Source: Job Diva – Job Listing
The QC Analyst 1 will carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process and final products.
· Conduct laboratory tests in compliance with established internal Standard Test Methods, compendial methods and vendor partners supplied methods.
· Assist in the development and improvement of written procedures.
· Maintain organized records of tests performed and results obtained. This may include maintaining a computer accessible database for the purpose of tracking and trending analytical data.
· Assist in performing laboratory investigations. Write investigation report as required.
· Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
· Understand and comply with accepted laboratory and safety procedures, including Good Manufacturing Practices.
· Assist in the preparation of analytical data for internal meetings as required.
· Keep laboratory instruments used for testing well maintained.
Skills:
Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc.
Good knowledge of cGMPs and laboratory practices.
Familiar with basic laboratory instruments.
Excellent observation skills and problem solving abilities.
Ability to follow analytical procedures and protocols.
Good laboratory techniques.
Ability to work in a methodical and organized fashion.
Ability to write in a concise, logical fashion.
Ability to manage multiple responsibilities with a high degree of self motivation.
Good oral, written, and interpersonal English communication skills.
Ability to effectively utilize scientific information resources within the assigned area of responsibility.
Keywords:
Education:
BS degree in Chemistry from an accredited college or university or equivalent experience
1 year of relevant hands-on pharmaceutical laboratory experience.
Skills and Experience:
Required Skills:
CGMPS
DATABASE
QUALITY ASSURANCE/QUALITY CONTROL
SAFETY PROCEDURES
LABORATORY
Additional Skills:
PROBLEM SOLVING
QUALITY ASSURANCE
QUALITY CONTROL
SAMPLING
WORD
CHEMISTRY
DATABASES
LOCKOUT/TAGOUT
MICROSOFT WORD
Source: Job Diva – Job Listing
Duties:
Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision.
Plans and prioritizes concurrent experimental procedures. Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Works under active supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy.
Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters.
Experience: 3 to 6 years
Biologic Drug Product Development (BDPD) is responsible for the late stage biopharmaceutical formulation/fill finish process development, process scale up, and technology transfers to manufacturing or CMO. This multi-disciplinary team interacts intensively with many functional groups, including early formulation, process development, analytical, regulatory, clinical, and commercial manufacturing, for the pipeline product development. BDPD has also provided technical support for commercial manufacturing, clinical trial material production, manufacturing deviation investigation, process tech transfer/ validation, and regulatory response.
The incumbent will be responsible for preparing buffer and formulation solutions, conducting protein sample analysis using different analytical techniques, including HPLC, Microflow imaging, HIAC, spectrophotometry, NIR, etc.
The associate will be responsible for study design of frozen bulk process development, such as freeze thaw, compatibility, and stability experiments. Experimentation may include scale down modelling of frozen bulk systems. Additional studies may include fill finish process development (e.g. mixing, filtration, effect of fluid flow, and lyophilization). Other responsibilities will include presentation of study results both inside and outside group.
The candidate has to be self-motivated, with three or more years of experience, with a good understanding of protein biochemistry and biophysics.
Source: Job Diva – Job Listing
• Provide Validation/QC guidance in regards to clinical data programming tasks for multiple studies.
• Provide Validation/QC support for study team members from the study start up to the end.
• Review/Provide Validation QC support for the database, data transfer, SDTM mapping specs to ensure that documents and specification are consistent and comply with internal/industry standards.
• Perform data reconciliation, data quality control, and program SAS edit checks..
• Review/generate/validate electronic submission deliverables such as SDTM datasets,
• Perform Quality Testing/User Acceptance Testing of EDC systems.
• Support quality control and quality audit of deliverables.
• Contribute to activities for validation/QC and implementation including standard reporting systems, SAS macro utility programs and associated tools.
Responsible for maintaining a formal quality control process in accordance with Clients standard operating procedures and Good Clinical Practice.
Perform validation & quality control to ensure all program development activities within the Oncology Business Group IODS follow established processes, and ensure proper documentation and timely posting into the TMF as required. This includes but not limited to the validation and QC support of clinical database design, reports & listings programs, SDTM conversion and related programming, post production changes, and implementation of programming tools within the IODS group
Essential Function
1. Work closely with the data management team members to coordinate and execute validation and QC activities
2. Evaluate system/study level validation/QC activities along with drafting of supporting documentation
3. Oversee testing and validation/QC activities of existing clinical studies
4. Collaborate with Regulatory and Publishing for submission activities
Job Qualifications
Bachelor or higher degree in Computer Science, Engineering or related field;
Minimum 5 years’ experience in the areas of software development life cycle supporting a GCP environment, clinical database set up in the pharmaceutical or related industries, clinical data management process and a practical understanding of GCP validation requirements
Aware of FDA, EMA, MHRA and ICH regulations and guidelines governing the conduct of clinical trails
Understanding of EDC systems, such as Medidata Rave, Inform, OC-RDC, IXRS (IRT), or other similar applications
Excellent oral and written communication skills; good “people” skills, good organizational skills to effectively guide multiple resources involved in various projects.
Excellent team player; able to work under pressure, handle situation involving different functions and teams
Source: Job Diva – Job Listing
As a member of the Data Analytics group, candidate will be responsible for supporting the Marketing and Field groups, delivering actionable insights through data analysis and reporting initiatives. This position will provide expertise in the analysis of all Client Oncology / Neurology brand & field information as well as manage Oncology / Neurology brand internal reporting operations. This position will be responsible for partnering with Client’s Oncology / Neurology Marketing teams to provide value added analytical insights critical to the success of Client’s business. Reporting functions will largely entail collaborating with Operations, IC, and Field Leadership to ensure all reports/ad-hocs meet business requirements. This position will also be responsible for managing contractors/consultants as part of the Commercial Analytics structure.
KEY RESPONSIBILITIES:
• Lead data analytics projects and inquiries for the Neurology & Oncology Groups
• Generate actionable information and insights which will enable better business decisions across Client
• Analyze Neurology and Oncology data, create / modify dashboards
• Maintain / consolidate and develop new reports/ad-hocs to monitor Neurology and Oncology business units
• Support key stakeholders with data consultation, gathering and analytics
• Work with various stakeholders to identify data mining needs and provide required data solutions / analysis / deliverables
• Maintain SOP documentation, gather and write and execute business requirements
• Lead Third Party Agreements and Vendor Management
• Coordinates with the Operations team to address the quarterly target change feedback received from the field teams
Job Qualifications – Knowledge/Skills/Abilities Required:
• Bachelor’s Degree (BS/BA) in an analytic discipline – engineering, mathematics, statistics, economics, etc. Master’s degree in a similar field or an MBA preferred
• 8 years Pharmaceutical industry knowledge (Sales Operations, Sales, Marketing)
• 4+ years Project/Vendor Management experience
• Excellent writing, training, and presentation skills, and demonstrated ability to influence others
• Strong Knowledge of third party pharmaceutical sales/script/call details data (DDD, NSP, Xponent, DataView, longitudinal patient data, claims data, etc.)
• Experience in working with IT staff as well as the ability to understand and guide technical work pertaining to data storage/organization, data access, etc.
• Strong programming (SAS / SQL), data analysis skills, plus curiosity, enthusiasm and commitment to growing these skills further
• MS Excel, PowerPoint and BI tools (MicroStrategy, Business Objects, etc.) -Intermediate to Advanced user
• Prior consulting experience a plus
• Finely tuned attention to detail
• Excellent organizational skills and the ability to balance multiple demands
• Excellent communication and interpersonal skills
• Proven and successful team player
• Self-starter with interest and ability to work both independently and highly collaboratively
• Excellent presentation skills
• Summarize, analyze, prepare, present various reports and findings in a clear/concise manner
Source: Job Diva – Job Listing
Strong technical skills and Oncology experiences supporting submissions are required.
Main duties/responsibilities:
1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
2. SDTM and ADaM technical knowledge required. In addition, knowledge of agency requirements including ICH, FDA, and other guidances is strongly recommended. Knowledge of current FDA submission process (Define.xml, etc.) is strongly recommended. Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development. Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents. Good understanding with different phases of clinical trials, protocols, and CRF designs.
3. Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers.
4. Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process.
Required:
Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred. Strong educational background is expected.
• Minimum 8 years’ experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment. Lead Programmer experience is expected.
• Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment. Understanding of submission-related activities and experience with agency-related requirements expected. Define.XML knowledge and familiarity with a submission process is preferred.
• Oncology and in-depth ADaM programming required. Submission support with compliance is expected. (this text is what was sent to you earlier and should be ok.)
Skills and aptitude required:
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Knowledge of SDTM and ADaM standards.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.
Source: Job Diva – Job Listing
This position is an in-house position with an up to 50% travel component. This position will help manage a team of field-based contract CRAs for a multi-site study and will be the primary field CRA for some clinical sites.
This position reports to the Sr. Director of Clinical Affairs.
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
-Must have SAP Plant Maintenance, Manufacturing and Leonardo Configuration Experience.
-Subject Matter Expert for SAP Plant Maintenance and MRO Projects
-Lead the identification of a pilot opportunity for SAP Leonardo in the manufacturing and plant maintenance area. Lead the subsequent development and implementation of a Leonardo pilot.
-Direct engagement and customer facing in all business processes
-Participate in Design, Create Functional Specs, Test Scripts, Testing, Cutover
-Active support of migration and transformation projects
-Major Enhancements and Support.
Key Qualifications:
-BS or equivalent experience
-4+ years PM Functional Lead consulting experience
-2+ years in production support
-Experience in SAP Leonardo solutions for the Plant Maintenance/Manufacturing domain. Includes experience with Internet of Things (IoT), Sensor interfaces and Predictive Analytics.
-Proficiency in MRO (Spares Planning and Procurement)
-Proficiency in Cross Application Integration with PP, MM, Finance, Procurement functionality
-Proficient in Master data management and upload programs like LSMW
-Exposure to Syclo Mobile, Portal & Fiori Applications
Source: Job Diva – Job Listing
This position supports the PHC Informatics – Imaging Group requirements process for in-house developed or purchased IT systems to meet functional area business needs. The BSA is expected to monitoring deliverables for quality and implementing Software Development Lifecycle (SDLC) process improvements while providing continuity through adherence to Pharma Informatics Project Management Methodology (PMM) process as appropriate.
Responsibilities:
Planning early stage project efforts; specifically, requirements gathering methods based on user community work style, requirements assessment and scoping, and project initiation and funding
Supporting the successful implementation of technical solutions by providing business process analysis design, strategic vision, best practice research, detailed requirements definition alignment, user-centric functional design, vendor evaluations, systems assessments, and user acceptance testing facilitation.
The ability to lead small to medium sized projects in accordance with IT project management methodologies
Collaborating with Project Managers, Architects, Engineers, Developers, and Designers on scope, solutions, constraints, and risks
Analyzing, documenting, and advising on current and future business process models
Analyzing and documenting task models that accurately represent a cross-section of a particular end-user community
Planning and facilitating workshops and end-user working sessions intended to surface requirements and validate designs
Analyzing and documenting high-level requirements (scope)
Analyzing and documenting detailed functional requirements and business rules (use cases)
Analyzing and documenting data requirements (from business needs perspective)
Qualifications Requirements
5+ years business systems analysis and support experience with various types of Software Development Life Cycle methodologies in an enterprise IT environment
Must have excellent knowledge of healthcare interoperability standards includes DICOM, and HL7
Proven project management experience
Strong presentation and meeting facilitation skills
Strong analytical and problem-solving skills
Be able to work in ambiguity
Advanced English language skills, including Listening, Reading, Writing, and Speaking
Demonstrated focus on customer service, team development and on-time delivery
Ability to rapidly understand business requirements and communicate business expectations to cross-functional technology development teams.
Demonstrated ability to quickly learn the business in unfamiliar areas
Facilitate and/or support customers in UAT planning and execution
Drive resolution of business or systems issues.
Source: Job Diva – Job Listing
Global Technical Development (PTD) is an organization integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops innovative technical solutions to bridge early-stage, late-stage and commercial product needs.
PTDO Informatics Team is responsible for a broad range of IT services and support across small and large molecule technical development, device development, analytical sciences, business operations and supply chain in PTD. We provide lab information management systems, data management solutions and web applications to support PTD functions.
POSITION
Contract
Reporting to the Principal Systems Manager TD Global Head of Informatics, the position will be accountable for business analysis, software upgrades, informatics operational support, defining business requirements for new/enhanced functionality, maintenance of the system configuration and associated documentation, and implementation support. The incumbent will work closely with Roche Global Informatics to deliver quality services. He/she must be customer-service oriented, sensitive to the IT needs of the client groups.
RESPONSIBILITIES
Under the supervision and direction of IT Manager execute on IT/Informatics support requests. Assist in new request/project scope analysis, preparation of proposals, vendor and solution evaluation.
Work closely with scientific staff to understand their information management needs and collaborate with informatics/ infrastructure personnel to deliver on those IT/informatics needs.
Experience in handling multiple requests/projects that require interacting with user community and technical teams.
Create direct channels of communication to software and application developers that get the job done without constant managerial interjection
Demonstrated experience in providing IT support and solution implementation in scientific domain.
Develop scope documents, determine and document User/ Business requirements/Narrative Use Cases, User Stories for business processes, produce end user documentation and training materials.
Act as a coordinator to track, plan and deliver on IT tasks. Provide regular project progress and status to IT management and business stakeholder/interested parties.
REQUIREMENTS
Five years providing informatics solutions to business problems, developing and managing IT systems with a focus on IT solution delivery, quality IT support and client services in biotech, pharmaceuticals, medical device, diagnostic, management consulting or other relevant industry.
Individual with excellent customer relationship management skills with an IT delivery service-minded attitude.
Demonstrated experience collaborating effectively across multiple IT functions and customer groups.
Demonstrated experience managing lab software for scientific domains including managing software and hardware requirements, software configuration, knowledge of networks, and lab instrument installation.
Working knowledge of software platforms used in GMP Quality Control Laboratories, pharmaceutical manufacturing, applicable FDA guidance, and 21 CFR.
The successful candidate will be a strong team player, proactive, outgoing and detail-oriented with excellent organizational & follow up, problem-solving and written/verbal communication skills.
Source: Job Diva – Job Listing
Job title: Manager, Global Clinical Trial Transparency, MDC
Main purpose of the job:
To oversee the end-to-end operations for clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide (disclosure operations process). To ensure disclosure operations, vendor and study teams perform activities in accordance with Client’s Policy for Clinical Trial Data Access and the Disclosure of Clinical Trial Information and applicable regulations.
:
Will include but will not be limited to the following activities:
• Performing/coordinating all activities for the registration and results posting to clinicaltrials.gov, EudraCT, and similar databases worldwide in compliance with policy and procedures, and applicable regulations
• Working closely with the internal Client team and vendor to ensure they understand their roles and responsibilities related to Client’s disclosure obligations
• Works with the internal Client team to ensure the source information is provided for disclosure activities in a timely manner
• Working closely with the vendor to ensure that the studies get registered and results get posted to major registries in compliance with policy, procedures, and applicable regulations.
• Disclosure Tracking Database: ensure Client’s disclosure information are maintained and in compliance with relevant procedures
• Process and Training: maintain Client process documents and training materials in line with regulation updates and acquired knowledge as required.
• Raising awareness of clinical trial disclosure and its changing requirements within the company globally as required.
• Supporting other clinical transparency activities within GCTT as required
• Work will be mainly office-based in an open plan environment with flexibility to work from home, adhering to the company rules.
• Software/computer systems used mainly include:
o MS Office, especially MS Excel
o Sharepoint
o Document Management System (Documentum)
o Client Clinical Trials tracking database
o Data entry portals for publicly accessible registries
o Vendor platforms and databases
• The position does not currently have line management responsibilities
• Internal: close collaboration with Client departments worldwide managing studies, such as clinical operations and local affiliates (EU, US, Japan, China, other Asian countries)
• External: close collaboration with an external vendor (tasked with tracking, summary writing, and posting of information)
• Education to B.Sc. level or equivalent
• Good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
• Demonstrated experience in the pharmaceutical industry, with exposure to least one of the following areas;
o Clinical trial transparency
o Clinical trial disclosure
o Medical writing
• Understanding of clinical development within the pharmaceutical industry.
• Experience with study registration and results disclosure on clinicaltrials.gov
• Experience of supporting and managing tasks / projects, by establishing strong relationships and coordinating those resources (internal and external) to achieve deliverables in compliance with process and / or contract.
• Experience of working with different software packages and platforms.
• Track record of driving and successfully completing time-sensitive projects across multiple departments
• Strong verbal and written communication skills that enable effective global meeting facilitation, makes difficult concepts easy to understand, and demonstrates ability to articulate difficult issues.
• Ability to quickly become a SME for software packages, IT platforms, databases etc. that support GCTT operations.
• Team player able to form strong (internal and external) relationships, demonstrating an ability to influence/persuade others.
• Ability to handle multiple tasks and/or projects simultaneously.
• Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries
• Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency.
• Flexible and proactive.
• Eye for detail.
Source: Job Diva – Job Listing
Summary: *** is seeking an entry level Stock Plan Administrator to provide full back-up capabilities for the Stock Plan Administrator (SPA) and to support the equity team. Will perform support functions around our employee stock purchases; auditing enrollment, contributions and monthly deduction changes; plan and communicate open enrollment and training. Will prepare and review annual tax rate compliance reports, aggregate and maintain state and ex-US tax information for use in stock transactions and restricted stock unit releases. Provide accounting support around compensation tracking on events such as grants, vesting, exercises and releases, reporting/data exchange with ex-US payroll provider. Organize participant educational communications, material and training regarding our stock plans, tax liability, or other related training within the organization. Job Responsibilities: Develop, maintain, and analyze tax rate records*** ESPP and stock plan support, employee communication and customer service. Requires strong verbal and written communication skills, attention to detail, and critical thinking. Ability to work independently and manage one’s time. Knowledge of equity compensation, procedures and regulations as related to accounting. Previous experience with computer applications, such as Microsoft Word, Excel and PowerPoint, and any other related accounting software. Knowledge of the Sarbanes-Oxley Act of 2002 and internal controls, Biotech/Pharmaceutical/High-tech industry experience desired. Education/Experience: Associates degree in paralegal studies, business administration or related discipline required. 1-2 years public company paralegal and/or equity accounting experience required.
Source: Job Diva – Job Listing
Performs environmental monitoring of plant utilities and production clean zones using particle counters, contact plates and microbial air samplers.
Performs routine and non-routine microbiological testing such as water bioburden and media growth promotion; Gram staining and microbial identifications.
Performs enumeration and characterization of microorganisms recovered from samples.
Assist with data analysis, troubleshooting and problem solving.
Perform testing according to Standard Operating Procedures (SOPs) and/or GMPs.
Works under direct supervision from management on routine tasks, and with general instructions on new assignments
Works on problems of diverse scope where analysis of data requires a review of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
May support validation activities, troubleshooting and SOP revisions.
Maintains accurate and well-organized laboratory records, notebooks and/or worksheets.
Performs other duties as may be required or necessary.
Follow all hazardous materials and hazardous waste management regulations and guidelines.
Ensure compliance with GMP/HSE regulations, *** policies, procedures and standards as appropriate for the role.
Champion a Quality Culture and ensure a safe working environment.
As appropriate, responsible for implementation of, compliance to, and governance of practices and principles
Required Skills:
1 year or more experience in the pharmaceutical industry working in a GMP environment is preferred
· Must have a demonstrated working knowledge of scientific principles.
· Strong oral and written communication skills are required.
Previous hands-on practical laboratory experience is required.
Strong organizational skills are required.
Must have demonstrated problem solving abilities.
Knowledge of FDA regulations and cGMP’s for drugs and device are a plus.
Knowledge of USP and EP tests, such as microbial enumeration tests and bacterial endotoxin test is desirable.
Source: Job Diva – Job Listing
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