176 Ich-Gcp Guidelines Jobs - Page 6

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Team lead experience Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BCom

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: Any Graduation,BSc Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? Exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.-Extensive experience in database design, edit check programming, custom function programming and unit testing.-Experienced in various modules such as IVRS/RWS integration and Lab administration.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Any Graduation,BSc

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to establish strong client relationship Ability to work well in a team Collaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical Oracle Procedural Language Extensions to SQL (PLSQL) Python (Programming Language) R Programming Clinical Database Programming Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: BE/BTech/MCA Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? Clinical Database Programming Clinical Data Management Oracle Procedural Language Extensions to SQL (PLSQL) Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team SAS Clinical Structured Query Language (SQL) Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical Oracle Procedural Language Extensions to SQL (PLSQL) Python (Programming Language) R Programming Clinical Database Programming Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing (Job Code # 56) b) For Position in Pune Search : Medical Writing (Job Code # 57)

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Specialist Qualifications: BSc/Master of Pharmacy Years of Experience: 7 to 11 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

About the team: Oil & Gas This team is directly responsible for growth of Oil and Gas offline transactions & users at Paytm. About the role: Team Leader To work with the business to understand and manage Programs being run for the Clients/Brands. And for accelerating the core growth metrics focusing on sales & distribution. Provides guidance and instruction to a working group about a project or portfolio of projects. These leaders are responsible for monitoring the efforts of the team members and getting the work done effectively and efficiently with the proper utilization of resources. Skills that will help you succeed in this role: 2+ yrs. of experience in Distribution sales in fintech, Banking/ Sales, EDC Sales. Develop plans and strategies for developing business and achieving the company's sales goals. Create a culture of success and ongoing business and goal achievement. Manage the sales teams and resources to deliver growth. Hire and build a new team to support our growing needs and future projects. Define optimal sales force structure. Define and coordinate sales training programs that enable staff to achieve their potential and support company sales objectives. Manage customer expectations and contribute to a high level of customer satisfaction. Define sales processes that drive desired sales outcomes and identify improvements. Going to the Merchant and educating him/her about the benefits of the Swipe machine (EDC) converting them and managing their accounts. Exceptional communication, presentation skills and relationship building skills. Ability to aggressively manage the successful execution of a sales strategy. Ability to work independently and collaboratively in a team environment. Qualifications: Bachelor's degree in business, marketing, or a related field (MBA preferred). Should have a strong understanding of the local language. Self-motivated and goal-oriented, with a demonstrated ability to work independently and as part of a team. Willingness to travel as needed to meet with clients and attend industry events.

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices. Project Coordination Assist in planning, tracking, and executing departmental projects and initiatives. Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates. Required Knowledge and Skills: Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors. 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies. Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner. Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction. Familiarity with GxP requirements and systems validation. Life Sciences, Biotech or pharmaceutical industry experience. Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault Familiarity with global regulatory processes and standards. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. Basic Education and Experience: Bachelor’s degree and 2 years of directly related experience Associate’s degree and 6 years of directly related experience High school diploma / GED and 8 years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP 5+ years’ experience in data management, machine learning, or related fields

JOB DESCRIPTION 1) ARD Scientist (Analytical Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: ARD Sr Scientist/Jr Scientist capable in developing and validating analytical methods and Validation including calibration to ensure the quality and stability of pharmaceutical products. Key Responsibilities: Develop and validate analytical methods for drug substances and drug products. Perform analytical testing such as HPLC, GC, and wet analysis. Interpret analytical data to assess product quality, purity, and stability. Implement GLP & GDP practices. Prepare technical reports and documentation for regulatory submissions. Collaborate with the FRD & DQA to support product development. Troubleshoot analytical method issues and recommend improvements. Qualifications: Masters degree or Ph.D. in instrumental analysis, Analytical Chemistry, or related discipline. Expertise in analytical techniques such as HPLC, GC, and spectroscopy. Strong knowledge of regulatory guidelines such as ICH and FDA. Good documentation and report-writing skills. Problem-solving and analytical thinking abilities. Minimum 3(or) More Years for Junior scientist of experience in ARD /Q.C . For Sr Scientist 8 (or) more years of experience is desired 2) FRD Scientist (Formulation Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: FRD Sr Scientist/Jr Scientist is responsible for the research and development of pharmaceutical formulations, ensuring the products are safe, stable, and effective for consumption. Key Responsibilities: Design, develop, and optimize formulations for pharmaceutical or nutraceuticals Etc. Implementation of QbD . Conduct experiments to test product stability, and efficacy. Prepare technical documents, including formulation protocols and reports. Collaborate with cross-functional teams such ARD, DQA Etc to ensure compliance. Troubleshoot formulation issues and propose solutions. Qualifications: Masters degree in pharmaceutics or Ph.D. in Pharmaceutics & Equivalence, Minimum 3(or) More Years for Junior scientist of experience in FRD /R&D . For Sr Scientist 8 (or) more years of experience is desired Strong understanding of Good Manufacturing Practices (cGMP). Problem-solving skills and GDP implementation Skills in usage of software for developing of formulation and characterization. Excellent communication skills to present findings and collaborate with teams. Exposure in developing Liquid Orals, Solid Orals, Semi-Solid Orals. Nano formulations will be preferred 3) DQA Team (Development Quality Assurance Sr. Executive) Positions Sr Executive -1 Jr Executive -1 job Description: DQA Sr. Executive should monitor the quality assurance processes during product development, ensuring that all stages comply with quality standards and regulatory requirements and product specification need as per ICH Guidelines. Key Responsibilities: Lead quality assurance activities for product development, including design, testing, and validation stages. Ensure compliance with regulatory guidelines and quality standards (e.g., FDA, EMA, GMP). Develop and implement quality control procedures for new product development. Conduct internal audits and prepare quality assurance reports. Collaborate with R&D, ARD to implement the quality issues. Manage risk assessment processes and ensure continuous improvement in quality systems. Should have knowledge in QbD system for product development. Qualifications: Minimum experience should be 6-8 Years for sr executive and 1 to 3 years for junior executive in DQA (or) Q.A Bachelors or Masters degree in Quality Assurance /Analysis/Pharmaceutics, In-depth knowledge of cGMP, GDP, GLP, ICH and regulatory requirements and implementation. Excellent communication and problem-solving skills.

Filter in of technical requests under his /her ownership to ensure qualitative service provided to the customers. Responsible for filter in and submitting of technical requests. Filter out and response to customers to ensure qualitative service provided to the customers. Close follow-up on pending service requests, in order to get a complete and accurate answer. Coordinate between the BUs and customers on technical requests on a daily basis. Streamlining and following all processes in order to obtain an optimal support/service. Building trustworthy relationships with customers, considering the various backgrounds Back up of other team members as per requirement. Coordinate between the BUs and AMs/ customers on technical requests on a weekly/ daily basis. Coordinating and participating TCs with customers. Dealing with complicated issues such as complaints, long pending SRs, sensitive customers etc. Weekly follow up meeting with AM to promote long pending issues. Initiation of new high level ideas to be used as a service/ marketing tool to further improve the service and create an ongoing service discussion with customers and AMs. Responsible for sending customer notifications With technical background-QA/QC/RA/R&D

Role & responsibilities Review and submission of ANDA 505 (J) application for US market. CMC writing, Query management, Labeling, RIMS, Drug Listing, Pre-and Post-Approval Changes (Life cycle management) and Publishing as per USFDA/EU. Proficient in cross functional team communication with internal and external stakeholders. Functional experience in end to end project management and handling team Preferred candidate profile Candidate must have experience in Regulatory filling and product life cycle management for in EU & US markets Perks and benefits 20lpa to 30 lpa

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to establish strong client relationship Ability to work well in a team Collaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Skill required: Clinical Data Services - Medical Monitoring Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.Provides medical expertise for trial oversight and safety concerns. This includes creation, review and validation of protocol requirement specifications as per the applicable SOP. What are we looking for? Ability to work well in a team Adaptable and flexible Strong analytical skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BTech,Bachelor of Pharmacy,Master of Pharmacy

Job Description: Clinical Research Manager Position Overview The Clinical Research Manager (CRM) in a specialty pharmaceutical company plays a pivotal role in the design, execution, and management of clinical studies (BE/BA/TE) focused on innovative and specialized therapies. This position requires a strong background in pharmacokinetics, pharmacology, and clinical research, with a keen understanding of the unique requirements of specialty pharma products. The CRM will oversee end-to-end clinical research activities to ensure timely, compliant, and successful study outcomes. Key Responsibilities 1. Clinical Study Design and Execution Lead the design, planning, and implementation of clinical studies, particularly in areas requiring pharmacokinetic and pharmacology expertise. Monitor and report the studies at CRO Develop study protocols, investigator brochures, and other study-related documents in collaboration with cross-functional teams. Manage timelines, budgets, and resources to ensure project deliverables are met within scope. 2. Specialty Pharma Expertise Apply pharmacokinetics and pharmacology knowledge to optimize study designs for niche or complex therapeutic areas. Support bioavailability, bioequivalence, and drug interaction studies to meet regulatory requirements for specialty pharma products. Collaborate with formulation and regulatory teams to align clinical studies with product development goals. 3. Regulatory and Compliance Oversight Ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP) and local regulatory requirements. Manage interactions with regulatory agencies, IRBs, and ethics committees. 4. Team Leadership and Project Management Lead and mentor clinical research associates, coordinators, and other team members involved in clinical studies. Timely execution of projects Manager vendors, including CROs, labs, and other service providers, ensuring high-quality deliverables. Foster collaboration among internal and external stakeholders to support study objectives. 5. Data Management and Analysis Collaborate with data management teams to ensure accurate collection and analysis of clinical studies data. Review and interpret clinical data, particularly pharmacokinetic and pharmacodynamic results, to assess drug safety and efficacy. Provide scientific insights to inform regulatory filings, publications, and strategic decisions. Qualifications Educational Background: Advanced degree (Masters, PharmD, or PhD) in Pharmacokinetics, Pharmacology, or a related field. Experience: 5-8 years of clinical research experience, preferably in specialty pharma, with at least 2 years in a leadership role. Demonstrated expertise in pharmacokinetics, including modelling, simulation, and interpretation of PK/PD data. Experience in managing early-phase clinical studies, bioequivalence studies, or rare disease programs. Technical Skills: Strong knowledge of pharmacokinetic principles, drug metabolism, and specialty pharma therapeutic areas. Proficiency in clinical trial software (e.g., Medidata, Trial Master File systems) and pharmacokinetic tools (e.g., NONMEM, WinNonlin). Familiarity with regulatory submission processes for specialty pharmaceuticals. Soft Skills: Excellent leadership, project management, and problem-solving skills. Strong communication skills for collaborating with cross-functional teams and presenting complex scientific data. Detail-oriented and adaptable to the dynamic nature of specialty pharma development. Preferred Qualifications Certification in Clinical Research (e.g., SOCRA, ACRP). Experience in rare diseases, oncology, or other specialty therapeutic areas. Track record of regulatory interaction and successful trial submissions in specialty pharma. Work Environment and Benefits Work in a highly collaborative, innovative, and fast-paced environment. Competitive compensation and benefits package, including health insurance, performance bonuses, and professional development support. Opportunities to contribute to groundbreaking treatments in niche therapeutic areas.

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Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more careers bms com/working-with-us Responsibilities Responsibilities will include, but are not limited to Study Startup Draft EDC build timeline in collaboration with Data Management Lead Perform DB build tasks by creating specifications for Database and Edit Checks Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan Study Conduct Plan/execute Post Production/Migration for the study (if any) Coordinate with Clinical Data Managers for the execution of data review tasks Coordidate with external data vendors for any escalations related to any vendor data Support Clean Patient Group delivery along with Clinical Data Management staff Update study documents as needed during the conduct of the study Support DML to coduct Data Quality Review meetings Provide Data Health Metrics to Data Management Lead as requested Study Closeout- Support Data Management Lead in planning and execution of database lock activities Perform post lock activities, as needed Project Management Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality Documentation Filing of appropriate documents in eTMF as per eTMF master plan Training and Mentorship Provide Training and mentoring to junior CDM staff Bachelor's Degree required Life sciences, Pharmacy or relevant fields preferred 6 years of experience in managing end to end Clinical Data Management tasks Able to work on end to end Clinical Data Management tasks Able to work collaboratively on multi-disciplinary project teams Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills Strong oral and written communication skills Strong project management skills Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Company Name: Exemed Pharmaceuticals ( Formulation Business) Designation: Sr. CT QA-Auditor Experience Range: 4-5 years Required Qualification: B. Pharm or M. Pharm (Pharmacology) or Msc in Clinical Research Name of Replacer, Please Specify: New Position Required Skill Set: 1. Must have experience of CT Phase 3 & Phase 4 Audits 2. Ready for travelling 3. Familiar with ICH-GCP guidelines 4. Proficient with MS excel, MS word and Power point 5. Experience with oncology trials is an additional advantage Job Description (Compulsory): 1. Prepare audit agenda, checklist and reports 2. Conduct and oversee audits of investigators site, vendors facilities and systems 3. Review of Site Master File 4. Review trial related documents such Study Protocols, CRFs, ICDs and Patient diary, Investigators Brochures and Patient diaries 5. Participate in regulatory inspections 6. Prepare various reports, intimation letters and arrange meetings as required 7. Communicate identified risks to reporting manager.

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Associate Qualifications: BCom Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model – powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for? Collaboration and interpersonal skills Problem-solving skills Strong analytical skills Numerical ability Ability to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Strong knowledge of clinical trial data management principles, practices, and regulatory requirements. Proficiency in using clinical data management systems and electronic data capture (EDC) tools. Solid understanding of database design, data coding, and data validation techniques. Excellent attention to detail and problem-solving skills, with the ability to identify and resolve data discrepancies. Strong organizational and project management skills to effectively manage multiple projects simultaneously. Proficient in using statistical software, such as SAS or R, for data analysis and reporting. Excellent communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders. Familiarity with clinical data standards, such as CDISC (Clinical Data Interchange Standards Consortium), is a plus. Knowledge of regulatory requirements, including Good Clinical Practice (GCP) guidelines and Health Insurance Portability and Accountability Act (HIPAA) regulations. Strong ethical and professional conduct to ensure data privacy and confidentiality. Contact HR SHIVA - 8438813362( What'sapp)

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms com/working-with-us Key Responsibilities And Major Duties Responsible for activities related to study start up and ongoing study document management Act as point of contact for local study teams and external stakeholder Independently manages study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval This includes substantial amendments and any other documentation requiring HA submission Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission) Collaborates with other internal roles in country feasibility and site selection Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines Prepare country Informed Consent Form (ICF) and manage country ICF template Review and approval of Site ICFs Review and approval of Clinical Trial Package (CTP) documentation Update national registries as applicable Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management When applicable, conduct drug/IMP label review & translation Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal May support the collection and distribution of documents from / to sites including obtaining insurance certificates May support Health Authority inspection and pre-inspection activities May support audit preparation & Corrective Action / Preventative Action preparation for local related issue Minimum Qualification and Experience: Bachelor's degree required preferably within life sciences or equivalent Thorough understanding of GCP, ICH Guidelines and Country regulatory environment In depth knowledge and understanding of clinical research processes, regulations and methodology Demonstrated organizational and planning skills and independent decision-making ability Strong organization and time management skills and ability to effectively manage multiple competing priorities Ability of critical thinking and risk analysis Good verbal and written communication skills (both in English and local language) Minimum of 2 year industry related experience If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol Responsibilities BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations