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5.0 - 10.0 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the job role of Medical Writer Job Description: 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 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57
Posted 2 months ago
6.0 - 11.0 years
6 - 7 Lacs
Bengaluru
Remote
Experienced in documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market. Or emerging market like Africa. ROW - rest of the world market Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool
Posted 2 months ago
3.0 - 8.0 years
3 - 5 Lacs
Bengaluru
Remote
Job Description: Assist and manage (as applicable) in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components. Support and delivery of submission ready packages to agreed timelines and management of information required. Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications. Prior experience in Veeva vault is preferable. Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables. Develop research skills relevant information, regulations, and guidance from different regulatory agencies. Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination. Assist in the preparation of agendas, presentations, and other supporting materials for various meetings. Contribute to the development and improvement of related business processes. Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required. Ensure the learning from own projects are shared with other colleagues/within the functions. Skills Required : Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool Good Knowledge Documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market.
Posted 2 months ago
3.0 - 5.0 years
3 - 5 Lacs
Mumbai Suburban
Work from Office
Job Title/Description: Associate MPD Process AMA PHC, BB Duration: 1 year in the beginning [ basis business need & performance may be continued further] Required Qualification & experience: M. pharm. Pharmaceutics Location: GOA, Mumbai Note: Third Party Payroll Job - Ashkom Media India Pvt LTD. Required Skills: Work Experience: 3 - 5 years in pharmaceutical Formulation development + Technology Transfer. Formulation development + stability study management Roles: To assist in making QC Soft entries for report generation of various stability results compilations, Raw material samples co-ordination, protocol, report review To support to MPD Process/ADL technical team in making batch records & other MPD Technical documentation To support in indent, receive of raw material and analysis at MPD Goa lab. To support MPD - Process Team in Enovia Technical specification data management To assist in reviewing of various technical documents (e.g. PV Protocol- Reports, TT, MFR) of which draft is shared by respective project leader of MPD To assist the team in raising purchase request in Coupa software. To participate in other tasks i.e. Office administrative task assigned by MPD-GO Mumbai 8) To Help MPD Process technical team members in Change control management, Department SOP review, issuance management Responsibilities To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) To maintain track of on-going/work in progress CCPs /closer of change controls To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. Support to MPD Process/ADL technical team in making batch records & other MPD documentation. QC Soft entries for report generation of various stability, Raw material samples, protocol printing. Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for Sending samples for outside testing with proper documentation To participate in other tasks assigned by MPD- team members e.g., TT document review Supplier qualification technical document review, To liaison with RM suppliers for receipt of material qualification document, safety document & its review. Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pin code - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com
Posted 2 months ago
3.0 - 5.0 years
3 - 5 Lacs
Mumbai Suburban
Work from Office
Job Title/Description: Associate MPD Process AMA PHC, BB Duration: 1 year in the beginning [ basis business need & performance may be continued further] Required Qualification & experience: M. pharm. Pharmaceutics Location: GOA, Mumbai Note: Third Party Payroll Job - Ashkom Media India Pvt LTD. Required Skills: Work Experience: 3 - 5 years in pharmaceutical Formulation development + Technology Transfer. Formulation development + stability study management Roles: To assist in making QC Soft entries for report generation of various stability results compilations, Raw material samples co-ordination, protocol, report review To support to MPD Process/ADL technical team in making batch records & other MPD Technical documentation To support in indent, receive of raw material and analysis at MPD Goa lab. To support MPD - Process Team in Enovia Technical specification data management To assist in reviewing of various technical documents (e.g. PV Protocol- Reports, TT, MFR) of which draft is shared by respective project leader of MPD To assist the team in raising purchase request in Coupa software. To participate in other tasks i.e. Office administrative task assigned by MPD-GO Mumbai 8) To Help MPD Process technical team members in Change control management, Department SOP review, issuance management Responsibilities To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) To maintain track of on-going/work in progress CCPs /closer of change controls To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. Support to MPD Process/ADL technical team in making batch records & other MPD documentation. QC Soft entries for report generation of various stability, Raw material samples, protocol printing. Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for Sending samples for outside testing with proper documentation To participate in other tasks assigned by MPD- team members e.g., TT document review Supplier qualification technical document review, To liaison with RM suppliers for receipt of material qualification document, safety document & its review. Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pin code - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com
Posted 2 months ago
3.0 - 6.0 years
5 - 9 Lacs
Kolkata
Work from Office
Subject matter experts in Marketing and Comms provide business stakeholders with specialized advice on their subjects, and act as an advisor leveraging on a specific MC expertise. She/he is a person with in-depth, unique knowledge and expertise on a specific subject or in a particular industry ex digital marketing, internal comms, telecom, etc. : Familiarity with metadata management and tagging best practices. Exceptional attention to detail, with a strong ability to spot errors and inconsistencies in large datasets or digital assets. Strong analytical skills with the ability to identify data quality issues and root causes and implement corrective actions. Ability to work effectively with cross-functional teams, including marketing, creative, IT, and product teams, to resolve data issues and ensure alignment across the organization. Strong problem-solving skills to address data discrepancies, identify issues within workflows, and propose effective solutions. Proven track record of optimizing data management processes, improving workflows, and implementing data quality initiatives. Primary Skills: 4-6 years of experience in digital asset management, with a focus on maintaining data accuracy and consistency across systems. 2+ years Sitecore/Aprimo/AEM OR Veeva any one Digital Asset Management tools. Secondary Skills: Familiarity with data validation tools, reporting platforms (e.g., Excel, Power BI), and basic SQL or query languages for managing and analyzing data. Excellent written and verbal communication skills, with the ability to document processes, provide training, and explain data issues clearly to both technical and non-technical stakeholders.
Posted 2 months ago
4.0 - 9.0 years
27 - 42 Lacs
Hyderabad
Work from Office
Years Of Exp - 3-9 Yrs Location - PAN India Job Summary We are seeking a highly skilled Testers with 3 to 9 years of experience in Selenium Salesforce Core Java and Advanced Java or MSDynamics /MSCRM/Veeva CRM. This hybrid role requires a proactive individual who can ensure the quality and reliability of our software solutions contributing to the company success and positive impact on society. Responsibilities Lead the testing efforts for various projects ensuring high-quality deliverables. Oversee the development and execution of test plans and test cases. Provide technical expertise in Selenium Salesforce Core Java and Advanced Java or MSDynamics /MSCRM/Veeva CRM. Collaborate with cross-functional teams to ensure seamless integration and delivery. Identify document and track defects ensuring timely resolution. Develop and maintain automated test scripts to improve testing efficiency. Ensure compliance with industry standards and best practices in testing. Mentor and guide junior testers fostering a culture of continuous improvement. Conduct regular reviews and provide feedback to improve testing processes. Analyze test results and provide detailed reports to stakeholders. Ensure the testing environment is set up and maintained for optimal performance. Stay updated with the latest trends and advancements in testing technologies. Contribute to the overall improvement of the software development lifecycle. Qualifications Must have strong experience in Selenium Salesforce Core Java and Advanced Java. Must possess excellent problem-solving and analytical skills. Should have a proven track record of leading testing projects successfully. Must be able to work effectively in a hybrid work model. Should have strong communication and collaboration skills. Must be detail-oriented and able to manage multiple tasks simultaneously.
Posted 2 months ago
4.0 - 8.0 years
6 - 10 Lacs
Hyderabad
Work from Office
The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ?with 9 to 13 yrs of experience. Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Posted 2 months ago
3.0 - 8.0 years
6 - 10 Lacs
Hyderabad
Work from Office
The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ? Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Posted 2 months ago
8.0 - 12.0 years
10 - 14 Lacs
Hyderabad
Work from Office
About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master’s/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
3.0 - 8.0 years
3 - 6 Lacs
Hyderabad
Work from Office
The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS edit check programming Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? Proven experience in managing teams General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ?with 9-13 years of experience Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Posted 2 months ago
4.0 - 6.0 years
14 - 17 Lacs
Hyderabad
Work from Office
Manager, CSAR - Global Library Manager What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Advanced degree in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Knowledge: Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Systems development lifecycle Programming Languages Project planning and management Quality management Regulatory filings and inspections Understanding of CDISC and SDTM Process improvement methodologies What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
3.0 - 8.0 years
1 - 4 Lacs
Bengaluru
Remote
Preferred candidate profile Exp: 3+Yrs Notice period: Not more than 30 days Location: Anywhere Proficient/Good working experience in Veeva Vault. Should have very good technical understanding of the tool
Posted 2 months ago
1.0 - 4.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Job title: Senior Analyst CRM Country Support Hiring Manager: Team Lead Location: Hyderabad, About The Job Strategic context: Sanofi has currently the best and most robust pipeline of R&D and consequent new launches of our history As new phase of Play-To-Win strategy, funding this pipeline and new launches is key to materialize the miracles of the science to improve people lives Thus, as we enter the next phase, modernization of Sanofi is required as per the recent announcements on DRIVE, and in this respect, we are in the beginning stages of organizing the Go-to-Market Capabilities (GTMC) team at global level, The GTMC organization will help us to drive best-in-class capabilities across the board and bring value and excellence in our commercial operations This move is a key part of the aimed modernization of Sanofi and will allow us to focus on our priorities across our products, market and pipeline through the reallocation of resources and realizing the efficiencies of removing silos that exist between our business units, avoiding the duplication and overlapping of resources, standardizing our processes and tools, operating with a One Sanofi approach to accelerate our key capabilities development, and fostering the entrepreneurial spirit by speeding up the decision making, Customer Facing CRM & Platforms Team Aims For Centralize Go-to-Market excellence and operational tasks across Global Business Units (GBUs), Standardize best-in-class capabilities with strengthened global support while verticalization of reporting within GTMC from local to global, Define clear ways of working and bringing clarity on interfaces with GBUs, Digital, and executional support on commercial operations from Sanofi hubs to optimize process excellence and efficiency, Main Responsibilities Create and maintain surveys/coaching forms and dynamic attributes, including data loads and ongoing maintenance, Maintain and govern customer master data, HCP/HCO profiles, territory alignments, affiliations, and call activity data Perform data validation, enrichment, and deduplication to maintain a clean and reliable CRM database Support data integration and alignment updates between Veeva and other platforms Execute and support territory management processes such as alignments and roster updates, Set up and maintain Global Core Ratings, create templates and load into OneCRM, do cross check; troubleshooting any issues, Create for end users platform/system alerts, ensuring timely notifications of an start and end period, Setting up and loading TOT template (Time off territory) for end users, Manage and handle troubleshooting on behalf of end users regarding on country-specific needs, Create Service Requests to AIMS, check execution of work done by AIMS Deploy and manage both standard and new modules securing country readiness, Data stewardship; raise ticket, reverify data after correction (OneCRM/OneCI) Provide automatic translation releases, training materials and fields in the system Execute country specific test scripts for UAT (User Acceptance Testing) Veeva Align OCCP, incl feedback module and Veeva Align Territory Administration o Ensure on time, continuous seamless OCCP (OmniChannel Call Plan) orchestration and deployment including feedback and Territory administration in the Veeva Align modules for all GBUs (GenMed, Vaccines and Speciality Care) o Support to One CRM countries, Veeva Align including OCCP feedback, tasks like preparation of files uploads, tagging and reporting of all activities related to Veeva Align Veeva Align territory administration, Tasks like field force creation and changes, territory creation and changes, product creation, account rules, explicit assignment deletion etc will be weekly activities, Monitor the usage of OneCRM including newly released features, Load data and ensure data consistency in the module (new contract templates, invitations, mass upload, some profile) Content: Ensure on time delivery, management, upload, tagging and reporting of all digital assets and content ordered and approved for distribution through the major content management systems (Veeva Vault, 1CRM, Veeva 4MPromo Mat, DAM -Digital Asset Management & other CMS Tools, etc) by collaborating with colleagues from the medical, marketing, compliance, IT and local affiliates as well external agencies, photo studios and other creative sources such as stock libraries, Ensure that content is received properly with all added supporting information key words, focus areas, categories, grouping as well as other data that should be available within the Content for conversion and upload on the system, Demonstrable expertise in complex Veeva CLM development and deployment with teams and managing stakeholder interaction, Serve as the Project originator for routing completed Veeva CLMs through the testing process before handoff to the global, regional, or local teams in a highly regulated environment, Responsible for quality control and technical viability of assets to be uploaded, Ensure that the tagging and metadata of content is consistent and appropriately applied to all assets for the region and functions, Build/ Develop Veeva CLM via content provided from teams in a Veeva CLM creation platform in alignment with instructions provided, Partner closely with Medical Teams to ensure the most up to date and efficient search capabilities are applied and used in the most competent way Analyse metadata, subtypes, search fields, and security policies, and identify inefficiencies and consider new solutions to ensure the digital content are being utilized at their highest potential, Create, update, and distribute all necessary digital asset guidelines to ensure that all current processes are followed and kept relevant, Responsible for testing the content within platform on performance, content format and on interactive elements (hotspots, links, etc) Receive QC approval and then distribute content to appropriate user group for UAT, Providing training sessions to MSLs or various countries on Veeva Vault application Mentor and train 1CRM digital asset specialists and create/update all training guidelines and materials as needed, Build and maintain intranet and internet websites using platforms such as SharePoint, People: (1) Maintain effective relationships with stakeholders;(2) Liaise and coordinate with colleagues in medical function to receive content for dissemination through one CRM (3) Co-ordinating and performing QC activities to ensure quality check validation and UAT acceptance Performance: (1) Manage receipt of Content including content Approval documentation as per set quality standards;(2) Perform initial QC on content to test rendering, performance and interactive;(3) Perform trouble shooting content-related technical issues;(4) Timely distribute content to appropriate QC user group (5) Enhance content structure and digital asset management learnings;(6) Build and maintain intranet and internet websites Process: (1) Follow detailed guidelines (for example checking metadata which have links to pdf review of the content for assessment, format, expiration date, tagging, validating MMRC#); (2) Secure adherence to QC process to maintain quality requirement, About You Work Experience: 5+ Years of Experience with tools like SQL, Excel, Power BI/Tableau (preferred), Years of experience in CRM administration, preferably with expertise in managing Veeva CRM, Strong knowledge of data governance, quality management, and territory alignment concepts, Commercial Operations knowledge and desirable experience supporting in-field teams, Proven experience in CRM administration, preferably with expertise in managing Veeva CRM, Proven delivery of outstanding results, Excellent problem-solving skills and attention to detail, Ability to leverage networks, influencing and leading projects, Ability to lead change while achieving business goals and objectives, act for change, challenging continuously the status quo, High persistency and resilience, Knowledge Robust knowledge on ?VEEVA CRM?, ?Veeva 4M? and ?VEEVA ALIGN? for all user roles (front and back-office), Experience with tools like Excel, SQL, Power BI/Tableau (preferred), Good understanding about Veeva Vault, 1CRM, Veeva 4MPromo Mat; Effective understanding on content structure Excellent English language knowledge and skills (written and oral), IT knowledge and skills, proven impactful communication, presentation, persuasion, skills ability to work cross-functionally, Experience in having deployed transformational GTM solutions and new customer facing tools implementation, Skills And Competencies Business: Numerate and analytical skills; Ability to prioritize; Robust knowledge in Digital, IT and CRM; Ability to work on their own initiative and make quality decisions; Excellent interpersonal skills to communicate, present, persuade and argument among all GBUs teams and partners, Leadership: Leads by example and walks the talk; Role models Play-To-Win principles and behaviours: Engages others through active and impactful communication; Demonstrates a high level drive, passion and ambition for high performance; Challenges continuously the status quo; Develops fresh approaches in order to deliver results; Has well-developed time management skills, mastering in prioritizing tasks and planning own workloads to ensure deadlines and desired results are met, Networking: Is a strong relationship builder; Seeks out new opportunities; Demonstrates teamworking and shares best practices always; Has experience of successfully leading projects in multicultural environments and in a matrix organization, Education: Graduate/Postgraduate or Advanced degree in areas such as Management/Statistics/Decision Sciences/Engineering/Life Sciences/Business Analytics or related field (e g , PhD / MBA / Masters) Languages: Excellent knowledge in English and strong communication skills written and spoken Personal Characteristics Hands-on, accountability, creativity, initiative, high persistence and resilience, stress management, learning agility, result orientation, ability to work on ones own, continuous improvement, listening skills, empathy to understand the needs of the different businesses within distinct geographies, Why chose us Bring the miracles of science to life alongside a supportive, future-focused team, Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally, Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact, Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeksgender-neutral parental leave, Play an instrumental part in creating best practice within our Go-to-Market Capabilities, Pursue progress, discover extraordinary Progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen You can be one of those people Chasing change, embracing new ideas and exploring all the opportunities we have to offer Lets pursue progress And lets discover extraordinary together, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi com! null Show more Show less
Posted 2 months ago
1.0 - 4.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Job title: Senior Analyst CRM Country Support Hiring Manager: Team Lead Location: Hyderabad About The Job Strategic context: Sanofi has currently the best and most robust pipeline of R&D and consequent new launches of our history As new phase of Play-To-Win strategy, funding this pipeline and new launches is key to materialize the miracles of the science to improve people lives Thus, as we enter the next phase, modernization of Sanofi is required as per the recent announcements on DRIVE, and in this respect, we are in the beginning stages of organizing the Go-to-Market Capabilities (GTMC) team at global level, The GTMC organization will help us to drive best-in-class capabilities across the board and bring value and excellence in our commercial operations This move is a key part of the aimed modernization of Sanofi and will allow us to focus on our priorities across our products, market and pipeline through the reallocation of resources and realizing the efficiencies of removing silos that exist between our business units, avoiding the duplication and overlapping of resources, standardizing our processes and tools, operating with a One Sanofi approach to accelerate our key capabilities development, and fostering the entrepreneurial spirit by speeding up the decision making, Customer Facing CRM & Platforms Team Aims For Centralize Go-to-Market excellence and operational tasks across Global Business Units (GBUs), Standardize best-in-class capabilities with strengthened global support while verticalization of reporting within GTMC from local to global, Define clear ways of working and bringing clarity on interfaces with GBUs, Digital, and executional support on commercial operations from Sanofi hubs to optimize process excellence and efficiency, Main Responsibilities Create and maintain surveys/coaching forms and dynamic attributes, including data loads and ongoing maintenance, Set up and maintain Global Core Ratings, create templates and load into OneCRM, do cross check; troubleshooting any issues, Create for end users platform/system alerts, ensuring timely notifications of an start and end period, Setting up and loading TOT template (Time off territory) for end users, Manage and handle troubleshooting on behalf of end users regarding on country-specific needs, Create Service Requests to AIMS, check execution of work done by AIMS Deploy and manage both standard and new modules securing country readiness, Data stewardship; raise ticket, reverify data after correction (OneCRM/OneCI) Provide automatic translation releases, training materials and fields in the system Execute country specific test scripts for UAT (User Acceptance Testing) Veeva Align OCCP, incl feedback module and Veeva Align Territory Administration Ensure on time, continuous seamless OCCP (OmniChannel Call Plan) orchestration and deployment including feedback and Territory administration in the Veeva Align modules for all GBUs (GenMed, Vaccines and Speciality Care) Support to One CRM countries, Veeva Align including OCCP feedback, tasks like preparation of files uploads, tagging and reporting of all activities related to Veeva Align Veeva Align territory administration, Tasks like field force creation and changes, territory creation and changes, product creation, account rules, explicit assignment deletion etc will be weekly activities, Monitor the usage of OneCRM including newly released features, Load data and ensure data consistency in the module (new contract templates, invitations, mass upload, some profile) Content: Ensure on time delivery, management, upload, tagging and reporting of all digital assets and content ordered and approved for distribution through the major content management systems (Veeva Vault, 1CRM, Veeva 4MPromo Mat, DAM -Digital Asset Management & other CMS Tools, etc) by collaborating with colleagues from the medical, marketing, compliance, IT and local affiliates as well external agencies, photo studios and other creative sources such as stock libraries, Ensure that content is received properly with all added supporting information key words, focus areas, categories, grouping as well as other data that should be available within the Content for conversion and upload on the system, Demonstrable expertise in complex Veeva CLM development and deployment with teams and managing stakeholder interaction, Serve as the Project originator for routing completed Veeva CLMs through the testing process before handoff to the global, regional, or local teams in a highly regulated environment, Responsible for quality control and technical viability of assets to be uploaded, Ensure that the tagging and metadata of content is consistent and appropriately applied to all assets for the region and functions, Build/ Develop Veeva CLM via content provided from teams in a Veeva CLM creation platform in alignment with instructions provided, Partner closely with Medical Teams to ensure the most up to date and efficient search capabilities are applied and used in the most competent way Analyse metadata, subtypes, search fields, and security policies, and identify inefficiencies and consider new solutions to ensure the digital content are being utilized at their highest potential, Create, update, and distribute all necessary digital asset guidelines to ensure that all current processes are followed and kept relevant, Responsible for testing the content within platform on performance, content format and on interactive elements (hotspots, links, etc) Receive QC approval and then distribute content to appropriate user group for UAT, Providing training sessions to MSLs or various countries on Veeva Vault application Mentor and train 1CRM digital asset specialists and create/update all training guidelines and materials as needed, Build and maintain intranet and internet websites using platforms such as SharePoint, People: (1) Maintain effective relationships with stakeholders;(2) Liaise and coordinate with colleagues in medical function to receive content for dissemination through one CRM (3) Co-ordinating and performing QC activities to ensure quality check validation and UAT acceptance Performance: (1) Manage receipt of Content including content Approval documentation as per set quality standards;(2) Perform initial QC on content to test rendering, performance and interactive;(3) Perform trouble shooting content-related technical issues;(4) Timely distribute content to appropriate QC user group (5) Enhance content structure and digital asset management learnings;(6) Build and maintain intranet and internet websites Process: (1) Follow detailed guidelines (for example checking metadata which have links to pdf review of the content for assessment, format, expiration date, tagging, validating MMRC#); (2) Secure adherence to QC process to maintain quality requirements About You Work Experience: 5+ years of experience in CRM administration, preferably with expertise in managing Veeva CRM, Commercial Operations knowledge and desirable experience supporting in-field teams, Proven experience in CRM administration, preferably with expertise in managing Veeva CRM, Proven delivery of outstanding results, Excellent problem-solving skills and attention to detail, Ability to leverage networks, influencing and leading projects, Ability to lead change while achieving business goals and objectives, act for change, challenging continuously the status quo, High persistency and resilience, Knowledge Robust knowledge on ?VEEVA CRM?, ?Veeva 4M? and ?VEEVA ALIGN? for all user roles (front and back-office), Good understanding about Veeva Vault, 1CRM, Veeva 4MPromo Mat; Effective understanding on content structure Excellent English language knowledge and skills (written and oral), IT knowledge and skills, proven impactful communication, presentation, persuasion, skills ability to work cross-functionally, Experience in having deployed transformational GTM solutions and new customer facing tools implementation, Skills And Competencies Business: Numerate and analytical skills; Ability to prioritize; Robust knowledge in Digital, IT and CRM; Ability to work on their own initiative and make quality decisions; Excellent interpersonal skills to communicate, present, persuade and argument among all GBUs teams and partners, Leadership: Leads by example and walks the talk; Role models Play-To-Win principles and behaviours: Engages others through active and impactful communication; Demonstrates a high level drive, passion and ambition for high performance; Challenges continuously the status quo; Develops fresh approaches in order to deliver results; Has well-developed time management skills, mastering in prioritizing tasks and planning own workloads to ensure deadlines and desired results are met, Networking: Is a strong relationship builder; Seeks out new opportunities; Demonstrates teamworking and shares best practices always; Has experience of successfully leading projects in multicultural environments and in a matrix organization, Education: Graduate/Postgraduate or Advanced degree in areas such as Management/Statistics/Decision Sciences/Engineering/Life Sciences/Business Analytics or related field (e g , PhD / MBA / Masters) Languages: Excellent knowledge in English and strong communication skills written and spoken Personal Characteristics Hands-on, accountability, creativity, initiative, high persistence and resilience, stress management, learning agility, result orientation, ability to work on ones own, continuous improvement, listening skills, empathy to understand the needs of the different businesses within distinct geographies, Why chose us Bring the miracles of science to life alongside a supportive, future-focused team, Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally, Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact, Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeksgender-neutral parental leave, Play an instrumental part in creating best practice within our Go-to-Market Capabilities, Pursue progress, discover extraordinary Progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen You can be one of those people Chasing change, embracing new ideas and exploring all the opportunities we have to offer Lets pursue progress And lets discover extraordinary together, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity, Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi com! null Show more Show less
Posted 2 months ago
4.0 - 5.0 years
8 - 9 Lacs
Hyderabad
Work from Office
Role & responsibilities Role : Third Party Data Acquisition Study Analyst * Collaborate closely with the Third Party Data Acquisition Study Analyst to facilitate the setup and acquisition of external clinical data at the study level during study startup, conduct, and closeout phases. * Ensure data accuracy, completeness, and consistency through effective cleaning, validation, and transformation processes. * Monitor data feeds regularly to uphold data quality and accuracy. * Support the setup of infrastructure enabling external data integration into client's clinical data pipelines. * Provide guidance and coordination to vendors on data acquisition systems, including GlobalScape, Veeva FTP, Veeva training, and IP whitelisting. * Review incoming data from multiple sources to confirm compliance with Data Transfer Agreements (DTA) regarding format, file extensions, and field requirements. Validate all third-party data generated during clinical trials for integration into Clients clinical data ecosystem. * Assist the Third Party Data Acquisition Study Analyst in conducting periodic Trial Master File (TMF) reviews per the study TMF plan. * Adhere to procedural documents and participate in their review and updates to ensure alignment with industry standards, regulatory requirements, and best practices. * Coordinate with and review deliverables from external partners (e.g., labs, eCOA providers, technology vendors) performing services for Client. * Appropriately escalate issues to the Third Party Data Acquisition Study Lead. * Routinely monitor proprietary applications for scanned mail and distribute documents to relevant teams.Perform regular quality checks to ensure optimal system performance and data integrity. Preferred candidate profile
Posted 2 months ago
2.0 - 4.0 years
9 - 11 Lacs
Bengaluru
Work from Office
Overview About Role: We have an exciting role of Medical Editor - Sr. Analyst to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About Omnicom Global Solutions Omnicom Global Solutions (OGS) is an agile innovation hub of Omnicom Group, a leading global marketing and corporate communications company. Guided by the principles of Knowledge, Innovation, and Transformation, OGS is designed to deliver scalable, customized, and contextualized solutions that meet the evolving needs of our Practice Areas within Omnicom. OGS India plays a key role for our group companies and global agencies by providing stellar products, solutions, and services in the areas of Creative Services, Technology, Marketing Science (Data & Analytics), Advanced Analytics, Market Research, Business Support Services, Media Services, and Project Management. We currently have 4000+ awesome colleagues in OGS India who are committed to solving our clients’ pressing business issues. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together! Why Omnicom Health (OH) At Omnicom Health, you’re not just starting a job—you’re becoming part of something bigger. As one of the largest and most specialized global healthcare networks, we’re dedicated to building the ideas and solutions of tomorrow. Your career here is about growth, impact, and the chance to shape the future of healthcare. Every day, the work you do will contribute to a greater cause, making a real difference in people’s lives About our Agency DDB Remedy - At DDB Remedy we DARE TO DO BOLDLY because health cannot wait. The pace of healthcare is accelerating — and we love it. There’s nothing more important than health and we need to stay a step ahead. Well-positioned to meet the unique needs of clients without losing sight of quality and personalized attention, we match talent to task, pulling from in-house experts. Steeped in oncology, rare-disease, and general medicine, DDB Health boldly communicates the most complex scientific brand information to deliver simple impact. Responsibilities Backup editor on brands, bring energy, organization, and attention to detail. Know the data, the competitors, client style, and AMA style well. Be the editor, fact checker, and proofreader for a variety of promotional and educational materials for physicians, other healthcare professionals, and patients from manuscript through release. Recognize the different editorial requirements needed for print and digital pieces. Be proficient in underlying interactive technologies, such as web and mobile. Have knowledge of AMA style, grammar, and usage, and good working knowledge of computer programs (as applicable to the department). Be able to communicate well with supervisors and internal brand team. Be able to take feedback constructively, have respect for teammates with regard to attendance, communication, and participation in workload. Collaborate with Project Management, Copy, Art, and Account Services. Manage the timing and quality control of projects, including copy editing, styling, and fact checking. Be eager for real-time feedback, with an eagerness to learn and advance. Observe and promote leadership skills in others. Our global medical communication agency teams. You will also be closely collaborating with our team of talented and designers to deliver high-quality services. Qualifications Bachelor’s degree in science, preferably related to medicine or pharma Required Skills: 5-8 years of relevant work experience, preferably in science, medicine, or at a pharmaceutical communications / advertising agency. Proficiency in Microsoft Office (Word, Outlook, Excel, PowerPoint) and Adobe Acrobat. Familiarity with Veeva PromoMats and PubMed Extremely detail-oriented and organized approach to work Ability to work collaboratively with multiple departments and levels within the agency Strong team-oriented approach and excellent interpersonal skills Ability to thrive and grow in a fast-paced environment Ability to prioritize deadlines and work under pressure A passion for sciences and regulations Location: Bangalore/ Chennai
Posted 2 months ago
5 - 10 years
6 - 10 Lacs
Bengaluru
Work from Office
Department - Commercial GBS Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment. About the Department The Commercial, GBS unit is responsible for creating insights to launch a product, Market intel, Forecasting, Multichannel customer engagement planning, Global Brand Strategy & Tactics. Comprising of Project Management, Brand Management, Brand Communications, Life cycle Management of a product. The Position We are seeking a Sr. Associate Digital Content Manager for developing digital assets for Interactive Sales Aids, Emailers, and Website pages. This role requires strong technical skills in UI development and effective collaboration with multiple teams and stakeholders. Some of the Key Responsibilities for this role are: Develop and maintain emailers, EDA slides, web pages, web components, and assets to support brand promotion. Perform unit testing before passing the output to the Quality team. Collaborate with both internal and external team members to achieve effective results. Work closely with teams to address identified issues and implement enhancements. Follow the defined development process to ensure top-quality output. Continuously upgrade UI technical skills to meet business demands. Troubleshoot issues in web content and webpages. Train and mentor junior developers. 70% Production (EDA, Emailer & Web pages), 30% - Process Documentation, Trainings, Support. Qualifications MSc., B.Sc. B.E or similar graduate degree in relevant field (Computer Science, IT Quality, Website Development) 5+ years of experience working with digital content development using web standards like HTML5, CSS, jQuery and JavaScript. Good understanding of web standards in conjunction with any CRM platform (OCE personal / Veeva) Strong knowledge of responsive layouts and libraries. Skill in JavaScript and any libraries/frameworks is a plus. Excellent English communication skills and comfort in working with different cultures. Fluency in written and spoken English.
Posted 2 months ago
5 - 8 years
10 - 20 Lacs
Gurugram
Remote
Job responsibilities • Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. • Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. • Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. • Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports • Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. • Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. • Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. • Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. • Performs system integration activities, application updates, and user acceptance testing. • Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. • Assists in project meetings and actively contributes and participates in departmental review meetings. • Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. • Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. • Manages project resources, proactively alerting management of delivery and resourcing needs. • Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. Qualifications What were looking for • Bachelor’s degree preferred, or equivalent combination of related education and experience. • 5 years of experience, must have Data visualization experience in Spotfire/Tableau/PowerBI (Useful) • Experience with either Python/SAS/SQL. • Clinical background experience is a must, with preferred experience in iMedidata Rave & Veeva EDC. • Good to have Spotfire API experience/knowledge. • The ability to deal effectively with sponsors and internal customers at all levels. • Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. • Demonstrated experience in managing multiple priorities in a highly dynamic environment • Experience working in a matrix-structured environment is preferred • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail • Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. • Ability to travel as necessary (up to 25%)
Posted 2 months ago
4 - 8 years
17 - 22 Lacs
Bengaluru
Hybrid
Veeva Platform Engineer - Payments Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Purpose and Scope: As a Platform Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. An Enterprise Business Platforms Engineer focuses on the development, deployment, and integration of software platforms that support our business processes and operations. This role involves a blend of technical expertise, business acumen, and a deep understanding of Veeva Clinical Platform. The goal is to ensure these platforms are optimized to support business goals, enhance efficiency, and drive growth. You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field. Essential Job Responsibilities: Platform Development and Configuration: Design, develop, and configure business platforms to meet the specific needs of our organization. This could involve programming, configuring settings, and integrating various software solutions. System Integration: Ensure seamless integration between different business platforms and systems (e.g., integrating CRM and ERP systems) to enhance data flow and business processes. Performance Monitoring and Optimization: Regularly monitor the performance of business platforms, identify bottlenecks, and implement optimizations to improve efficiency and user experience. User Support and Training: Provide technical support to platform users, resolve issues, and conduct training sessions to ensure users can effectively utilize the platforms. Initiative Execution: Actively participate in and contribute to various initiatives, applying your specialized skills to achieve the objectives and expected Value. Contribute to the ongoing realization of Value from these enterprise platforms through continuous integration and deployment. Collaboration: Work collaboratively with team members within the subdivision and across other digital and business units. Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise. Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities. Reporting: Regularly report on the progress of the various Value Teams and outcomes to your Capability Lead and team members. Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions. Quality Assurance: Ensure the highest quality and consistency in the work delivered. Requirements Qualifications: Required Bachelors degree in relevant field, e.g., Computer Science, Data Science Minimum of 3-5 years of demonstrated relevant experience Demonstrated experience in developing and configuring in the Clinical Operations space using Veeva Vault Payments Business Process Understanding: Knowledge of Clinical operations business processes and how Vault Clinical supports these processes Strong analytical and problem-solving skills Ability to work effectively in a team environment Excellent communication skills, both written and verbal Agile and adaptable to changing environments and project scopes Present technical solutions based on the business requirement of the Clinical Veeva system. Able to support technical upgrade on quarterly basis by conducting technical impact assessment, addressing any technical issues, support the environment management, support testing, and document changes per the SLC process Manage user account, create roles, and support quarterly user access review request. Support system deliverables and provide technical feedback during internal and external Veeva Clinical system audit Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during the technical upgrade Preferred Veeva Admin Certification 1-3 years demonstrated experience with Veeva Vault Clinical Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery Technical Proficiency: Strong coding skills in relevant tools and technologies, e.g., Java, C++, Python, R, SQL is highly beneficial
Posted 2 months ago
4 - 8 years
17 - 22 Lacs
Bengaluru
Hybrid
Platform Engineer / Business Analyst - Veeva R&D Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Purpose and Scope: As a Platform Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. As a business analyst, you will be responsible for understanding the needs of the end users, across commercial and medical business domains, and utilizing your knowledge and experience in Veeva R&D suite of products to demonstrate to end users how best to meet their requirements. You will then translate these requirements into well-defined user stories that the system engineers can rely on to develop, test, and deploy the required changes made to the systems. Essential Job Responsibilities: Business Requirements Analysis: Collaborate with business stakeholders to understand their needs, goals, and objectives. Analyse business processes and workflows to identify improvement opportunities and define requirements for solutions. Technical Specification Development: Translate business requirements into detailed technical specifications that guide the development of software applications, systems, or processes. Ensure that these specifications meet both the business needs and technical standards. Solution Design and Recommendation: Work with Digital and software development teams to design solutions that fulfil business requirements. Evaluate potential technical solutions for feasibility, cost-effectiveness, and alignment with business objectives. Stakeholder Collaboration: Serve as a liaison between business units and technical teams to ensure clear communication and understanding of project goals, requirements, and constraints. Facilitate meetings and discussions to gather feedback and consensus. Project Management Support: Assist in project management tasks, such as planning, scheduling, and tracking progress. Ensure that projects stay on track to meet deadlines and budget constraints. Testing and Quality Assurance: Participate in the testing of developed solutions to ensure they meet the defined requirements and standards. Assist in identifying and documenting bugs or issues for resolution. Training and Support: Develop training materials and provide support to users on new systems or applications. Ensure that end-users are equipped to use the new solutions effectively. Documentation: Create and maintain documentation related to business requirements, technical specifications, project plans, and reports to ensure knowledge is captured and shared. Requirements Qualifications: Required Minimum 3 years of experience in commercial and medical business analysis at a Life Science organization, focusing on Veeva R&D suite of products, including Vault Clinical, RIM, Quality, Safety. Knowledge and experience in R&D domains in Life Science / Pharma industry Demonstrated experience in business analysis, technical analysis, or a related area, demonstrating a track record of bridging business needs with technical solutions. Analytical Skills: Strong analytical and problem-solving skills to understand complex business issues and develop appropriate technical solutions. Experience in Agile methodology, DevOps, CI/CD principles and practices. Technical Knowledge: Good understanding of information technology, software development life cycles, and architectural frameworks. Communication Skills: Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders and vice versa. Collaboration: Ability to work effectively in a team environment, collaborating with diverse groups of stakeholders, including business users, Digital professionals, and management. Attention to Detail: Precision in documenting requirements, specifications, and project details to ensure clarity and alignment with objectives. Adaptability: Flexibility to adapt to changing requirements, technologies, and project priorities. Preferred Veeva Certified Administrator Familiarity with programming languages, databases, and software development tools is beneficial. Certifications in Agile delivery methodologies (e.g., SCRUM, SAFe) Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery
Posted 2 months ago
3 - 8 years
4 - 7 Lacs
Hyderabad
Work from Office
The Manager, CSAR - Electronic Data Interchange and Acquisition What you will do Let’s do this. Let’s change the world. About The Role The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electronic Data Interchange and Acquisition will develop the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. Manager, CSAR - Electronic Data Interchange and Acquisition will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors. Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related field with 9-13 years of experience. Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
6 - 8 years
14 - 17 Lacs
Hyderabad
Work from Office
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
Posted 2 months ago
4 - 7 years
4 - 7 Lacs
Hyderabad
Work from Office
About The Role We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Study build and Edit check development Programming Languages ? Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with experience range of 9-13 years Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline ? Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Posted 2 months ago
4 - 6 years
3 - 6 Lacs
Hyderabad
Work from Office
Manager, CSAR - SAS Edit Check Programmer What you will do Let’s do this. Let’s change the world. The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Proficient in SAS edit check programming Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience. Master’s degree and 4 to 6 years of experience. Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Posted 2 months ago
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