentation as required Authors and reviews new and existing SOPs to further enhance and mature the Quality System. Evaluate and enhance departmental and company and/or vendor site quality procedures to ensure compliance with ISO 13485:2106 Responsible for authoring and maintaining technical files for Europe as per EU MDR 2017/745 Provides consultation/advice to manufacturing organizations for change control and product development. Provides regulatory direction/interpretation Interprets and applies regulatory understanding to support products and teams Ensure compliance with product postmarketing requirements Assembling PMS data for review and analysis Writing PMS reports and Periodic Safety Update Reports (PSUR) Involvement in the writing of Summaries of Safety and Clinical Performance (SSCP) Familiarity with the European MDR (EU Medical Device Regulation 2017/745) Conduct internal audits, identify CAPAs, and oversee the effectiveness of CAPA implementation to maintain site quality compliance Have a great knowledge of ISO 13485 and Medical Device legislation, to provide support and advice to the organization. Trains clients and other staff on regulatory compliance requirements and quality management system requirements Search various vigilance databases for adverse events and recalls.   Qualification & Experience Highly experienced professional in Medical Device Regulations Has experience in reviewing and preparing all QMS documents Has experience in Internal as well as external audits Relevant education relating to MDR 2+ years of experience is mandatorily required in the QA area   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities The Biostatistician will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts); The Biostatistician will ensure SOPs are followed and timelines and quality metrics are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Closely follow QC plans and timelines set by senior members of the Sanofi Global Hub biostatistics and programming team.? 5) Review appropriate biomedical and clinical research literature related to assigned project(s). Customer: 1) Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables.     Qualification & Experience Experience: Master's degree with 3-6 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 2-3 years. Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry?, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills: Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education: Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology  

Responsibilities Maintain effective relationship with the end stakeholders within the allocated GBU and tasks – with an end objective to develop education and communication content as per requirement. Actively lead and develop SGH operations associates and ensure new technologies are leveraged. Initiate the contracting process and related documents within defined timelines; and Collaborate with global stakeholders for project planning and setting up the timelines and maintaining budget. Performance: Ensure data supplied by CDM is used effectively by stakeholders in commercial operations processes (forecasting targeting, call planning, alignments, field reporting, incentive compensation). Administer CDM activities related to the sales operations quarterly cycle. Monitor data quality reports and investigate problems. Maintain requirements documents, business rules and metadata. Provide first-level support for sales data inquiries. Provide ad-hoc support to CDM colleagues. Refresh Existing Reports and identifies improvement opportunities in reporting and BI tools and as needed structure / functionality with the latest insights as they become available. Create dashboards to synthesize and visualize key information and enable business decisions. Works to develop deal tracking analytics and reporting capabilities. Collaborates with Digital to enhance data access across various sources, develop tools, technology, and process to constantly improve quality and productivity. Process: Support delivery of projects in terms of resourcing, coordination, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical/ field writing group, including scientific documents and clinical/medical reports. Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical/ field writing group; and Secure adherence to compliance procedures and internal/operational risk controls in accordance with all applicable standards Refresh report on frequency/cycle basis (weekly/monthly/quarterly/annually), along with QC checks for each refresh. Stakeholder: Work closely with global teams and/ external vendors to ensure the end-to-end effective project delivery of the designated publication/medical education deliverables     Qualification & Experience 5+ years of experience in pharmaceutical product commercial omni channel datasets, data governance and data stewardship. In-depth knowledge of common databases like IQVIA, APLD, SFMC, Google analytics, Engagement and execution data, etc. Soft skills: Strong learning agility; Ability to manage ambiguous environments, and to adapt to changing needs of the business; Good interpersonal and communication skills; strong presentation skills a must; Team player who is curious, dynamic, result oriented and can work collaboratively; Ability to think strategically in an ambiguous environment; Ability to operate effectively in an international matrix environment, with ability to work across time zones; Demonstrated leadership and management in driving innovation and automation leveraging advanced statistical and analytical techniques. Bachelor’s degree from an accredited four-year college or university At least 5+ years direct experience with pharmaceutical sales data and data management with the emphasis on syndicated data, Specialty Pharmacy and digital/multi-channel data Strong technical background in AWS, Snowflake, Data Bricks, SQL, Python, Informatica etc  

Responsibilities People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Work closely with the Lead Biostatistician and Lead Programmer to develop and implement project QC plans and timelines.? 5) Review appropriate biomedical and clinical research literature related to assigned project(s). Customer: 1) Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables     Qualification & Experience Experience: Master's degree 6 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 3 years. Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines.  

Responsibilities The Regulatory Affairs team at GRACURE PHARMACEUTICALS LTD. is expanding, offering exciting opportunities for dynamic professionals. As an Executive/Manager in Regulatory Affairs, you will: Collaborate with R&D and stakeholders for timely filing and review of documents in EU, UK, CA, AUS for solid oral and topical dosage forms. Develop RA strategy in collaboration with partners with a focus on cost implications. Plan RA grids for extension projects and execute them in the plant. Innovate regulatory strategies, enabling flexibility in dossiers and proposing cost-saving ideas.   Qualification & Experience M Pharma Experience: 3 to 16 years   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities The Research Associate will be responsible for conducting chemical research, developing and optimizing synthetic routes, developing analytical methods and validate processes. The role also includes preparing and presenting research findings and collaborating with various teams in the company.   Qualification & Experience Experience in synthetic organic chemistry, including multi-step organic synthesis and process development Experience with analytical techniques such as HPLC, GC, LC-MS, NMR Experience in developing and validating analytical methods Strong problem-solving skills and attention to detail Excellent written and verbal communication skills Ability to work effectively independently and as part of a team Bachelor's or Master's degree in Chemistry or related field Experience in pharmaceutical industry or related field is a plus   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Contributing clinical expertise to patient care and providing guidance to junior physicians. Performing administrative duties and risk management. Ensuring the highest standards in patient care are maintained. Verifying complex diagnoses and facilitating treatment plans. Hiring, supervising, and mentoring healthcare professionals and collaborating with consultants. Managing allocated budgets and identifying areas of improvement in inpatient care. Keeping informed on advancements in the field and contributing to medical research programs. Ensuring compliance with healthcare regulations and safety standards. Reporting to senior management, as well as liaising between administrative and medical staff. Ensuring consistent and accurate medical recordkeeping practices.   Qualification MBBS with Tamilnadu Council Register Doctor   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities The role involves diagnosing, treating, and managing patients with various medical conditions, documenting patient information, collaborating with other healthcare professionals, and staying up-to-date with medical advancements and research.   Qualification & Experience MD in Medicine Strong clinical skills and knowledge of medical practices and procedures Excellent communication and interpersonal skills Ability to work in a fast-paced and dynamic environment Good analytical and problem-solving skills Attention to detail and accuracy in documentation Experience working in a hospital or clinical setting is preferred   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Train the medical representatives Prepare training manuals & training presentations Making medical News letters and product monographs Prepare presentation for doctor meets aligned to TA. Scientific literatures support to marketing for brand promotion Provide scientific support for New Product launches Approvals of promotional inputs for correctness from scientific and ethical perspective with Senior guidance Answer queries of the doctors and field staff KOL development Attending CME, Conference and symposium as speaker/delegate   Qualification & Experience MD Pharmacology with 1year experience in medico-marketing   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Proper and Detailed History Taking of the Patients. Counsel, the patient & the accompanying family members about the benefit of IVF and other Line of Managements we Provide for Infertility Issues. Monitor the reporting & monitoring mechanism with respect to the quality at centre & the clinic benchmark Adherence to SOP & Protocol. To check for various Consents in relevance to the Infertility Treatments we provide. Counselling Patients for Various services we provide to give Add on Results. To focus on patient Conversion. To guide the Smooth Functioning of OPD flow.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"