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 Works effectively within a team environment but may work independently delivering services within their area of competence Works within broad project guidelines as directed by the project lead and/or technical SMEs Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues Applies information provided by the project lead or senior colleagues to complete assigned project activities Produces quality work that meets the expectations of project lead and the client May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects when serving as a Project Lead Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.) Functions as the main client contact and ensures accurate project reporting is in place Ensures that the project team delivers to meet the client expectations for quality and timeliness Ensures that appropriate risk identification and issue-escalation procedures are in place Ensures project specific training compliance of the project team Ensures and/or manages project financials including provision of accurate revenue forecasts Ensures that the project team understand and work to the scope of the contract Identifies new opportunities through Change In Scope or add-on business from existing work Ensures timely project close-out activities are completed Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME Delivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SME Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and/or Technical SME Identifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutions Interacts professionally at all working levels within a client organization and within PAREXEL Identifies project and/or client needs to the Project Lead and or Technical SME and collaborates with senior staff to define a proposed solution Interactions result in clients expressing satisfaction with service provided May assist in preparing and/ or delivering a presentation with the support of senior colleagues Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope   Qualification & Experience Few years of experience in an industry-related environment Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline  

Responsibilities Conducting Research: Assist in designing and executing research studies and experiments to investigate healthcare-related questions and hypotheses. Data Collection: Collect and organize data from various sources, including literature reviews, surveys, interviews, and experiments, ensuring accuracy and completeness. Data Analysis: Analyze research data using statistical methods and software tools, such as SPSS, R, or Python, to identify patterns, trends, and correlations. Interpretation of Results: Interpret research findings and draw meaningful conclusions to inform decision-making and guide future research directions. Literature Review: Conduct comprehensive literature reviews to stay abreast of the latest developments and findings in healthcare research and related fields. Documentation and Reporting: Prepare research reports, presentations, and scientific publications summarizing study objectives, methods, results, and conclusions. Collaboration: Collaborate with cross-functional teams, including scientists, engineers, clinicians, and product developers, to integrate research findings into product development and innovation processes. Quality Assurance: Ensure compliance with research protocols, ethical guidelines, and regulatory requirements throughout the research process. Willing to travel within Bangalore and other onsite clinical research location in India   Qualification & Experience Master's or PhD degree in a relevant field, such as Biomedical Engineering, Health Sciences, Public Health, or a related discipline. Strong academic background with coursework or research experience in healthcare, biomedical research, or a related field. Proficiency in research methods and data analysis techniques, with experience using statistical software tools such as SPSS, R, or Python. Excellent analytical and critical thinking skills, with the ability to interpret complex data and draw meaningful conclusions.  

Responsibilities **Market Analysis:** Conduct thorough market research and analysis to identify trends, opportunities, and potential areas for expansion within the healthcare industry. **Strategic Planning:** Develop and execute strategic business development plans to drive growth, increase market share, and achieve revenue targets. **Client Relationship Management:** Build and maintain strong relationships with key clients, healthcare providers, insurers, and other stakeholders to drive collaboration and foster long-term partnerships. **New Business Development:** Identify and pursue new business opportunities, including client acquisitions, partnerships, and strategic alliances, to expand Wundrsight Healthcare's reach and impact. **Sales and Negotiation:** Lead the sales process from prospecting to contract negotiation and closure, ensuring alignment with company objectives and delivering value to clients. **Cross-Functional Collaboration:** Work closely with internal teams, including marketing, product development, and operations, to align business development strategies with overall company goals and objectives. **Performance Tracking and Reporting:** Monitor and analyze key performance metrics, such as sales pipelines, conversion rates, and revenue forecasts, to assess the effectiveness of business development initiatives and inform future strategies.   Qualification &  Experience MBA, Master's degree in Business Administration, Psychology, Marketing, Healthcare Management, or related field. Min. 2-3 years of experience in business development, sales, or a related role within the healthcare industry. Proven track record of achieving or exceeding sales targets and driving revenue growth. Strong understanding of the healthcare landscape, including industry trends, regulatory environment, and key players. Excellent communication, negotiation, and interpersonal skills. Strategic thinker with the ability to develop and execute plans to achieve business objectives. Highly organized, with the ability to prioritize and manage multiple projects simultaneously. Team player with the ability to collaborate effectively across departments and levels of the organization. Prior experience in the mental health, healthtech or medical device industry is a PLUS    

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 Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1 1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events.     Qualification & Expereince MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred Candidates with experience in the Cardiovascular therapy area will be preferred  

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 Assessment of change controls for registration impact and implementation of all necessary dossier changes in; Europe and International Market Responsible for compilation of the variations for the products in the product portfolio in collaboration with other stakeholders Compiling variation packages Experienced in managing, regulatory database and Trackwise.     Qualification & Experience Academic degree- and thinking level with a chemical/pharmaceutical background. 2-5 years of experience in CMC Regulatory Affairs; Mainly in Europe and International Market Knowledge on registration procedures and pharmaceutical regulations Interest and capability to work with different software, including Document Management System  

Responsibilities Support review of data within the required turnaround time, including follow up and escalations as required supporting team KPIs Prepare reports, complete review and assign comments as applicable Operate with proficiency in job related computer applications e.g., GLIMs, Microsoft Office Demonstrate ability to navigate, understand and comply to company test specifications and Pharmacopeia. Maintain clear, accurate records associated with all day to day activities. Facilitate and drive effective communication to ensure success. Liaise effectively with external groups to ensure progress of sample data review. Collaborating with others by sharing your skill set and expertise. Support and participation in Internal Investigations Ensure that all Quality Systems within the department are adhered to on a daily basis. Ensure training is current for all job functions performed Problem solving to get to root cause of issues. Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections.     Qualification & Experience ‘3 - 6 years’ experience in the Pharmaceutical, Biopharmaceuticals industry. Degree in Microbiology Good communication, interpersonal skills and ability to work across teams. Proven organizational skills and excellent attention to detail Knowledge of regulatory/code requirements to EU and US pharmacopoeia Proficiency in English, being able to speak, read and write with minimal difficulty. Proficiency in Microsoft Office and job-related computer applications required e.g., SAP, GLIM’s  

Responsibilities Imbibe the product related features/benefits including scientific information thereto, so as to effectively communicate with the medical doctors and handle product related customer queries Utilize customer focused selling techniques (CSSP), continually assessing the knowledge of the customer and strategize to maintain high customer confidence and customer knowledge of company products. Maintain current, approved protocol (CSSP) and promotional materials to be included in sales presentation/ detailing. Contact customers on regular basis and deliver informative sales presentations based on customers need. Explore opportunities to develop new business in the assigned therapy area. Achieve and exceed the sales targets on a consistent basis through effective implementation of the sales promotion strategies and scientific initiatives. Constantly update the knowledge of disease and product area so as to facilitate scientific discussion with stakeholders to enhance productivity levels as expected by the Company. Carry out Product Visibility and such ancillary or incidental activities related to the Products of the Company or Products of any other Company as may be decided from time to time, in accordance with any arrangement or agreement entered by the Company with such other Company. Explore opportunities to develop new business avenues for assigned therapy area and territory. Tactically plans to generate tertiary demand generation. Plans and executes field working as per approved tour programs and reports into data management system at regular intervals as per company expectations. Takes follow-up initiatives on feedback and customer service requirements. Handles special product campaigns, new product launch campaigns as per Company’s plans. Covers the Nursing homes, clinics and hospitals as per agreed coverage requirements. Assists in the collection of receivables, as per company policy. Work collectively with other team colleagues in arranging speakers, displays, special programs and CMEs to meet the educational needs of customers.     Qualification & Experience Degree in Sciences / B Pharm 3 or more year’s relevant experience Proven experience in articulating data-driven findings to various audience levels and translating these findings into actionable recommendations. Relevant experience in therapeutic segment Must have vaccine knowledge and selling experience at corporate hospitals with Peads, OGBynecs and Diabetologist , Pulmonologists and nephrology including trades. B. Science ( Human Anatomy & Physiology ) / B. Pharmacy