Qualification & Experience Relevant University Degree in Science or related discipline Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry Thorough knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams Regulatory affairs experience across a broad range of markets Managed regulatory deliverables at the project level Experience of working with people from locations outside of India, especially Europe and/or USA Excellent English written and verbal communication skills Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions  

Responsibilities Perform Lead Biostatistician role on simple studies, providing statistical oversight and attending relevant project meetings Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate Preparation of Statistical Analysis Plans (including mock TFL shells) for simple and medium complexity studies under the supervision of senior statistical staff Perform statistical analysis for medium complexity studies Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery Review CRF and other study specific specifications and plans ? May perform sample size calculation for Clinical Pharmacology studies under the supervision of senior statistical staff Provide statistical input and review of the CSR for simple studies Generation and review of randomization schedules from provided specifications under the supervision of senior statistical staff  

Responsibilities You will be responsible for leading and managing a team of experts in the field of nutrigenomics. Your day-to-day tasks will include overseeing research projects, developing data-driven strategies, and providing guidance on genetic-based personalized nutrition interventions. You will collaborate with cross-functional teams to drive innovation and develop cutting-edge solutions to improve human healthspan.   Qualifications Advanced degree (Ph.D. or equivalent) in Nutrigenomics, Genetics, Molecular Biology, or related field Proven experience in nutrigenomics research and application Strong knowledge of genetics, genomics, and personalized nutrition Experience in leading and managing a team of researchers Ability to analyze and interpret genetic and nutritional data Excellent communication and collaboration skills Publication record in the field of nutrigenomics Experience with laboratory techniques and equipment Ability to stay updated with the latest research and advancements in the field Passionate about improving human health span and increasing lifespan Experience 4+ Year Above  

Responsibilities Represent CSQA and participate in the review and approval of computer system documentation throughout the lifecycle of an application. Review and approval of change requests through to closure of computerized systems and infrastructure as applicable. May interact with regulators during regulatory inspections and provide relevant documentation as required. Conduct/Manage/Support/ routine computer compliance audits (internal & external) as well as computer compliance initiatives. Identify computer related business, regulatory or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Establish improvement processes, as needed, or set specific measurable targets and goals linked to CSQA/GQA/GSK business needs. Contribute to or lead the training, education, guidance and influencing of GSK R&D staff on best quality and computer compliance policy and practices. Identify and mitigate computer compliance risks to GSK through effective audits and/or via providing advice and consultancy to GQA and business units regionally and globally. Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments. Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by CSQA management.    

Responsibilities Direct the delivery team to take ownership and deliver best possible outcomes through a sound data management, analytics and operations mindset. Work closely with stakeholders to ensure expansion and penetration of Omni use-cases with medical teams. Create a framework for communication, project management and execution across BUs to help drive best practices Take ownership of design, development, maintenance and operations Be a mentor for team members, and drive upskilling plans for LCCI team Serve as trusted career advisor, and work with functional leadership and HR to identify career opportunities for these team members, both systemically (career path development) and with individuals as needed Develop a pipeline of right talent and leadership, and contribute to an inclusive community of analytics expert practitioners Drive standardization, automation agenda across business units to help scale the delivery operations     Qualification & Experience Master’s degree in management/ pharmaceutical or a related field from a premium college Bachelor’s Degree with 12+ years of relevant experience in an allied fucntions such as: BI, data analytics, Omnichannel, integrated marketing, supporting Pharma/Lifesciences Commercial or Medical ops internally or in consulting; at least 6+ in leading teams  

Responsibilities Product or Molecule Safety Physician / Lead Physician Provide global medical leadership and input into all aspects of safety of assigned product(s) including surveillance programs and risk management planning. Ensure proactive safety surveillance: lead risk management activities for assigned products globally lead and guide the surveillance activities of scientists on the team including signal detection and clarification activities and risk evaluation activities; provide support, training and continued improvement as appropriate manage decisions and actions to be taken, including communication to appropriate customers (e.g., Product Teams, Management, Affiliates and Regulators) and liaise with GPS Medical Area Directors and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safety obligations; Supervise and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities, represent PV position to Global Patient Labeling Committee and/or the Safety Review Committee as appropriate. Build collaborative working relationships with other Global Patient Safety Physicians and development and brand teams medical globally to ensure full cooperation and high quality medical evaluation of safety data for global regulatory purposes. Represent GPS Medical and/or Product on appropriate committees/product development and brand teams. Provide medical support for Global Patient Safety activities and reports within the department, as appropriate. Provide Global Patient Safety expertise to internal customers (e.g., regulatory, early phase development, business units). Provide medical input for review of Adverse Event cases. Lead process and provide medical input for review of Suspected Adverse Reactions Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of laws, regulations and guidance. Understanding and Support of the QPPV role Understanding the roles and responsibilities of the European Union Qualified Person (QPPV) and ensure their involvement in the pharmacovigilance system and processes. Ensure support and information are provided to enable the QPPV to fulfill all the QPPV legal responsibilities. Training, coaching and mentoring Provide training, coaching and mentorship to safety surveillance scientists, and other GPS Medical physicians and clinical research scientists with respect to medical aspects of safety surveillance Provide Global Patient Safety training for development and brand team physicians and clinical research scientists and other audiences (e.g. Regulatory, Lilly Medical) as appropriate. Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map. Maintaining compliance with the Lilly Corporate Integrity Agreement. Global Patient Safety Leadership  

Responsibilities Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. Conduct effective document initiation meeting to ensure authoring team alignment and understanding. Build scientific-based rationale that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy. Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Work with internal and external experts to develop and prepare presentations. As needed, may build and manage relationships with vendors/alliance partners.     Qualification & Experience Graduate degree with formal research component or in life sciences. Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields. Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Experience writing regulatory, clinical trial documents and/or publications  

Responsibilities Sr. CDM will be involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools. Takes a leadership role with SRP/SRS to establish, align and confirm scientific clinical data review expectations for assigned trial(s). With the SRP/SRS, CRO and other functional partners in relation to CDM related activities: Reviews content for eCRF and other data collection tools Establishes conventions and quality expectations for clinical data. Set timelines and follow?up regularly to ensure delivery of all relevant Data Management milestones. Sr. CDM reviews complex scientific clinical study data, manages CDM and SRP/SRS related queries in eDC system and collaborates with Study Responsible Physician/Study Responsible Scientist (SRS/SRP). Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible. Sr. CDM will lead and/or attend meetings, as appropriate. Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements. Ensures real?time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and J&J internal audits as necessary. Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time. Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level. Identifies and participates in process, system, and tool improvement initiatives within DM.     Qualification & Experience MS degree or PhD in Science or BS/BA degree in Science with professional experience equivalent Minimum of 3 years Data Management experience, specifically data review including patient profile experience, clinical data review or significant experience with clinical data review knowledge of medical terminology. Collaboration with Clinical teams Experience in clinical drug development within the pharmaceutical industry or CRO Strong scientific knowledge (educational/professional) preferably in the relevant therapeutic area  

Responsibilities Develop, review, and evaluate clinical guidelines and Drug Utilization Reviews, provides consultations, develops programs, prepares articles, and conducts research.   Assess the identity, strength and purity of medications. Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability. Provide information and advice regarding drug interactions, side effects, dosage and proper medication storage. Analyze prescribing trends to monitor patient compliance and to prevent excessive usage or harmful interactions. Order and purchase pharmaceutical supplies, medical supplies, and drugs, maintaining stock and storing and handling it properly. Maintain records, such as pharmacy files, patient profiles, charge system files, inventories, control records for radioactive nuclei, and registries of poisons, narcotics, and controlled drugs. Advise customers on the selection of medication brands, medical equipment and health-care supplies. Collaborate with other health care professionals to plan, monitor, review, and evaluate the quality and effectiveness of drugs and drug regimens, providing advice on drug applications and characteristics. Compound and dispense medications as prescribed by doctors and dentists, by calculating, weighing, measuring, and mixing ingredients, or oversee these activities. Offer health promotion and prevention activities, for example, training people to use devices such as blood pressure or diabetes monitors. Prepare sterile solutions and infusions for use in surgical procedures, emergency rooms, or patients' homes. Plan, implement, and maintain procedures for mixing, packaging, and labeling pharmaceuticals, according to policy and legal requirements, to ensure quality, security, and proper disposal.     Qualifications & Experience Able to work accurately and with minimal supervision. Ability to comprehend written instructions given by the Doctors and the other related departmental personnel. Ability to plan & organize ones work schedule effectively. Speaking and listening are essential requirements to understand and carry out the instructions given by the supervisors and other related departmental personnel. Affinity to work in team. Enthusiasm. Open-mindedness.

Responsibilities As a Director of Patient Safety, you will manage a team of Patient Safety staff locally. You will develop strategies and objectives for Patient Safety in your area of responsibility, ensuring alignment with broader AstraZeneca goals. You will maintain a high degree of understanding and awareness of internal and external trends influencing the PS domain, sharing this knowledge with your team. You will build networks with other teams and external stakeholders to learn about new developments, leverage opportunities, and share best practices. You may manage or support projects to improve processes within Patient Safety or develop and introduce new technologies and approaches at the national, regional, or global level.     Qualifications & Experience Medical degree/ Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development Experience in Patient Safety in the pharmaceutical industry Excellent communication skills Project management experience Knowledge of relevant legislation and developments in the Pharmaceutical industry Medical or other life science degree or appropriately qualification as Health Care Professional PV Professional (Scientist) Experience in either writing Risk Management Plans and assessing risk mitigation activities or in translating preclinical safety experience to humanPh.D. in a scientific discipline Expert reputation within the business and industry Extensive knowledge of the latest technical and regulatory expectations Line management experience