Responsibilities Educating patients on cardiovascular diseases Informing them of preventative measures Counseling the patients Help diagnose and treat cardiovascular events Assist in performing diagnostic tests such as ECGs Interact with the patients as well as their families pre and post treatment Evaluate and monitor heart related devices such as pacemakers Monitor the patient and their vitals, especially cardiovascular readings Assessing and interpreting lab results   Experience 1-9 years  

Responsibilities To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions. To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy Review of documents Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. Liaise closely with cross-functional members with aligned product responsibilities. Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. Authoring the dossier sections based on the changes to approved MAA Knowledge of change evaluation according to country guidelines Experience in managing lifecycle activities in the EU markets would be preferrable Knowledge of CTD guidelines   Experience 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts  

Responsibilities Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members Plan and lead the implementation all study startup/conduct/close-out activities as applicable Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead) Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing) Site-facing activities such as training and serving as primary contact for clinical questions Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team Clinical data trend identification; provide trends and escalate questions to Medical Monitor Develop clinical narrative plan; review clinical narratives Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc. Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Collaborate and serve as primary liaison between external partners for scientific advice     Qualification & Experience Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) 5+ years of experience in clinical science, clinical research, or equivalent Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations Proficient knowledge and skills to support program specific data review, trend identification, data interpretation  

Responsibilities The Document Coordinator is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation. The Document Coordinator will interact with clinical study sites, Central/Local IRB/IECs, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo.), the study team and other functional areas within BMS and will provide support to the Study Team throughout the study duration (start-up, maintenance, and close-out of clinical studies). As the main point of contact for essential document management, ethical and regulatory submission-related activities, develops and maintains collaborative working relationships with clinical investigator sites. Support outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures. Initiate and manage start-up documentation activities for global clinical trials Generation, processing, tracking and distribution of Confidential Disclosure Agreements (CDAs). Provide input into the creation of the feasibility questionnaire; distribution and tracking of the questionnaires; provide coordinated feedback to Global Trial Manager (GTM)/Global Trial Specialist (GTS), Clinical Trial Manager (CTM), Study Team and Business Insights & Analytics (BI&A) as applicable. Submission of potential investigators to CTSS for debarment review and tracking of decisions. Review of essential regulatory documentation and interaction with sites to resolve outstanding issues, including submission of final documents to the electronic Trial Master File (eTMF) Responsible for Site Activation for clinical trials as applicable per region; this includes the final review of applicable documents, final sign-off of the site activation checklist, and submission to Regulatory. The incumbent may also be responsible for activating the site in accordance with all applicable global / local study procedures. May provide a level of quality control of start-up activity. Update and review of various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (i.e., CTMS, eTMF, etc. or corresponding vendor systems) Arrange certified translation of study level documentation from translators as requested (i.e., ICF, Protocol, IB) May assist with the coordination or creation of other study specific materials such as pharmacy or Investigator site file to ensure that these are available on site for site initiation visits/prior to first patient visit. Act as single point of contact for the study team for centralized activities during study start-up. Ongoing maintenance and tracking of essential documentation and collection of updated/outstanding documentation and submission to Regulatory as required. Managing all correspondence sent to investigative sites (i.e., IB updates, protocol amendments) and working with the sites to obtain IRB/IEC approval as needed, in collaboration with the country CTM/ CTMo. Ongoing support of Central/Local IRB/IEC process, such as submissions and approval tracking in CTMS. May support centralized IRB/IEC submission of safety events [ i.e., SUSARS, six-monthly line listings and Development Safety Update Report (DSUR)]. Ongoing submission of documents to the eTMF and review/Quality Control (QC) of the eTMF to ensure accuracy and completeness including working with sites, CTM/CTMo., and study team to resolve issues related to missing or expired documents. Ongoing communication with sites and study teams regarding centralized study activities. Lead or ensure that that the global process for the ongoing collection and review of Financial Disclosure Forms is followed as specified. Maybe responsible for creation and management of standardized document templates. Assist with generation of CSR appendices as needed. Other duties as assigned to support Clinical Trials.   Qualifications & Experience Minimum of a bachelor’s degree in legal, Life science, Business Administration, or equivalent experience. Advanced degree a plus. 1-2 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required. Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies; including formulating responses to queries. Hands-on experience of preparing, reviewing, and submitting clinical study start-up / activation documentation, including responses to queries.  

Responsibilities Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise Performance: 1) Provide deliverables (CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, ID Cards, clinical evaluation report, Briefing packages, HAQs, Immunogenicity reports) as per agreed timelines and quality 2) Fair understanding of Product Alerts, and trial transparency documents with the agility to learn and contribute to situations of demands Process: 1) Acts as an expert in the field of medical regulatory writing and maintains the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery 6) Substantial understanding of Product Alert Process and Trial Transparency documents with the ability to quickly develop expertise and contribute swiftly if the situation demands Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. 3) Collaborate with CTT, CST, GCT and SMT. 4) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables.     Qualification & Experience Experience: ≥8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment, leading project teams Technical skills: As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management; Expert knowledge of and demonstrated accomplishment in global registration of drugs) Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters, or bachelor’s in science, D Pharma, Pharm D) or medical degree (MBBS, BDS, BAMS, BHMS, MD)  

Responsibilities Supporting the Quality Assurance manager to ensure timely handling of product complaints. Take care of the EM CHC Europe complaint management inbox Ensure overview of incoming complaints and monitoring of due date at the CMO and EM CHC Europe site Assignment of incoming Complaints to the respective CMO Assessment ad categorization of the complaint Recurrence monitoring Corrective & preventive actions follow up Documentation of investigation in the system Closure of the complaint in the system Potential exchange with the affiliate Contribute to the monitoring / trending of complaints. Monthly KPI evaluation and reporting Preparation of summary for Product Quality Reviews Contribute in the annual CMO Risk ranking exercise     Qualification & Experienc 3 years in pharmaceutical environment, preferably in Quality, i.e. quality control/assurance, systems quality assurance and/or quality systems management experience in external quality management activities Qualification in Pharmacy or Natural Sciences  

Responsibilities Maintain effective relationship with the end stakeholders (medical scientific community) within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement; (2) Actively lead and develop SBO operation activities; and (3) Ensure new technologies are leveraged Performance: (1) Ensure publication/medical education materials (slide decks, abstracts, posters, and manuscripts etc.) are delivered, stored as per agreed timelines and quality; (2) Develop tools, technology, and process to constantly improve quality and productivity Process: (1) Support delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports; (2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group; and (3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards Stakeholder: (1) Work closely with scientific communication/medical content enhancement teams to ensure the end-to-end effective project delivery of the designated publication/medical education deliverables     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). Hands on experience with MLR process and exposure to relevant tools such as Veeva PromoMats or similar is desirable. Education: University degree level (Graduate degree, preferably in science). Additionally, relevant advanced/postgraduate degree in life sciences/pharmacy/similar discipline desirable  

Responsibilities Performs in vitro cell based assays and binding assays using Biacore. Performs PCR, RT-PCR, qPCR, ddPCR and gel electrophoresis etc. for mAbs, vaccine and CGT products· Develops and evaluates methods used for the measurement of biological attributes, develops  validation protocols, and execute the validation plans. Prepares final report and presents data as applicable Evaluates and analyzes scientific reports and identifies next steps and key challenges. Plan and conduct research projects independently Works with cross-functional teams within the organization to solve/support both technical and process-related issues. Performs peer-review of data along with collaborative test and research reports Keeps abreast of current trends and developments in related scientific fields, particularly in functionalm assays, binding assays, impurity analysis in mAbs, CGT and vaccines. Demonstrates strong technical skill, interest, and expertise in binding, functional and viral assays Actively engages in overall project and ensures own work is aligned with overarching goals Shares technical expertise with junior fellow lab staff and serve as a mentor for them Seeks out innovative ways to apply knowledge or skills to improve protocols and results Assists team lead in planning, implementing, and evaluating laboratory procedures/systems Supports in departmental trainings as applicable. Attends scientific seminars and conferences Follows GLP and QMS practices. Recommend improvement to systems and all other supporting activities as assigned by the team lead. Participates in internal and external audits. Aligns with USP's mission, and complies with USP's guidelines and other requirements Performs other duties as assigned.     Qualification & Experience   The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience M.Sc. in Biochemistry, or related Biological Science field with 6-8 years of Industrial experience in Bio pharmaceutical product development and quality testing, potency assay, mAb functional and binding assays (using Biacore) and molecular biology techniques. Able to analyze and interpret data using appropriate statistical software/methods and calculation for relative potency determination. An equivalent combination of education and experience may be substituted. Laboratory experience must include expertise developing and validating assays, technology transfer for monoclonal antibodies and vaccine testing, ELISA, advanced PCR techniques, viral assays.  

Responsibilities Executing the analytical tests allotted by Project Leader or Group Leader. Responsible for completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis. Coordination with group leader to ensure completion of the projects allotted to the team. Responsible for sample archival, sample tracking and chemical inventory tracking in the laboratory. Responsible for the initial review of the project reports, documents and assisting the group leader when required. Taking up any additional responsibilities assigned by group leader from time to time. Responsible for preparation and review of SOPs, protocols, reports etc. Responsible for performing the calibration of the equipment as per the schedule. Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments. Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions. Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification. Responsible to maintain and follow QMS and should handle incidents and deviations. Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.   Qualification & Experience Must have a Master’s degree in M.Sc. (analytical or organic), M. Pharma (pharmaceutical sciences or analysis) with 3 to 6 years relevant laboratory experience. Proven track record of consistently in completing the tests on time, with high quality for formulation and API’s. Proficient in chromatographic analysis, particularly in HPLC, GC. Proficient in handling other related analytical instruments such as Auto titrator, KF, FTIR, UV spectrometer, Thermal equipment’s, Elemental analyzer, SOR, TLC etc. Proficient in wet chemical analysis.    

Responsibilities Support the development, implementation and monitoring of Quality programs, policies, and procedures to ensure compliance with certifications/accreditations requirements, corporate policies, and procedures. Review/approve the following: Quality-related issues, complaints, deviations, and investigations with appropriate corrective/preventive actions. Review/approval of technical and analytical documents of moderate to high complexity for reference standard development Review/approval of change controls Method validation reports Equipment IQ/OQ/PQ documents Batch Records Lab data projects Track and trend different elements of the quality system and report on the progress of the programs, including areas of strength and opportunities for improvement on a regular basis. Drive continuous improvement initiatives across the organization utilizing quality methodologies to optimize processes and enhance efficiencies. Lead internal process/target audits according to a pre-defined schedule. Support the Supplier Quality Management program by conducting supplier evaluations, audits, and supplier performance/metrics. ISO 9001/17025: Participates in ISO 9001, ISO 17025, and other certification/accreditation activities. Performs other duties as required.     Qualification & Experience Master’s degree in science area (Chemistry, Biology) and a combination of skills and experience in the pharmaceutical or related industry. A minimum of 8-12 years of experience in Quality, including developing and implementing a Quality Management System