Responsibilities Process study documentation in accordance with SOPs, Work Instructions, ICH?GCP, regulatory guidelines, and study?specific requirements Support TMF set?up, maintenance, and closure activities across assigned studies Perform document scanning, indexing, filing, and uploading in electronic TMF (eTMF) systems Ensure security, accuracy, and compliance of TMF documents for both active and archived studies Conduct Quality Reviews of TMF documents submitted by study teams Perform Completeness Reviews against Expected Document Lists to identify missing or incomplete TMF contentQualification & ExpeirenceBachelor’s or Master’s degree in Life Sciences or related field: BSc / MSc / B. Pharm / M. Pharm / BDSMinimum of 1+ years of experience as a E-TMF Specialist or 2+ years of exp. as a Clinical Research Coordinator (CRC) or within a clinical research environment (preferred), with an understanding of clinical trial documentation and applicable regulatory guidelines

Responsibilities Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Develops or supports a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and client presentations. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team providing review comments on draft and final documents. Adheres to established regulatory standards, including but not limited to Journal/congress specific guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Familiarity with figure-creation and data visualization software, including tools such as GraphPad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics.

Responsibilities Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc., associated with Sun Pharma Pharmacovigilance operations.  Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.  Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit reports, CAPA reports and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance.  To assure that the CAPAs are adequately addressed and closed.  To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA.  Responsible for review of Pharmacovigilance SOPs for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.  To prepare and review departmental SOPs  To assist in monthly report preparation  Management training and records of GPvP-QA team through LMS  Support operations team during corporate audit/ external audits Collaborate with cross-functional teams to ensure quality standards are met across all pharmacovigilance activities.  Lead the assessment, tracking of global actions and monitoring of identified actions as part of various corporate initiatives.  To perform any other responsibilities assigned with regards to the R&D Quality system. Maintain documentation and records in accordance with quality and regulatory standards. Qualification & Expeirence Post Graduate in Pharmacy (M. Pharma) OR BDS  Around 2 years of experience in Pharmacovigilance Quality Assurance OR 2 years’ experience in PSUR/Signal management 

Responsibilities  Protocols: Direct development of statistical designs and analysis procedures for scientific protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected. Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol. Assist in developing project and functional standards of data collection and analysis, and implement these standards.  Database Activities: Collaborate with data sciences, statistical programming and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs. Contribute to data monitoring plans. Develop and implement project specific data standards. Ensure accuracy and consistency of data released for statistical analysis.  Statistical Analyses: Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results. Provide sufficient details to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Determine need for development of novel statistical methodology.  Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analysis. Prepare oral and written reports to communicate results. Represent data and statistical sciences on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and publications and high quality.Qualification & ExperiencePh.D. or M.S. in Biostatistics or Statistics. Experience: At least 2+ years for PhD (or 5+ years for M.S.) of industry experience or equivalent in a pharmaceutical R&D environment.

Responsibilities  Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc., associated with Sun Pharma Pharmacovigilance operations.  Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.  Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit reports, CAPA reports and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance.  To assure that the CAPAs are adequately addressed and closed.  To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA.  Responsible for review of Pharmacovigilance SOPs for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.  To prepare and review departmental SOPs  To assist in monthly report preparation  Management training and records of GPvP-QA team through LMS  Support operations team during corporate audit/ external audits Collaborate with cross-functional teams to ensure quality standards are met across all pharmacovigilance activities.  Lead the assessment, tracking of global actions and monitoring of identified actions as part of various corporate initiatives.  To perform any other responsibilities assigned with regards to the R&D Quality system. Maintain documentation and records in accordance with quality and regulatory standards.Qualification & Experience Post Graduate in Pharmacy (M. Pharma) OR BDS  Around 2 years of experience in Pharmacovigilance Quality Assurance OR 2 years’ experience in PSUR/Signal management 

Responsibilities   Responsible for planning and delivering development related projects according to the established goals, while working with regulatory, formulation, BD, analytical, MSTG, QC, QA and the launch team.  Responsible for establishing project documentation frame work and methodology  Manages and maintains the project budget.  Monitors progress and periodically provides project updates  Manages project issues, identifies and manages risks and deliverables  Must be able to facilitate discussions and bring about consensus between all stakeholders. Timely highlight the issues at appropriate forum and drive the resolutions.  Must be able to use project management tools effectively to track and (MS Project, CCPM, Gantt charts, Presentations)  Responsible for bringing the project to closure, which may include creating an end of project report or evaluation document, holding 'Stage gate' meetings and activities, and capturing and using relevant lessons learned.  Should understand the technology being used in order to understand and question requests coming from specialists and technical staff and to evaluate what is reasonable or possible.  Effective Coordination; right and timely communication between various CFT members to make them aware of Company’s priority, towards achieving Shared Goals  Should have knowledge of basic regulatory requirements in India and understanding of technical side and project complexities.

Responsibilities Preparation and implementation of SOPs, STPs, formats, and records for injectable operations including cartridge / PFS and isolator-based filling lines.  Execution of document control activities including issuance, revision, and archival.  Initiation and tracking of change controls related to facility, equipment, utilities, and documentation.  Support deviation documentation and investigations during commissioning and qualification phases. - Support CAPA implementation and tracking.  Cross-functional coordination with QA, QC, Engineering, Validation, and Projects teams.Qualification & ExperienceEducation: B.Pharm / M.Pharm / B.Sc / M.Sc Experience: 7–8 years in Injectable / Sterile Operations QMS

ResponsibilitiesAchieve sales targets for assigned oncology products and accounts. Develop and execute territory and key account business plans. Build strong relationships with oncologists, hospital administrators, and procurement teams. Ensure effective scientific and promotional discussions with healthcare professionals. Identify new business opportunities in hospitals and cancer centers. Monitor market trends, competitor activities, and customer insights. Work closely with Medical, Marketing, and Regulatory teams for brand strategy and compliance. Ensure product availability and coordinate with supply chain for key accounts. Maintain accurate records of customer interactions, sales activities, and business plans. Ensure compliance with company policies and industry regulations.  Additional Responsibilities Support medical education programs, CMEs, and marketing initiatives. Provide market feedback and strategic inputs to management. Participate in review meetings and sales planning discussions. Support new product launches in the oncology segment. Maintain strong internal coordination with cross-functional teams.Qualification & ExperienceBachelor’s Degree in Pharmacy / Life Sciences / Science MBA (Preferred)  Experience Minimum 2–5 years of pharmaceutical sales experience Oncology therapy exposure preferred Experience in handling institutional / hospital business is an advantage

Qualification & Experience           Desired Qualification : BSc Nursing / GNM        Preferred experience Minimum : Experience - Preferred in Pediatric Nursing care                     

Qualification & ExpeirenceExperience: 15–18 Years Qualification: M.Pharma / B.Pharma