Duties:
Job Description:
The Clinical Research Coordinator I assist in the daily activities of clinical research studies, obtains informed consent; collects, maintains and organizes study information.
Primary Duties and Responsibilities:
1. Collects and records study data. Inputs all information into database
2. Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
3. Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
4. Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews.
5. Secures, delivers and ships clinical specimens as required by the protocol.
6. Responsible for organizing and preparing for monitoring visits.
7. Coordination and management of clinical trials including communication with Sponsors
8. Performs other related duties.
Skills:
Excellent written and oral communication skills
Exceptional attention to detail and accuracy
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
QUALIFICATIONS AND COMPETENCIES
EDUCATION/ EXPERIENCE
Appropriate level will be determined based upon experience and knowledge.
TECHNICAL KNOWLEDGE, SKILLS, AND CAPABILITIES
The requirements listed below are representative of the knowledge, skills, and/or abilities required to perform each essential duty satisfactorily.
Technical Capabilities – Must also be proficient with the following:
Time Management – Ability to work within a fast-paced, deadline oriented environment with minimal supervision. Must be well organized with a high attention to detail and accuracy.
Computer Skills – Must have intermediate skills in Microsoft Word, Outlook, Excel and PowerPoint.
Project Management – Interest in developing, communicating and coordinating projects. Strong ability to multi-task and prioritize multiple projects.
Reasoning/Analytical Ability – Ability to define problems, collect & analyzes data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
GENERAL CORE COMPETENCIES
Effective Communication – Ability to read and comprehend instructions, policies and procedures. Strong written and verbal communication skills; Interest in learning to present complex data to groups of internal and external customers in a clear and concise manner. Ability to articulate, in writing, detailed concepts. Ability to collaborate with other departments to complete projects on time.
Customer Service – Ability to provide excellent customer service to both internal and external clients.
Teamwork – Ability to collaborate in a team environment; seek regular feedback and contribute in team meetings. Provide back-up to other team members as necessary.
Results Orientation – Be accountable for producing an accurate, timely and quality work product.
Operational Excellence – Collaborate with others to identify efficiencies and process improvements. Embrace change and the focus on continuous improvement.
PHYSICAL DEMANDS
Source: Job Diva – Job Listing
Job Summary:
This role specifically:
• Helps maintain the health of the currently released BIOVIA Laboratory Execution System(LES)/Electronic Laboratory System (ELN) system in the production environment, ensuring the system performs its intended functions accurately and reliably.
• Provides end-to-end support for tickets requiring system change (requirements gathering, documentation updates, development, system configuration, validation protocol/script development to validation execution)
• Follows existing client support processes, procedures, and systems consistent to organizational compliance practices and relevant regulatory requirements (i.e., 21CFR Part 11) such that the system remains in a controlled, validated state
• Will take LES/ELN support calls from the user community through phone, email, and face-to-face to answer application usage questions, investigate application behavior, and determine if the issue is a:
1) System use, system behavior, or documentation issue requiring additional training to provide understanding of system functionality, and/or updates to documentation to resolve
2) System administration issue – user privileges, paths, product specification and analysis , directory maintenance , background/scheduler server, log files
3) System functionality enhancement change request – functionality not in system, system not behaving as desire, new functional addition requests
4) Technology, hardware, desktop, network issue or failure
5) Business concern requiring a management or technical decision which cannot be resolved by changing system
For the above issue types, the expectation will be to resolve or follow processes to resolve 1 through 4, and to notify the proper individuals to resolve 5.
• will enter support 'tickets' into Client support systems for tracking, prioritization , and management to closure
• Assists in the establishment and application of best practices in support management activities, both in the support systems used to track and manage support requests, and in making recommendations to improve the actual processes used to execute the Client support life-cycle, from user requests for change to deployment of that change.
• Assists in the establishment and application of best practices in change management, including how changes are approved and implemented, and how objects are tracked, managed and promoted.
• Communicates to Client leadership regarding system status, concerns, and ideas for continued improvement of the Lab Systems implementation.
• Follows Client configuration management and promotion processes between environments (dev, test, prod) to keep instances in sync as required.
Has good customer support and communication skills.
Source: Job Diva – Job Listing
Please note: Candidates with a recent Masters or PHD in Bio Engineering or Bio Medical Engineering have done VERY well in the past. Please focus your search on this type of degree!
Work with Cataract and Vitreoretinal R&D groups on development projects resulting in achieving R&Ds project goals. Tasks include supplier evaluation/qualification, component qualification, managing prototype builds, assuring assembly process is developed and documented, assure BOMs are entered and maintained correctly, assure product costs are accurate and rolled, conduct Production Readiness Review.
Support Product transfer projects either into or out of plant
Identify and qualify alternate materials and/or components for either risk mitigation or because of obsolescence.
Maintain adequate supply of purchased components through contact with Procurement and the Suppliers. Qualify tooling and equipment as required to assure capacity.
Address any component or product quality issue assigned, determining root cause and completing corrective action.
Address any requests from other departments related to BOMs and components.
Manage product labeling.
Identify and qualify Cost Improvements.
– Communicates clearly.
– Speaks/writes English.
– Works well with others.
– Has leadership capability and is self starter.
– Ability to learn and retain many complex processes quickly.
– Focuses on detail/quality.
– Experience writing technical protocols/reports.
– Ability to use MS Word/Excel/Powerpoint/Project.
– Root cause analysis experience to determinine cause of issues.
– Experience in Medical Device industry – Manufacturing / Design / Quality Engineering fields- preferred.
Source: Job Diva – Job Listing
Duties:
The primary responsibilities of the Labeling Compliance Specialist include supporting the implementation and operation of labeling systems including document management and milestone tracking, and performing quality/compliance processes including compliance tracking, reporting and proofreading of Company Core Data Sheets (CCDS), US labeling and artwork, and EU product information. The Labeling Compliance specialist will also perform a variety of other labeling tasks which may include, but are not limited to: maintenance of distribution lists, management of tracking spreadsheets, labeling systems management, management of drug listing and establishment information in SPL.
Skills:
Detail oriented
A high level of skill in written English, including spelling, grammar and punctuation
Experience with labeling systems and technologies
Experience with proofreading of pharmaceutical labeling and document comparison software
Familiarity with medical terminology
Ability to work independently and meet deadlines.
2-5 years of pharma industry related experience.
Source: Job Diva – Job Listing
Key responsibilities
The incumbent will join a dynamic multi-disciplinary multi-modality drug product development team, with responsibilities that span from formulation development to fill finish of clinical, commercial and life-cycle stage assets within the Biologics/GMU Drug Product Development and Manufacturing.
The successful candidate would be required to:
o Develop experimental plans and execute studies to assess physicochemical stability of non-viral, viral vectors- and cell-based therapeutics
o Assist in process development studies for manufacturing unit operations for injectable dosage forms (e.g. freeze-thaw, mixing, filtration, filling, lyophilization etc.).
Assist in developing new technologies in the areas of polymer-based drug delivery technologies
o Work closely and independently with counterparts from other functional areas to deliver on CMC milestones
o Generate, document and compile data for team and senior management discussions and draft development reports
o Mentor junior staff as required
Preferred Qualifications
Solid understanding and practical experience in drug product formulation and process development of non-viral gene therapeutics: formulation development of lipid nanoparticles, liposomes and polymer conjugates for nucleic acid delivery, container closure selection, stability studies, in-use studies and process development of liquid, frozen, and lyophilized drug product. Theoretical knowledge and hands-on experience in analytical techniques: Fluorescence based nucleic acid quantitation assays (e.g. Ribogreen assay), HPLC/UPLC, capillary electrophoresis, gel electrophoresis, DLS, zeta-potential, DSC, DSF, UV, CD, Cryo-TEM.
Experience in formulation and process development of viral vector-and cell-based therapeutics is a plus. Experience in cell culture, flow-cytometry, qPCR, ITA, plate-based potency assay is a plus.
Basic understanding of statistical data analysis. Good written and verbal communication skills.
Education:
BS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 6 plus years of relevant experience or MS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 2 plus years of relevant experience
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
Responsible for conducting manufacturing laboratory experimentation and other scientific activities to support commercial product lines. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within the department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follow company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator for deviation or discrepancy events (Lab Exceptions or OOS investigations). Troubleshoots problems and institutes corrective action. Designs a wide range of experimental protocols. Executes bench experiments; makes detailed and general observations and analyzes data. Prepares technical reports, summaries and quantitative analyses. Maintains complete and accurate records. Normally receives general directions on routine and new assignments. Identifies and implements improvements to work processes and laboratory environment. Monitors work to ensure quality, and continuously promote Quality First Time.
Knows a wide range of experimental techniques and is skilled in their applications. Skilled with use of word processing, spreadsheets, graphical and presentation software applications. Experienced in Root Cause Analysis and technical writing.
Experience: 4 or more years relevant job experience. Exceptions for internal high potential and high performing employees not meeting minimum qualifications will be taken into consideration and must be approved through Human Resources.
Source: Job Diva – Job Listing
This is a technical contributor and developer role which requires knowledge of web architecture, web applications development, UI/UX, API design, security, and continuous integration & deployment. You will build new functionality, increase scale, and deliver quality work against technical and schedule challenges in an agile environment while following strong software design and process principles to meet our customer demands. You will be working with talented engineers on cutting-edge technologies while continually growing your skills as an engineer.
We are looking for someone who can work well in a startup within an organization and can bring flexibility, speed, and quality to our team. You should have a solid background in the fundamentals of software development as well as a deep understanding of best practices in various languages and technologies. Additionally, you should be passionate about and take great personal pride in building cool interfaces for other developers to use.
If you are an expert at designing, developing, and deploying web services, and like to be challenged, this is the perfect opportunity for you to help define this exciting new field for Dolby.
Key requirements & attributes for successful applicants include:
** URGENT NEED
** FULLY REMOTE but should be willing to work West Coast hours if needed.
Source: Job Diva – Job Listing
Skills
Able to work independently
Builds highly collaborative relationships with other internal and external teams to provision the IPP team with data needed to do their jobs
Patient and persistent
Strong written communication skills
Excel and power-point power user
Salesforce, SAP Business Intelligence/SQL
Knowledge of analysis software (i.e. SPSS, SAS) helpful
Ability to train personnel
Requirements:
8+ years of business analysis skills and project management experience.
Demonstrated leadership & people management skills
Bachelor’s degree in Business, Finance, Computer Science or Engineering. Graduate (or equivalent experience) degree preferred.
Experience working in a team-oriented, collaborative environment, ability to influence
Excellent communication, leadership, problem solving and analytical skills
Advanced knowledge of Excel, PowerPoint, Access. Knowledge of SQL preferred.
Experience in managing data reporting, consolidation and analysis
Strong initiative and ability to manage multiple projects independently, with minimal direction, and with solid follow through
Exceptional written, oral, and presentation communication abilities
Experience in technology industry is a plus
Knowledge in licensee audit processes is a plus
Strong ability to mediate complex cross functional issues and work with others in fast paced, dynamic environment
Source: Job Diva – Job Listing
This is a technical contributor role which requires deep knowledge of web architecture, infrastructure, tooling, security, testing and continuous integration & delivery. You will build and improve tooling, deployment pipelines, increase scale, and make existing processes more efficient. You will deliver quality work against technical and schedule challenges in an agile environment while following strong software design and process principles to meet our internal and external customers’ demands. You will be working with talented engineers on cutting-edge technologies while continually growing your skills as an engineer.
We are looking for an experienced engineer who can take initiative, work independently and be a self-starter, in a dynamic startup environment within an organization and can bring flexibility, speed and expertise to our team. You should have a solid background in the fundamentals of DevOps, automation, testing, web development and deployment as well as a deep understanding of best practices in various languages and technologies. Additionally, you should be passionate about and take great personal pride in building tools for other developers to use in order improve their efficiency.
If you are an expert at designing, developing, and deploying web services, and like to be challenged, this is the perfect opportunity for you to help define this exciting new field for Dolby.
Key requirements & attributes for successful applicants include:
**URGENT NEED
** FULLY REMOTE but should be willing to work West Coast hours if needed.
Source: Job Diva – Job Listing
Instructional Design:
– Perform Training Needs Assessment for newly identified training requirements.
– Determine optimum source for instructional design
– Coordinate handover of training needs to selected course developer
– Maintain status of courseware under development Technology Integration
– Fully leverage the use of available learning and web-based technology to ensure the right solution is delivered to the right learner at the right time.
– Partner with internal and external resources to maintain website and central learning portal to enable easy access to tools, information and resources that facilitate learning across the organization
Management System
– Partner with departments and subject matter experts to improve on-the-job and campaign-specific training activities and tools.
– .Stay abreast of the training industry (including adult learning, instructional design, e-learning, and performance improvement) in order to provide clients with learning leadership, being fully aware of the most current learning trends and tools available.
Training Delivery
– Organize training delivery
– Communicate upcoming courses Training Effectiveness Measurement
– Develop, implement and maintain ongoing evaluation strategy
– Develop means of measuring the effectiveness and efficiency of training programs and monitor their ongoing impact
– Collaborate with Instructional Designers, training specialists, and Trainers across PROP as appropriate to ensure resources and best practices are being consistently leveraged and results reported.Instructional Design:
– Perform Training Needs Assessment for newly identified training requirements.
– Determine optimum source for instructional design
– Coordinate handover of training needs to selected course developer
– Maintain status of courseware under development Technology Integration
– Fully leverage the use of available learning and web-based technology to ensure the right solution is delivered to the right learner at the right time.
– Partner with internal and external resources to maintain website and central learning portal to enable easy access to tools, information and resources that facilitate learning across the organization Management System – Partner with departments and subject matter experts to improve on-the-job and campaign-specific training activities and tools. – .Stay abreast of the training industry (including adult learning, instructional design, e-learning, and performance improvement) in order to provide clients with learning leadership, being fully aware of the most current learning trends and tools available. Training Delivery – Organize training delivery – Communicate upcoming courses Training Effectiveness Measurement – Develop, implement and maintain ongoing evaluation strategy – Develop means of measuring the effectiveness and efficiency of training programs and monitor their ongoing impact – Collaborate with Instructional Designers, training specialists, and Trainers across Pharma Technical Operations as appropriate to ensure resources and best practices are being consistently leveraged and results reported.
Skills
Team-oriented approach; able to quickly and consistently establish rapport; ability to collaborate effectively with clients, team members and partners. Strong relationship builder. Minimum 3 years experience in a training, learning and development role. Ability to formulate a formal project plan and track projects against it. Strong planning and organizational skills and the ability to manage multiple priorities at the same time. Working knowledge of Good Manufacturing Practices (GMP) and Standard Operation Procedures.
Education
BA or BS degree required
Source: Job Diva – Job Listing
Source: Job Diva – Job Listing
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