HIPAA Expert (19-00760) – CA – South San Francisco

Applying HIPAA best practices
Document HIPAA compliance standards/procedures for Clients AWS environment

Resource will have the following skillset:
HIPAA expert – principal consultant (senior resource, not intermediate or junior)
Familiar with AWS and able to speak the AWS language
Process development and documentation
Source: Job Diva – Job Listing

Biostatistician with SAS Programming II (19-00759) – MA – Cambridge

Summary:
Consult with Medical Affairs, Health Economics, Value & Access (HEVA), and Real World Evidence Investigators to ensure timely execution to meet evidence needs
Design and conduct analysis for network meta-analysis (NMA) and indirect treatment comparisons (ITC), ensure compliance with best scientific practices and create study reports
Provide statistical expertise to effectively communicate the findings within cross-functional teams including Medical Affairs, HEVA, Clinical Development, Biostatistics, and local affiliates.
Draft or review analytic results for all reports and publications
Ensure validation as per SOP of secondary data analysis protocol
Create statistical sections for study synopses, protocols, or scientific publications
Develop or review statistical inputs and results in submitted materials to external stakeholders, including scientific congress, peer-reviewed journals, regulatory/HTA submissions, core value dossiers etc.
Advise on the methodological decisions and their efficiency to support findings from HEOR studies
Analyze, manage and optimize related databases
Maintain documentation for data, programs, and results
Manage external vendors for the delivery of study protocol, statistical outputs and study reports
Defend statistical positions in interaction with other internal functions or external stakeholders.

Skills: 
Good knowledge of NMA/ITC (mandatory)
Good knowledge of R, Winbugs/OpenBUGS
5 years of relevant experience
Good communication skills
Independence and good organizational capacities.
 
Source: Job Diva – Job Listing

Programmer Analyst (19-00757) – NJ – Woodcliff Lake

Perform Statistical Analyses, review programming and data checking preferably using SAS.
Primarily works with other Statistical programmers on ongoing clinical studies.
Must work well both independently and with team members.
Needs to be able to be on-time with deliverables, and for those deliverables to be of quality.
Works with Statistician or Statistical programmer to assure results are consistent with expectations, and Quality control procedures are followed.
Plans and carefully documents differences between programming results between program developer and Statistical QC programmer. 
Perform statistical analyses and produce outputs for CSR, integration, publication, marketing research, etc.

Confirms that tracking sheets are current for projects, and may also confirm that results are consistent with earlier generated results.
Bachelors degree or above preferred. Mathematics, Statistics or Computer Science degree preferred.
No pharmaceutical experience is required.
Must, however, be detail oriented and process oriented.
Good problem solving, writing, and communication skills required.
Excel, Acrobat, and Word recommended.
XML a plus.
Source: Job Diva – Job Listing

Quality Control Analyst I (19-00755) – TX – Fort Worth

 Duties: MAJOR ACCOUNTABILITIES
Safety/Housekeeping – Keep work areas clean and free of hazards or dangerous conditions

Perform laboratory housekeeping
Follow all laboratory safety regulations, and promote positive safety behaviors
Maintain audit readiness in laboratory

Planning – Ensure supplies and equipment are available to meet test schedules.

Plan and execute testing schedules with moderate supervision

Technical – To perform testing activities that ensure required quality and safety standards are being met for our products.

Perform routine chemical, physical analysis of raw materials, finished goods, products, packaging components per schedule and per standards/SOPs
Collect, calculate, and interpret test results
Enter and report test results
Write and take ownership for SOPs related to testing programs, laboratory operations and/or equipment operation
Perform investigative testing to support laboratory investigations
Perform equipment calibration and maintenance
Conduct peer review of data collected by co-workers

Team – Cooperate and support coworkers to enhance overall capability of the organization.

Participates in problem solving and troubleshooting of laboratory issues
Demonstrated overtime flexibility

Interfaces – Coordinate/support other departments to ensure smooth execution of work.

Possesses moderate communication skills concerning testing and sampling scheduling with other departments and external labs

Skills: 
Minimum:

0-2 years applicable experience in Pharma field or related industry, experience with laboratory requirements and equipment

Experience with chromatography software
Experience with compendial methods
Experience with training other associates

Computer, Microsoft Office
Problem solving
Analytical testing
Deadlines under pressure

Keywords: 
Education: Bachelors of Science
Bachelors of Science in Chemistry or Biochemistry

Source: Job Diva – Job Listing

Business Systems Analyst IV (19-00754) – CA – South San Francisco

The Senior IT Business Systems Analyst will be responsible for working closely with partners from Portfolio Analytics, Market Analysis & Strategy organization and the IT group in order to understand and document strategic drivers and tactical needs to ensure that the implementation teams can provide solutions that meet the business need with the necessary stability, usability, and scalability.
The IT Business Systems Analyst will be supporting projects in the Field Customer Engagement / Advanced Analytics portfolio, experience at SENIOR level is required.
Facilitate workshops – story-boarding workshops, translate story-boarding artifacts into an electronic format and provide input in design sessions
Clearly communicate keeping IT and business partners apprised of developments and requirements, key metrics
Analyze and document current and future business process models
Analyze and document requirements (scope), business rules (use cases)
Analyze and document data requirements (from business needs perspective)
Plan and manage user acceptance test (UAT), create UAT scripts and facilitate UAT; report out on UAT progress and outcomes
Collaborate with business partners, IT Project Managers, User Experience Designers, Solution Architects, Developers & Software Quality Assurance on scope, solutions, constraints and risks
Mentor the teams on UX best practices and oversee the creation of delightful prototypes & dashboards
Perform knowledge transfer to training and communication teams
Support user deployment activities as needed
Lead business stakeholders and other business systems analysts thru the business analysis lifecycle
Work closely with Project Manager, Technical Lead, Developers, Software Quality Assurance Lead to accomplish a successful project delivery, focused on Minimum Viable Product (MVP)
Use Data Analysis tools and strategies to understand data trends and issues, guiding and enabling business users to understand data and data structures and draw key insights for business decisions

¿ 8+ years of experience in advanced analytics roles, exploring and implementing big data solutions with flexible visualization capabilities
¿ Strong knowledge and experience with Pharma sales, claims and other market data preferred
¿ Demonstrated success handling initiatives of high complexity and risk
¿ Demonstrated passion for driving your own self-development and motivation
¿ Ability to multitask, work in a fast paced role and required the art of agility, flexibility and time management
¿ Strong knowledge of advanced analytics, data warehouse modeling and business intelligence concepts
¿ Advanced experience with data visualization and business intelligence software (ETL, Data Integration, Master Data, Qlikview, SAS, Tableau, etc…)
Source: Job Diva – Job Listing

Technical Writer II (19-00753) – CA – South San Francisco

The *** Personalized Healthcare Informatics seeks a talented and motivated Technical Writer/Communication Specialist to support the Imaging team within PHC Network.
Responsibilities:
Draft, proof and finalize documents to support compliance and business process
Understand workflows, document change summaries in clear, understandable redlines without specific guidance
Effectively track and communicate ideas, project goals, results, status and document changes, and drive required escalations
Assisting with preparing scripts, FAQs
Gather business process content, develop and deliver clear communication messages
Proactively respond to communication requests
Preparing ad-hoc presentations
Receive only general instruction and works independently to complete tasks
Create operating instructions, how-to manuals, assembly instructions, and “frequently asked questions” pages
Work with computer hardware engineers, scientists, computer support specialists, and software developers to manage the flow of information

Minimum Required skills:
Bachelor’s degree in Computer Science, Biomedical Engineering, or a similar discipline
Must have at least two years of technical writing experience
Demonstrated superior writing abilities and attention to details
Excellent communication and presentation skills is a must
UX experience is a must
Experience with clinical imaging in multiple therapeutic areas such as Oncology, Ophthalmology, and Neurology would be preferred
Experience with medical image formats (e.g., DICOM, nifti) would be preferred
Desired Qualifications
Journalism, public relations and media writing skills
Experience writing for multicultural and age-specific audiences
Language skills, and writing certification, a plus
Experience writing about health, environment, science and technology, arts, and entertainment a plus
Experience in business development and marketing
Source: Job Diva – Job Listing

Business Systems Analyst IV (19-00752) – CA – South San Francisco

The Senior IT Business Systems Analyst within the Data Services Commercial Data Solutions will be responsible for working closely with partners across the commercial lines of business and within IT to understand strategic drivers and tactical needs to ensure that the team can provide solutions that meet the business need with the necessary stability, usability, and scalability. The Senior IT Business Systems Analyst will be supporting projects in the Data Services commercial alignments, sales processing, and incentive compensation portfolio, and our customer is the *** North America Commercial Sales Organization and Managed Care & Customer Operations.
The IT Business Systems Analyst will be supporting projects in the Field Customer Engagement portfolio, experience at SENIOR level is required.
¿ Facilitate workshops – story-boarding workshops, translate story-boarding artifacts into an electronic format and provide input in design sessions
¿ Clearly communicate keeping IT and business partners apprised of developments and requirements, key metrics
¿ Collaborate with IT Project Managers and the customer. Must build strong relationships with our customers
¿ Analyze and document current and future business process models
¿ Analyze and document requirements (scope), business rules (use cases)
¿ Analyze and document data requirements (from business needs perspective)
¿ Plan and manage user acceptance test (UAT), create UAT scripts and facilitate UAT; report out on UAT progress and outcomes
¿ Collaborate with business partners, IT Project Managers, User Experience Designers, Solution Architects, Developers & Software Quality Assurance on scope, solutions, constraints and risks
¿ Mentor the teams on UX best practices and oversee the creation of delightful prototypes & dashboards
¿ Perform knowledge transfer to training and communication teams
¿ Support user deployment activities as needed
¿ Lead business stakeholders and other business systems analysts thru the business analysis lifecycle
¿ Work closely with Project Manager, Technical Lead, Developers, Software Quality Assurance Lead to accomplish a successful project delivery, focused on Minimum Viable Product (MVP)

¿ 8+ years of experience analyzing business requirements, preferably in a Sales Operations or similar role, exploring and defining solution options and guiding team to a MVP solution
¿ Strong skills in critical thinking and analysis, small and large group facilitation skills
¿ Demonstrated success handling initiatives of high complexity and risk
¿ Ability to multitask, work in a fast paced role and required the art of agility, flexibility and time management
¿ Strong knowledge and experience in Pharma / Biotech / Life Sciences industry with Pharma sales data and Commercial business processes (focus in Sales Operations & Incentive Compensation is preferred
¿ Experience with both Waterfall and Agile methodologies
Source: Job Diva – Job Listing

Compounding Assistant – 3rd Shift (19-00750) – TX – Fort Worth

Duties: Working under the direction of the Production Manager or Supervisor, the incumbent is responsible for supporting the production of quality sterile filtered products to meet the production schedule, which includes cleaning and preparation of processing equipment, maintaining the inventory of supplies and general housekeeping duties. Responsibilities include integrity testing of filters, preparation and sterilization of processing equipment, and coordinating task and schedules within the group and across functional lines. Due to business needs, it may be necessary to work overtime including nights and/or weekends
Skills: Skills include high degree of technical/mechanical aptitude: ability to function in a team environment; ability to operate computerized equipment; ability to function in a fast-paced machine paced environment; excellent interpersonal skill; and the ability to learn aseptic compounding procedures.

Must haves:
Ability to work 3rd Shift 2300-0730 (Tue-Sat)

Must haves:
Ability to follow rules continuously
Very close attention to details
Eager Learner
Ability to manage time well
Ability to work under pressure
Completes the job correctly not just quickly
MUST be able to prioritize tasks and make sound judgment calls
Selft motivated – interested in a growing their career (starting from the middle and working their way up)
*Computer Proficient*

Keywords:
Education: Would like – (30) hours of college credits including two chemistry courses with laboratory (8 hours), and two or more years of external pharmaceutical (manufacturing industry) processing experience (water systems, sanitization, sterilizer, technician), or six months internal  related manufacturing experience. Skills include high degree of mechanical aptitude; ability to function in a team environment; ability to operate computerized equipment; ability to function in a fast-paced machine-paced environment; excellent interpersonal skills; and ability to learn aseptic compounding procedures.

Would like – Bachelor's degree in Science or Engineering and Chemical Compounding Experience.
Skills and Experience:
Required Skills:
ASEPTIC
CHEMISTRY
COMPOUNDING
HOUSEKEEPING
INVENTORY
Additional Skills:
LABORATORY
MANUFACTURING INDUSTRY
MECHANICAL APTITUDE
PROCESSING EXPERIENCE
SANITIZATION
STERILIZATION
WATER SYSTEMS
PRODUCTION SCHEDULE
STERILE

Source: Job Diva – Job Listing

Sr QC Analyst (19-00749) – TX – Fort Worth

Duties: Senior Quality Control Analysts have the following responsibilities:

Perform laboratory activities to support method validation.
Write method validation protocols and reports.
Generate and revise analytical test procedures.

Senior Quality Control Analysts should have the following skill set:

Familiar with current Good Manufacturing Practices and Good Lab Practices.
Familiar with current ICH and USP guidance for analytical method validation.
Familiar with analytical lab equipment and analytical lab techniques (e.g. HPLC, TLC, UV)
The ability to work independently following an approved protocol.
The ability to function in a team environment.
The flexibility to work overtime as required.
The ability to demonstrate creative and innovative thinking to solve analytical problems.
Good technical writing skills and the ability to communicate technical issues to project lead and team.

Skills: Minimum Qualifications:
Bachelors of Science degree in Chemistry or other science
5 years of analytical laboratory experience
3 years analytical method validation experience
Proficient in MS Word and Excel.

Preferred Qualifications:
3 years of experience in a Pharmaceutical manufacturing facility
7 years of analytical laboratory experience
5 years analytical method validation experience
Keywords:
Education: Bachelors of Science degree in Chemistry or other science

Source: Job Diva – Job Listing

Quality Auditor (19-00748) – AZ – Tucson

Responsibilities

Performs business quality system audits – includes audit preparation, conducting audits, writing audit reports, communicating findings to suppliers, business, and stakeholders, and audit follow-up.
Continuously improves the effectiveness of existing quality systems and processes by converting quality system related deficiencies identified through audit findings into improved system and process practices.
Reviews and approves corrective action plans and actions as a result of audit findings.
Effectively executes and/or follows-up on CAPA (Corrective and Preventive Action) Quality System non-conformance or improvements. Performs all activities in full compliance with the quality policies and procedures.
Makes decisions with some level of oversight.
Verifies closure of corrective actions and preventive actions from audits. 
Determines statistical sampling of documents and records to be reviewed during audits.
Prepares audit trend reports.
Supports sites, affiliates, departments, and areas across the client to sustain compliance against applicable standards and regulations.

MUST HAVES:

  1. ISO-13485:2016, MDSAO 2016, FDA certified
  2. ASQ Bio Medical Certification
  3. Heavy on Process audits
  4. SAO/ERP ( ETQ)

 
 
Source: Job Diva – Job Listing

Senior Medical Data Scientist (19-00745) – NJ – Woodcliff Lake

Sr. Medical Data Scientist (Sr. CODER)

Must have at least 10 years of assigning standard terminologies within Clinical Research, familiar with protocol and CRF designs. Adequate knowledge of ICH guidelines.

Ensures verbatim /reported terms are adequately reported and able to assign MedDRA or WHODD terms. Responsible for resolution of PT in SAE reconciliation in collaboration with PDM and PV. Post queries for relevant information. May require to put together search groupings.

Quantitative analysis – Performs a coding and review coding listing from first pass coder in preparation for Study director/Clinical Team review and approval.

Qualitative analysis – Ensures all relevant information is captured in clinical database and provides quality. Ability to evaluate search groupings and perform justification of definition.

Performs all duties according to company policy and regulations and guidance. Performs other duties assigned by the Director or Sr. Manager. No travel required.

QUALIFICATIONS:
– Graduate of adequate health care related course and familiarity with medical terminologies.
– Minimum of 10 years Coding experience within Clinical Research.
– Strong knowledge of ICH guideline
– Knowledge of CODING SYSTEMS, INFORM, J -review is a plus and/or other Clinical trial Systems
– Proficiency on all related regulations, GCP, and Good Clinical DM Practice
– Computer proficiency
– Expertise on use of Microsoft applications, e.g word document, power point, excel
– Strong oral and written communication skills
Source: Job Diva – Job Listing

Quality Engineer – QC Labs (19-00744) – TX – Fort Worth

Duties: Provides mentoring, assistance, support and oversight to Quality Control Laboratories related to validation and qualification change control, calibration, preventive maintenance, root cause investigations and investigation tools, corrective and preventive actions, general process challenges and troubleshooting, as well as execution of risk management processes (risk identification, mitigation, and controls) in compliance with external standards and corporate requirements.

Provide direction and quality oversight in the development, maintenance, and compliance of Quality Systems directly related to Quality Control Laboratory operations.
Lead the quality oversight of larger-scope and more technically complex non-conformance investigations and implementation of corrective and preventive actions.
Perform evaluations of process quality and performance attributes to identify continuous improvement initiatives related to Quality Systems and process control infrastructure to ensure continued sustainability of manufacturing operations and products.
Actively participate in and contribute to routine engineering and manufacturing-based meetings, including presentation of metrics, process challenges, Quality-related initiatives, etc.
Provide a source of consistent quality oversite to engineering lifecycle and change control. This includes; proper matrixed validation approach, attribute inspections, exception handling, proper order of operations, timely closure, appropriate validation paths, reviews of holistic validation packages.
PPC (Product or Process Change)
URS/FRS (User Requirement Specification/Functional Requirement Specification)
SDD (Software Design Document)
ECO (Engineering Change Order)
FAT (Factory Acceptance Test)
Project VMPs (Validation Master Plan)
TMD (Traceability Matrix)
IOQ (Installation Operation Qualification)
PQ (Performance Qualification)

Ensure consistent application of GDP and DI on all documentation.
Provides Quality representation and approvals at the Change Control Board for change requests within respective product areas.
Participate in efforts to streamline change control and Automation Lifecycle Management processes.
Initiate Engineering Change Control (ECO) and Product Process Change (PPC) documentation
Assure adequate product and process controls are in place for identified CTQs. Uses various statistical and non-statistical problem-solving tools as part of analysis.

Skills: Minimum Education / Experience:

Bachelor’s Degree in a scientific technical discipline (preferably engineering, chemistry or microbiology) 5+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, computerized system knowledge, product and process validation, trending, and change control
Microsoft Office Suite with advanced Excel charting experience and statistical analysis capability
Proven problem solving skills, and ability to meet deadlines under pressure
Well organized, with good time-management skills, ability to build rapport

Desired Experience:

Technical understanding of aseptic process or QC laboratory process
Quality Lab Experience
Strong GMP Documentation Skills
Above average understanding of Manufacturing / Production Principles
Strong computer skills, including Microsoft Word, Excel, Power Point, and Project
Excellent organizational skills

Ability to manage multiple priorities
Previous experience with FT-IR, HIAC, microscopic examination, LIMS and track wise preferred.

Keywords:
Education:
Bachelor’s Degree in a scientific technical discipline (preferably engineering, chemistry or microbiology) 5+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, computerized system knowledge, product and process validation, trending, and change control

Source: Job Diva – Job Listing

Laboratory Technician II : Purification Process Development (19-00743) – MA – Framingham

Duties:
Join a team dedicated to supporting purification development and other activities within Bioprocess Development, Biologics Development.

Responsibilities:
– Work independently under general supervision and direction. Work is reviewed for overall adequacy and accuracy.
– Operate complex lab equipment and execute experiments as per written or verbal instructions.
– Prepare buffer solutions or chemicals as needed.
– Prepare and sterilize laboratory equipment for operation.
– May involve work with hazardous materials. On the job training will be provided.
– Progress to performing independent experiments and studies.

A general knowledge of laboratory procedures, purification equipment, and terminology. Should be able handle multiple tasks simultaneously. Able to carry out tasks according to verbal and written instructions. Demonstrated interpersonal skills and effective communication skills required. Demonstrated ability to operate and care for laboratory equipment. Requires physical demands of lifting up to 20-25 pounds.

Education:
Requires a minimum BS degree with 3-6 years of experience in a scientific laboratory setting or MS degree.
Source: Job Diva – Job Listing

Business Systems Analyst III (19-00742) – CA – South San Francisco

As IT Product Manager you will oversee one or multiple products (technology or data solutions) within a Network’s mandate being accountable for the end-to-end product lifecycle and ensuring, in partnering with relevant business stakeholders, that the products are fit-for-purpose.
What you’ll be working on
Co-create product vision and strategy with business partners (e.g. Business Process Owner/Manager, Product Owners) in collaboration with IT experts (e.g. Architects and Business Analysts), external vendors and brings in a value adding Informatics point of view to help continuously improve business processes and solutions. Manage the long-term product roadmap.
Smell opportunities to create additional value and improve business processes and patient outcomes
Manage product lifecycle including release management and decide when enough value has been accrued to warrant a release to the business. In collaboration with Product owners, prioritize product releases considering the optimal flow of throughput from different teams/squads
Determine business criticality and product quality. Define, in collaboration with Delivery Service Manager, service levels, governance and operational support
Lead or coordinate technical discussions and vendor negotiations
Support C-Pod in prioritization and strategic planning, and collaborate with IT Business Partners to meet the needs of the business areas they are partnering with
In collaboration with IT Business Partners, monitor and improve customer and user experience
tifacts into an electronic format and provide input in design sessions
¿ Contribute in roadmap discussions and vendor assessments
¿ Clear communicate keeping IT and the customer apprised of developments and requirements, key metrics
¿ Collaborate with IT Project Managers and the customer. Must build strong relationships with our customers
¿ Analyze and document current and future business process models
¿ Analyze and document requirements (scope), business rules (use cases)
¿ Analyze and document data requirements (from business needs perspective)
¿ Plan user acceptance test (UAT), create UAT scripts and facilitate UAT
¿ Collaborate with customers, IT project managers, Architects, Developers & Software Quality Assurance on solutions and risks
¿ Mentor the teams on UX best practices and oversee the creation of delightful prototypes & dashboards
¿ Perform knowledge transfer to training and communication teams
¿ Support user deployment activities as needed
Lead stakeholders thru the business analysis lifecycle

The ideal candidate
Knows Javascript (must), knows Quickbase and Veeva (desirable)
Has business domain knowledge for the following area(s): Pharma, Biotech
Exhibits the behaviors of a Lean-Agile Leader with a Lean-Agile Mindset
Exhibits intellectual curiosity and integrity and has strong passion to bring value-adding technology to the business.
Entrepreneurial mindset
Source: Job Diva – Job Listing

Medical Reviewer, Pharmacovigilance (19-00741) – NJ – Woodcliff Lake

Job Description
• Provides medical expertise in the review and evaluation of safety information for investigational and marketed products, including evaluation of serious clinical trial adverse events and spontaneous reports of adverse events
• Assesses the relationship between drugs and adverse events
• Evaluates case reportability per local regulatory requirements and meets appropriate timelines for case review
• Participates in the training of the Safety Specialist and Coordinators

Essential Functions
Responsibilities Percent of Time
1. Medical Review of Individual Safety Case Reports: 93%
2. Participates in the training of the Safety Specialists and Coordinators: 5%
3. Administration, Education and miscellaneous: 2%

Scope Measures
• Collaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely Medical Review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory Authorities
• Responsible for the Causality Assessment for both, developmental and marketed product safety for Individual Case Safety Reports

Knowledge/Skills/Abilities Required
• Health care professional degree required – MD, PharmD or Bachelors Degree in Nursing
• 3+ years previous experience in medical review
• Knowledge of disease pathology and physiology, pharmacology and therapeutics
• Knowledge of International and US Regulatory Requirements
• Ability to work effectively in high paced and team environment
• Strong organizational, written and verbal communication skills
• Previous experience using a Pharmacovigilance Database
• Experience with quality assurance activities; attention to detail

***Note: No remote work. 7.5 work day (+1 h lunch break). Start time is between 7:30 – 8:30 am only.
Source: Job Diva – Job Listing