Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met Provide regulatory support for research and development activities and ensure compliance with Indian and other applicable regulations and policies A Day in the Life: Support Design and Development Control activities with regulatory requirements, direction, tactics, and strategies. Work in a team environment with all organizational departments. Job Responsibilities: Prepare, review, file, and support premarket documents for global registrations for assigned projects. Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization. Review pre-clinical and clinical protocols and associated reports for submissions. Develop Regulatory Strategies for new or modified products. Monitor and provide information on regulatory environment changes. Communicate with regulatory agencies and/or notify bodies on administrative and routine matters. Document and maintain communication with health authorities. Prepare internal documents for device modifications. Participate in health agency inspections and notified body audits as necessary. Author and/or review regulatory procedures and update as necessary. Review change control documents and assess regulatory impact. Assist in the development/maintenance of regulatory files, records, and reporting systems. Review promotional material, advertising, and labeling for regulatory compliance. Ensure compliance with regulations for MEIC developed products raw materials and prototypes. Minimum Qualifications: Bachelors degree in Medical, Mechanical, Electrical Life Science, or other healthcare-related majors. 4-7 years of experience in a Regulatory Affairs role in the medical device and/or pharmaceutical industry. Good understanding of regulations and policies issued by India, US FDA, and EU, with the ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills. Strong attention to detail and ability to handle multiple tasks. Proficient in English (reading, writing, and speaking). Good planning skills and the ability to work under pressure. Good learning attitude. Nice to Haves: Excellent communication and interpersonal skills. Self-motivated and positive attitude. Ability to quickly establish credibility with all levels of the customer base
Key Responsibilities: Perform as the ICSRs Project Lead for assigned pharmacovigilance projects. Oversee the receipt and processing of all adverse event reports, whether from spontaneous sources or clinical trials. Maintain knowledge of client-specific database conventions. Collaborate with internal or external partners for safety database reconciliation. Monitor workflow for assigned studies or programs to meet deadlines. Draft, modify, and deliver safety presentations to both external and internal stakeholders. Assist in developing departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs). Ensure ICSR regulatory submissions are compliant with both US and international regulatory reporting requirements. Understand the scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports. Experience in case processing using Argus and handling various types of cases (solicited, literature, spontaneous). Generate monthly status reports and other project-specific reports, ensuring data quality and accuracy. Conduct quality checks on case data and finalize case versions. Manage case follow-ups, including generating queries and clarifications as needed. Handle case amendments or deletions and investigate late cases to propose corrective and preventive actions. Support data reconciliation, replenishment, and clean-up activities. Assist with safety database updates and data migration projects. Identify, investigate, and resolve process or training issues, creating corrective/preventive actions (CAPAs) as necessary. Participate actively in project team and client meetings, and liaise with clients as appropriate. Prepare for and participate in internal, client, or regulatory audits, and support other functional safety leads in audit preparation. Education and Experience: M Pharmacy or Pharm D. Minimum of 10 years of experience in Pharmacovigilance (PV) Safety.
Key Responsibilities Collaborate in the development of Central Monitoring proposal text and cost reviews , contributing to overall proposal strategy when Central Medical Review is involved. Support sponsor presentations and bid defenses . Ensure timely and accurate tracking of project status and deliverables. Evaluate safety signals through both individual case assessments and cumulative data review. Contribute to the Risk Assessment and Categorization Tool (RACT) related to medical review. Support the Data Expert with critical data inputs and Electronic Data Capture (EDC) design implementation. Draft and maintain the Central Medical Review Configuration Plan throughout the study lifecycle. Manage the configuration of the Xcellerate Medical Review tool , including user acceptance testing (UAT) . Conduct ongoing Central Medical Review , escalate findings to the Project Physician , and ensure resolution of issues. Communicate data-driven decisions clearly and effectively to key stakeholders. Ensure inspection readiness for medical review activities and support regulatory inspections when required. Collaborate with other Central Monitoring functions to ensure consistency and operational efficiency. Provide training on project-specific processes to new team members. Experience and Qualifications Experience: Medical doctors with 67 years of experience in Medical Data Review . Location: Based in Bangalore , with availability to work 2 PM to 11 PM IST shift. Education: Medical degree (MBBS/MD) required.
As a PV Specialist, you will be integral to our pharmacovigilance efforts, handling key tasks such as: Data Entry: Accurately input data into the PV database. Initial Assessment: Perform initial assessments of Individual Case Safety Reports (ICSRs), as applicable. Expedited Reporting Evaluation: Evaluate the necessity for expedited reporting to Health Authorities or client partners, including adherence to reporting timelines. Reporting Preparation: Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, and XML for submission. Follow-Up Requests: Prepare and send follow-up requests to obtain additional information as necessary. ICSR Submission: Submit ICSRs to Health Authorities and client partners, ensuring compliance with regulatory requirements. Case Completion: Ensure thorough documentation and completion of cases. Quality Check: Conduct quality checks on ICSRs to maintain data integrity. Search/Retrieval: Perform the ICSR search and retrieval process from the EVWEB database and assess cases from both company and non-company sources. Case Management: Allocate and manage cases effectively within the team. Training: Provide training on the system to team members to enhance their operational capabilities. Additional Responsibilities: Undertake other tasks as assigned by the Management team. Your Profile: Experience: Minimum 1 year of case processing experience. Software Knowledge: Proficient in ARGUS and ARISG. Qualification: B.Pharm, BDS, Pharm D, or M.Pharm. Communication Skills: Excellent verbal and written communication skills. Work Environment: Willingness to work from the office in Noida.
Key Responsibilities Lead clinical studies involving healthy volunteers and patient populations , ensuring effective organization and prioritization of tasks. Own and be accountable for all Data Management (DM) deliverables , providing guidance to the DM team to maintain high-quality standards. Ensure adherence to protocols , global SOPs , and Good Clinical Practice (GCP) standards across projects. Collaborate with Project Managers to define study timelines and maintain communication with cross-functional leads throughout the project lifecycle. Provide leadership to DM project teams, coordinating internal meetings and collaborating with EDC Design , SAS Programming , and Statistics teams. Monitor project risks, develop mitigation strategies , and use data-driven insights to meet database lock timelines . Keep stakeholders informed on budget status , scope changes , and timeline impacts . Build and maintain strong client relationships , incorporating feedback from client satisfaction surveys to enhance service quality. Track and document scope changes , ensuring appropriate approvals are obtained. Mentor and coach internal teams on DM processes, best practices, and continuous improvement. Support DM managers in team performance evaluations and provide constructive feedback . Stay current with emerging DM technologies and industry trends to drive innovation. Maintain accurate records of all data management work and reconcile clinical databases with safety and lab data . Represent DM and Biometrics in business development activities , including audits and sponsor meetings. Promote Biometrics services to sponsors and perform additional responsibilities as needed. Qualifications Education University/college degree required; equivalent relevant experience may be considered in lieu of formal education. Experience 68 years of v experience , with at least 1 year of direct sponsor/client management . Experience in scope management , budget tracking , and handling client concerns is preferred. Strong understanding of the clinical trial process , including DM, clinical operations, and biometrics. Proven ability to meet project timelines with excellent time management and organizational skills . Strong interpersonal and communication skills; ability to work collaboratively in a team environment . Familiarity with medical terminology .
As a member of Safety Operations Literature team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety reporting both in general and specific to scientific literature. Individuals will perform quality review of work performed by the PV outsource vendor providing instruction and training as needed. This position collaborates with others outside of team to review, rectify and reconcile data. What you'll be doing Supervise quality of abstract review, article review, and individual cases processed by PV agencies through random QC of cases or through review of aggregate data. Provide training to outsource vendor for Literature review and case processing. This includes coordinating new hire training and certification and ongoing training and feedback for existing vendor staff. Process literature adverse event reports as needed as a part of a cross-functional team. Interface and collaborate with other functional partners at Baxter (eg, Regulatory Affairs, IT, Legal, Customer Service, etc) Collaborate with local and regional Patient Safety team members to facilitate the global exchange of safety information. Participate in compliance supervising related activities including CAPA and Quality Control Metrics. What you'll bring Bachelors or Masters degree in Pharmacy Minimum 2 years patient care, or equivalent experience AND minimum 1 year experience required as Safety Review Specialist or proficiency in a Global Safety Database (eg, ARISg, Argus) Knowledge of multiple therapeutic areas equivalent position Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department Excellent analytical & problem-solving skills Excellent oral and written communication Collaborative interpersonal skills to cultivate a team environment Ability to work independently under deadlines and changing priorities Able to multitask and prioritize changing workload every day In-depth knowledge of worldwide and regional safety regulations
Key Responsibilities Event Management: Oversee the creation, documentation, and approval process for all events in the 1CRM portal, ensuring accurate and complete information. Stakeholder Coordination: Collaborate with internal stakeholders (event requestors, engagement teams) to ensure event alignment and smooth execution. Process Optimization: Contribute to process improvements and maintain compliance with transparency and regulatory guidelines. Event Communication: Manage communications related to event execution, including attendee registration and data management via the 1CRM portal. KPI Reporting: Track and report key performance indicators (KPIs) to evaluate event efficiency and enhance cross-functional collaboration. Mentorship: Mentor and train new 1CRM Digital Asset Specialists on tools, systems, and event management processes. Adaptability: Stay up-to-date with system updates (1CRM and others) and participate in relevant training sessions. Requirements Education Bachelor's degree or equivalent. Experience 13 years of event management experience, preferably in the pharmaceutical or life sciences industry. Skills Proficiency in Microsoft Office and Veeva Vault . Familiarity with 1CRM or similar platforms. Strong organizational skills with the ability to manage multiple events simultaneously. Agile and responsive to changing business priorities. Excellent written and verbal communication skills in English. High attention to detail and proactive in solving problems.
Position Summary The role supports the Health Economics and Value Assessment (HEVA) team in the assigned therapy area portfolio to plan and generate robust health economics and value-based evidence from both a global and US perspective. The position works within the Market Access framework to ensure optimal product access and reimbursement decisions. Key Responsibilities Evidence Generation & Research Support Contribute to the HEVA evidence generation plan for pre-launch, launch, and post-launch stages. Support execution of research studies such as burden of illness, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, and patient-reported outcomes. Assist in developing economic models, trial design recommendations, and other research deliverables. Manage ongoing studies in alignment with HEVA product leads and managers. Strategic Document Development Support development of core value dossiers (CVD) and AMCP dossiers. Assist in creating strategic HEVA evidence generation materials and templates aligned with scientific and value messages. Ensure adherence to evidence generation guidelines, processes, and quality standards. Cross-Functional Collaboration Maintain effective working relationships with internal stakeholders including HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs, and Market Access teams. Coordinate with global and regional teams to identify evidence generation and dissemination needs. Prepare relevant and customized deliverables for internal and external stakeholders. Therapy Area Expertise & Innovation Develop and maintain expertise in assigned therapy areas. Seek opportunities to innovate in HEVA value identification, evidence generation, and dissemination processes. Qualifications & Experience Advanced degree in life sciences, pharmacy, or similar discipline, or a medical degree. Minimum 3 years experience in HEOR within the pharmaceutical industry, CRO, consultancy, or academia. Strong analytical, writing, and communication skills with proven stakeholder management experience. Ability to work independently and collaboratively across global teams. Fluent in English (spoken and written).
Responsibilities: Provide the required technical support in preparation of aggregate periodic reports (Examples include but are not limited to Safety Risk Management Plans, Periodic Benefit Risk Evaluation Reports, responses to PRAC assessment reports, Developmental Safety Update Reports, Medical Device Periodic Safety Update Reports, Cosmetic Undesirable Effects Reports, Canadian Annual Reports, US Periodic Adverse Drug Experience Reports, and Clinical Overviews and Summaries) Technical support which includes but is not limited to generating safety database outputs, setting up folders in relevant document management systems and working within defined document standard, rendering the final PDF document, loading the published report into the document repositories. Assist in the maintenance of the global periodic report schedule (activities can include schedule updates, quality checks, generating alerts to provide reminders to stake holders and generating metrics). Management and triage of assigned group mailboxes within Consumer Safety. Provide access to and maintain oversight of shared areas, distribution groups and Team Sites. May undertake an expert role in records management. May be appointed as an administrator in document management systems. Contribute to process improvement activities specific to record management, archiving and periodic report scheduling. Minimum Requirements: Excellent computer skills including Word, Excel, Internet/Intranet, document management systems Experience in document editing and formatting (word, pdf), fixing document errors and working with templates. Experience with quality documentation practices, data accuracy and attention to detail. Good communication skills with fluency in English both written and oral. Prior experience in Pharmaceutical Industry Ability to prioritize and manage multiple demands and projects within deadline Good presentation skills to impart technical trainings when needed
Document Management: Preparation of Active Substance Master Files, application documents for Certificates of Suitability, and Investigational Medicinal Product Dossiers, along with Quality Overall Summaries/Expert Reports for human medicinal products as part of the marketing authorization dossier. Regulatory Compliance: Strong emphasis on meeting relevant technical and regulatory requirements, as well as customer-specific demands. Strategy and Planning: Collaborate with the Business Development team on both new and ongoing projects, supporting the preparation of proposals for clients. Project Management: Ensure quality, timelines, and customer satisfaction throughout project execution; conduct gap analyses based on requirements. Lifecycle Management: Provide regulatory support to clients for their products throughout their lifecycle. Coordination and Communication: Liaise with project teams, customers, internal departments, suppliers, local partners, and regulatory bodies to facilitate essential operational procedures. Process Optimization: Assist in optimizing internal departmental processes to enhance efficiency. Knowledge Sharing: Proactively present and distribute relevant technical knowledge, including SOP training for both the organization and clients as required. Additional Tasks: Handle any other tasks that require regulatory inputs for all types of products across various markets. Your Profile: Graduate / Post-graduate / Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent. Minimum of 5 years of professional experience within the pharmaceutical industry in Regulatory Affairs. Ability to work autonomously with a focus on quality and detail. Strong teamwork skills and a sense of responsibility. Excellent command of English. In-depth knowledge of current legal and regulatory requirements in developed markets (Japan, USA, and EU). Ability to manage and prioritize multiple tasks, especially under tight deadlines. Strong organizational and communication skills. High degree of social competence with experience in virtual teams and matrix organizations.
Key Responsibilities: Lead and execute programming deliverables for complex programming projects or multiple moderate-complexity studies. Manage programming team deliverables to ensure project objectives are met on time and to the highest quality standards. Create and validate safety and efficacy analysis datasets in adherence with CDISC and client-specific standards. Generate high-quality safety and efficacy tables, listings, and figures. Develop study-specific or general macros and finalize programming specifications. Ensure adherence to programming specifications and documentation requirements. Plan and organize workload effectively to meet project-specific timelines. Communicate proactively with the biostatistics team and stakeholders to achieve study goals. Apply strong knowledge of statistical concepts using SAS programming. Adapt to changing project priorities while maintaining focus on delivery timelines. Learn and apply new techniques and technologies to enhance efficiency. Qualifications: Minimum degree in Life Sciences, Pharmacy, Statistics, or Software Engineering with 6+ years of experience in SDTM, ADaM, and TLF programming. Proficiency in creating and validating safety and efficacy tables and datasets. Strong SAS programming skills, including SAS/Base, PROC SQL, SAS/Stat, SAS Macros, and SAS/Graph. Familiarity with data structures (e.g., CDISC SDTM, ADaM) and software development lifecycle.
Assist in quality control activities under supervision. Conduct inspections and tests on products and materials. Document and report findings accurately. Follow quality control procedures and guidelines. Participate in training programs to develop QC skills.
Adverse Events and Product Quality Management: Manage and review expeditable adverse events, product quality complaints, and medical information. Submit reports to clients and regulatory agencies within agreed timelines. Process Review and Audit Readiness: Assist in process reviews and measure/monitor audit readiness. Coordinate client or external audits of assigned projects. Training and Development: Design and track training schedules and materials for new hires and existing team members. Quality Management: Contribute to quality error discussions and process improvements. Assist in developing Quality Management Plans for assigned projects. Support clients during regulatory inspections with the project team. Data Analysis and Process Improvement: Perform and review data analysis to suggest and drive process improvements. Track various types of information and metrics, conduct ongoing QC of defined process steps, and reconcile data from multiple sources. Medical Information Queries: Respond to medical information queries, product quality complaints, and general queries received via telephone, email, fax, etc Review recorded information and execute drug safety data management processes. Safety Data Management: Guide safety associates in managing voice calls as required. Review and drive strategies for process improvement/excellence. Regulatory Submissions: Review safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, Clinical Study Reports, etc General Support Activities: Perform additional support activities as assigned. Who We Are Seeking: Fortrea is looking for motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process to deliver life-changing ideas and therapies swiftly to patients in need. Why Join Fortrea: Embrace a collaborative workspace that nurtures personal growth. Make a meaningful global impact in clinical development. Join an exceptional team dedicated to innovation and excellence
Review and manage Trial Master Files (TMF) to ensure completeness and compliance. Organize and maintain TMF documents. Conduct regular audits of TMF to identify and resolve discrepancies. Collaborate with clinical teams to ensure timely and accurate documentation. Provide training and support on TMF best practices.
Project Management: Coordinate and allocate resources for PV projects, ensuring efficient workflow. Staff Training: Train and mentor PV department staff as needed. Invoicing: Ensure that monthly invoices for all PV clients are generated and distributed regularly. Compliance Oversight: Maintain up-to-date departmental CVs, job descriptions, and training records in accordance with SOPs. Training Compliance: Ensure that PV staff are compliant with training requirements at all times. Audit Representation: Represent the PV department during client audits and regulatory authority inspections. Document Review: Write and review QA documents, including SDEAs, Working Instructions, SOPs, and templates for PharmaLex PV projects. Training Organization: Organize and conduct training on the aforementioned documents. Case Processing: Handle case processing, including data entry and quality control (QC). Follow-Up Requests: Prepare and send follow-up requests as needed. Case Documentation: Complete and document cases accurately. Your Profile: Qualification: B.Pharm, BDS, Pharm D, or M.Pharm. Experience: Minimum of 5-8 years in pharmacovigilance.
Lead and oversee clinical trial activities. Ensure trials are conducted according to protocols and regulations. Manage clinical trial staff and resources. Review and approve trial documentation and data. Collaborate with stakeholders to achieve trial objectives.
Prepare, review, and submit amendments and supplements for the assigned products. Prepare summary documents for regulatory submission. Prepare, review, and submit responses to the Agency s queries for the assigned products. Compile and submit Global Annual Reports. Review stability protocols and reports, analytical method validation protocols, and reports. Review raw material, packaging material, finished product specifications, finished product stability specifications, and testing procedures. Review batch records. Review Process Validation Protocol, hold time study protocols, and reports. Review Product Development Report. Review executed documents, including executed BMR, Certificate of Analysis, to ensure compliance with regulatory requirements.
As a member of the Global Digital Hub Team, you will play a crucial role in advancing the long-term outcomes and strategy of the Global Digital Hub, while also prioritizing the delivery of high-quality content. In your capacity as a medical writer, you will focus on crafting medical writing and digital content solutions and focus on upholding the highest standards of scientific accuracy, quality and compliance. You will also be responsible for maintaining a strong knowledge of medical terminology, guidelines, and regulations to ensure the accuracy and quality of all content produced. To dive deeper, you will take the lead in developing an end-to-end content creation process and overseeing its successful delivery. In addition, you must stay up to date on industry trends and best practices in medical writing and content creation. Your (day to day) responsibilities will include, but are not limited to: Writing and editing CTDs, CSRs, IBs, protocols, manuscripts, and summaries, amongst other documents required for regulatory submissions Ensuring that the content, format, and structure comply with regulatory and other guidelines, as we'll as with Roches best practices Proactively contributing with creative ideas, concepts, or suggestions to provide added value Working cross-functionally with global teams and pharma affiliates to develop various project deliverables Partnering with the creative design team to develop infographics, images, etc Diligently keeping up to date with and following all applicable company standard operating procedures (SOPs) to meet quality standards Performing quality checks and proof-reading for accuracy Who you are You hold a bachelors degree in medical sciences or equivalent eg MBBS, Dentistry, PhD in Healthcare, Pharmacology and 5+ years of experience in a similar role. Preferably, a relevant certificate in medical writing, regulatory affairs, etc The ability to interpret medical and clinical dats
As a Medical Writer at MakroCare, the role in the development and review of clinical and regulatory documents essential for the advancement of medical research and product development. Your responsibilities will include writing and reviewing a variety of documents such as clinical trial protocols, clinical study reports, investigator brochures, and informed consent forms, ensuring adherence to established guidelines and regulations. Additionally, you will contribute to post-market surveillance activities, participate in manuscript and abstract writing, and assist in the development of templates for regulatory documents. This position offers an exciting opportunity to utilize your expertise in medical writing to support the development of innovative healthcare solutions. Responsibilities Write and review clinical/regulatory documents such as clinical trial protocols, clinical study reports/Clinical evaluation reports, investigator brochures, and informed consent forms in accordance with ICH or other relevant guidelines. Draft and document CSR (Clinical Study) and CER (Clinical Evaluation) modules. Participate in the writing of publication manuscripts, abstracts, posters, and presentations. Conduct routine systematic literature reviews for specific medical device groups or subgroups, including screening articles against inclusion/exclusion criteria, extracting data from included studies, interpreting study results, and preparing summaries into formal reports. Develop templates for reports and other regulatory documents. Education & Qualifications Bachelors or Masters degree in Life Sciences or BDS/MDS (Bachelors/Masters of Dental Surgeon) Minimum of 1-3 years of experience in Medical Writing (CSR/CER) or a related field. Skills: csr,medical writing,clinical research,evaluation tools,investigator brochures,life sciences , healthcare , manuscript , abstracts , publishing
we're looking for a proactive and highly communicative clinical research professional, pivotal in critically analyzing and summarizing clinical literature to provide valuable insights Collaborating with cross-functional teams, you will contribute to the systematic review of medical literature, ensuring that our reports adhere to rigorous standards and regulatory guidelines Join us in our commitment to excellence within the realm of clinical research and literature analysis Department - Research & Analysis Skills Required - Data Validation Role Conduct systematic literature reviews (SLR) and meta-analyses, including screening and extraction. Prepare training data for AI model development. Write clinical reports following regulatory guidelines. Ensure data accuracy and quality through thorough checks. Manage assigned projects, meet deadlines, and communicate progress. Summarize articles and create literature summaries. Utilize social media listening to identify patient-reported outcomes. Education/Qualification - Any Lifesciences degree, including B. Pharm, D. Pharm, BioMedical Engineering, BioTechnology, Microbiology, etc