Medical Information Specialist (20-00061) – NJ – Woodcliff Lake

Job Summary:
The Medical Information Specialist is responsible for meeting the medical information needs of external customers and internal business partners as it relates to the companys products. He/she will contribute to the development of high-quality Medical Information deliverables within the team and will be a visible member of the department by collaborating cross-functionally to meet Medical Affairs objectives. This includes but is not limited to:

Utilize clinical and scientific expertise to respond to medical information inquiries from health care professionals, patient/consumers, field staff , internal business partners and other customers
Monitor scientific literature for potential adverse event reports; report findings to Product Safety within established timeframes
Research and conduct detailed analyses of the scientific literature for Client marketed products, investigational compounds, competitor products/compounds, and related disease states. Contribute to communication, reporting and storage of findings
Contribute to the development and revision of standard medical responses, AMCP dossiers, Q & A documents and other medical information resources
Ensure medical accuracy of Clients advertising, promotional and scientific materials as part of Copy Review Committee and Product Medical Review Committee, in collaboration with Medical Information Managers and Medical Directors
Assist with and contribute to other Scientific Communications and Medical Affairs activities

Responsibilities Percent of Time
Respond to unsolicited medical inquiries from healthcare professionals, patients/consumers, field staff and other internal business partners, regarding Client marketed products, investigational compounds, clinical trials and other product information 50%
Utilize literature evaluation skills to monitor scientific literature for potential adverse event reports; Research and conduct detailed analyses of the scientific literature for Client marketed products, investigational compounds, competitor products/compounds, and related disease states for use by Scientific Communications, Medical Affairs and other internal business partners. Contribute to communication, reporting and storage of literature findings 10%
Contribute to the development and revision of standard medical responses, AMCP dossiers, Q & A documents, and other medical information resources 20%
Support the Medical Information Managers and Medical Directors with CRC and PMRC processes by reviewing advertising, promotional and scientific materials for medical accuracy. 10%
Assist with and contribute to other Scientific Communications and Medical Affairs activities, training and performance improvement initiatives 10%

Scope Measures
The Medical Information Specialist provides clinical and technical expertise necessary for the completion of departmental programs and projects. The Specialist is required to have frequent contact with cross-functional departments and external customers and is a key contributor in the completion of programs and projects. Errors made by the Specialist may result in program delays, expenditure of resources and in the case of literature monitoring for potential adverse events, failure to meet regulatory requirements. The Specialists activities are done under some direction from the Medical Information Managers and/or Associate Director.

Knowledge/Skills/Abilities Required
Biomedical training and education (RPh, RN PharmD preferred).
Superior literature database search skills
Excellent written and verbal communication skills with experience in medical writing
Superior customer service skills
Knowledge of U.S. regulatory standards related to pharmaceutical manufacturers communications and dissemination of medical information, clinical trial processes and drug approval processes.
Minimum of 1 year of experience in pharmaceutical industry-based medical information or related discipline
Familiarity with Microsoft Office software and customer management software.
Source: Job Diva – Job Listing

Biostatistician with SAS Programming III (20-00060) – NJ – Bridgewater

Duties:
To perform tasks under the guidance of project lead or CMS departmental principals on analytic design and statistical analytic planning, coordinate real world database management, and data warehouse construction or maintenance; to develop documentations of analytic plans, prepare for statistical concept communications and be able to advise on analytic strategies and recommend methodological solutions on complex analytic topics; to lead and perform statistical analysis, modeling, reporting, analytic interpretations, and slide development; to develop SAS macro libraries to standardize disease identification, cohort constructions, mapping of healthcare resource utilization and expenditures to standard metrics for product value propositions; to construct drug coding systems to support database activities for key therapeutic R;D and brand LCM activities, and establish and maintain a repository of the coding systems for therapeutic medications, diagnostic or surgical procedures and drug delivery systems ; to establish and main variety of disease identification and composite comorbidity assessment tools and algorithms; to conduct analytic quality assurance procedures; to provide timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications; to provide analytic support for internal and external communications and statistical interpretations of data under the guidance of departmental methodological principals.
 
Responsibilities:
� Develop statistical analytic plans, statistical expertise and data management techniques and skills � Manage real world database operations, analytic programming and statistical modeling activities � Assist project lead or departmental principals in study design, power calculation, CRF construction, analytic operations and reporting for retrospective and prospective studies � Assist project lead or departmental principals in analytic/computing resource planning,, work flow management and prioritization, and related logistic coordination � Prepare communication materials on analytic projects including processes, data, analytic findings for internal and external functional groups within or outside of CMS � Prepare slide decks for congress or manuscript submissions or internal or external communications � Plan and initiate analytic projects using the real world databases or clinical trial data warehouse in support of the CMS initiatives � Provides consultation for all CMS groups on research methodology and statistical or analytic issues � Vendor Management � Database licensing and maintenance � Analytic process formulation and standardization � Potentially supervising team of analytic and programming support.  

Skills: 
Good knowledge of pharmaceutical clinical development, together with Late Phase experience.
Demonstrated strong interpersonal and communication skills

Education: 
PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience
 
Source: Job Diva – Job Listing

Biostatistician with SAS Programming III (20-00059) – NJ – Bridgewater

Duties:
To lead statistical aspects of clinical project development under the guidance of head. 
To represent Biostatistics in the project team, to provide strategic and statistical supports to the projects, to design clinical trials and to propose and implement innovative designs whenever appropriate.

Skills:
Highly proficient in statistical theory and applications with more than 6 years of pharmaceutical experiences in clinical development from Phase 1 to Phase 4. 
Familiar with current innovative statistical methodologies such as adaptive clinical trial design, Bayesian methodology, historical data utilization, etc.
Excellent oral and written communication skills and great player in the team setting.

Education:
Ph.D. in Biostatistics or Statistics
 
Source: Job Diva – Job Listing

SAS Admin (20-00058) – MA – Boston

7+ years of experience, 2+ hands-on experience as SAS-Admin
Strong communication skills
Ability to learn other skills quickly. Customer would like this candidate to be cross-skilled and hence this requirement.
Profound knowledge of working in clinical support area (familiarity with clinical activities, biostats, reporting, data managers etc)

Source: Job Diva – Job Listing

Senior Clinical Database Analyst (20-00057) – NJ – Woodcliff Lake

Summary:
Responsible for providing support for clinical studies within designated IxRS systems according to Oncology’s processes and standards.
Accountable for providing IxRS support in study setup, documentation review, and implementation of the clinical studies for UAT and production releases.
The incumbent responsibilities include IxRS integration, study maintenance, user support, testing, collaboration with study team members – vendor support, and decommissioning of study IxRS.
Provides technical expertise to the clinical team members and to the developers in the areas of clinical database design, and related technical programming based on Protocol design.

Responsibilities:
• Provides technical expertise to the clinical study team members in the areas of IxRS design for Oncology studies, and related documents.
• Draft study specific IxRS UAT Scripts and maintain Global/Standard IxRS Scripts Library.
• Ensure that all the study designs follow the IxRS standards.
• Provide support for IxRS set up for Oncology studies and related standards, user support & management.
• Ensure IRT processes are compliant with GCP & GMP guidelines and principles, 21CFR Part 11, and applicable regulations.
• Develop IxRS External data transfer specifications to the vendor for data transfer and test for accuracy.
• Monitor and collaborate with the vendor for trial deployment, coordinate postproduction changes, IxRS decommissioning, user & and submission related support.
• Develop standard and Ad-hoc listings to support Data Management and other clinical areas related to EDC studies for data cleaning, data reviewing, and trial monitoring functions
 
Requirements:
Bachelor’s degree (or foreign equivalent degree) in Biotechnology, Computer Science, Engineering, Mathematics, Biological Science or related field with 3 -5 years of experience, or Master’s degree with 2 -3 years of experience in Data Operations methods and processes in industry setting.
Knowledge of the IVRS/IWRS/IRT systems, Clinical Data Management Systems, InForm 6.x, Central Designer 2.x, Central Coding, relational Databases, Oracle, SQL, COGNOS, MedDRA, WHODRUG dictionaries, CDISC, and CDASH is a plus
Source: Job Diva – Job Listing

Manufacturing Tech II (20-00054) – PA – Exton

Sr. Manufacturing/Manufacturing Associate

Job Summary
The Sr. Manufacturing/Manufacturing Associate will be responsible for assisting in the development of commercialization systems including end user testing of SAP modules and creation of procedures and work instructions for launch of the new SAP Commercial system at the Exton site. Post implementation, the Associate will support floor execution of manufacturing campaigns and assisting the training of other operations staff to use new commercial SAP system.

Essential Functions
Assist with the development, review, and revision of all associated controlled documents needed to utilize the SAP system as an End User including End-User Standard Operating Procedures, Work Instructions, Job Aids, etc.
Provide Development phase (DEV environment) support and feedback for all SAP elements related to Support Operations (buffer/media, and weigh/dispense)
Provide User Acceptance Testing (UAT) execution/support resource during the SAP Qualification (Q) phase
Assist with the orientation and training of additional Support Operations or Biologics staff for rolling out routine use of the qualified SAP system for production campaigns
Assist with the initial SAP end-to-end use and troubleshooting during initial GMP batch production as an End User
Contribute to the floor execution of GMP batch production in support operations or upstream/downstream processing (buffer/media prep, etc.) with appropriate technical skills, techniques, and experiences

Requirements
Minimum of 3 years experience in buffer/media or upstream/downstream processing at a pharmaceutical or biotechnology company
Minimum of 3 years End-User experience and/or knowledge in SAP Process systems as used in a regulated manufacturing environment (not IT SAP role)
Knowledgeable in the lifecycle execution of Process Orders on the shop floor including:
o Staging of materials / components from the main warehouse to Production Storage Locations on the shop floor.
o Consumption of materials / components to executable Process Orders.
o Confirmation of Labor Hours against active Process Orders.
o Yield of Process Orders to inventory.
Assist in trouble-shooting of Process Order-related problems on the shop floor including missing parts, due date management and material consumption deficiencies.
Monitor inventory in buffer/media preparation and weigh/dispense suites or inventory in Upstream/Downstream suites and assist in inventory reconciliation activities
Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Support or Biologics Operations.
Source: Job Diva – Job Listing

Quality Assurance Associate-Pharma (20-00053) – MA – Burlington

Manage, write, investigate, review and approve deviations, CCR's CAPA's, product complaints. Manage metrics. Help out in other areas of quality assurance as required.

Quals–
Understanding of Good Manufacturing and Laboratory Practices, FDA regulations, SOPs, and current compliance standards. Attention to detail. Experience in Root cause analysis (5 WHY's, Fishbone) Good technical writing skills This position requires a B.S. degree and 2- 4 years experience in pharmaceutical manufacturing or 4-8 years of equivalent experience
Source: Job Diva – Job Listing

Systems Specialist I (20-00052) – CA – South San Francisco

is looking to acquire a Full-time Laboratory Automation Engineer at our South San Francisco campus in Northern California for a minimum 3-6 month contract (contract is renewable). The ideal candidate is eager, enthusiastic, team-oriented, a keen problem-solver and has a hybrid background in the Life Sciences and Computational Sciences.
The candidate will report directly to the Departmental Automation Lead and collaboratively build/harmonize automated methods on a Hamilton STAR robot.

Basic lab experience (using pipettes, following standard operating procedures or instructions to conduct experiments)
Some coding experience/coursework (Visual BASIC, C#, JAVA, C++, Python, JAVAScript, etc.)
Well-rounded understanding of technology, machinery and engineering
1-3 years experience programming Hamilton Robots
Source: Job Diva – Job Listing

Quality Control Analyst I (20-00051) – TX – Fort Worth

Safety/Housekeeping
Keep working areas clean and free of hazards or dangerous conditions
Perform daily housekeeping of lab work areas
Follow all safety regulations and promote positive behaviors
Planning
Ensure supplies and equipment are available to meet schedules
Carry out work assignments as defined by production schedule
Plan, schedule, prepare and maintain microbiological culture media samples and equipment.
Technical
Strictly adhere to Current Good Manufacturing Practices (cGMP), Current Good Documentation Practices (cGDP), and Standard Operating Procedures and report all discrepancies immediately.
Sanitize/sterilize equipment, facilities and materials.
Complete required documentation (MBRs, SOPs, checklists, etc) in accordance with cGMP and cGDP.
Maintain aseptic personnel certification and practice good aseptic techniques in performance of duties.
Aseptically collect and process microbial samples for assigned test areas (critical utility systems, aseptic processing environments and personnel, sterility, bioburden, BET, LAL, biological indicators, microbial identifications, etc.)
Perform routine analysis of raw materials, finished goods, products, packaging components, complaints, investigations per schedule and per standards/SOPs.
Collect and analyze critical utility and/or environmental samples.
Collect, calculate, and interpret test results.
Perform activities that ensure required quality and safety standards are being met for our products
Record, retrieve and report data through LIMS of assay results
Document analytical testing in accordance with site good documentation practices
Review and approve autoclave reports and logbook entries
Support laboratory investigation activities as needed
Support active management of laboratory inventory including standards, media and supplies
Team
Cooperate and support coworkers to enhance overall capability of organization
Participate in problem solving and troubleshooting of common laboratory issues
Support training needs of team members and work cohesively with coworkers
Coordinate activities with other departments which involve Microbiology support
Communicate effectively with production, maintenance, warehouse, and other groups as necessary

Educational background BSc in Microbiology or Biology
Source: Job Diva – Job Listing

Senior Systems Analyst (20-00050) – NJ – Woodcliff Lake

Sr. Systems Analyst (Project Management)
To support Oncology Data Operation team by developing and implementing new methodology to create and maintain tools with proper security on Unix and Windows servers. Responsible for providing support for clinical studies within designated IxRS systems according to Oncologys processes and standards. The responsibilities includes Clinical study maintenance, user support, testing, collaboration with study team members vendor support, and decommissioning of study. Evaluate , Analyze and implement new software application and provide technical support. Manage and contribute to departmental and corporate projects. Effectively manage project plans with timelines and communication. Perform risk based analysis and come up with optimum options with justification and implementation plans. Integration of various in-house , third party and cloud based application.

Minimum seven (7) years of System Analysis, project management and programming support experience
Experience in integration of various application like InForm, IxRS, Central Designer, Central Coding, Medidata RAVE, IRT, RBM, PACE, Pinnacle 21, JReview, MS Sharepoint, sFTP with vendors etc.
Knowledge and experience using multiple languages/platforms for programming including:
1. SQL programming
2. .Net
3. PERL script
4. VB scripts
Demonstrated ability to efficiently design and produce new custom tool for internal use.
Should be able to program and administer batch job schedules in enterprise production scheduler
Knowledge of cloud base server and application operation.
Experience in evaluating, installing and configuring custom and off-the- shelves software.
Experience in evaluating new software and tools, based on business requirement.
Should be able to analyze system and business requirement, and create documentation.
Experience in perform IQ/OQ/PQ/UAT of application software.
Strong background in software version control and change control management procedures
Sound understanding of Interface between files systems and servers on various networks.
Strong oral and written communication skill
Source: Job Diva – Job Listing

Senior Engineer, Data Pipeline (20-00045) – CA – Santa Clara

Job Description

looking for an experienced Data Pipeline Engineer. The hire will be responsible for expanding and optimizing our data and data pipeline architecture, as well as optimizing data flow and collection for cross functional teams. The ideal candidate is an experienced data pipeline builder and data wrangler who enjoys optimizing data systems and building them from the ground up. The Data Engineer will support our software developers, data analysts and data scientists on data initiatives and will ensure optimal data delivery architecture is consistent throughout ongoing projects. They must be self-directed and comfortable supporting the data needs of multiple teams, systems and products. The right candidate will be excited by the prospect of optimizing or even re-designing our company’s data architecture to support our next generation of products and data initiatives.

DUTIES AND RESPONSIBILITIES: Essential Functions

Create and maintain optimal data pipeline architecture,

Assemble large, complex data sets that meet functional / non-functional business requirements.

Identify, design, and implement internal process improvements: automating manual processes, optimizing data delivery, re-designing infrastructure for greater scalability, etc.

Build the infrastructure required for optimal extraction, transformation, and loading of data from a wide variety of data sources using Hive and Elasticsearch.

Build analytics tools that utilize the data pipeline to provide actionable insights into customer acquisition, operational efficiency and other key business performance metrics.

Work with stakeholders including the Executive, Product, Data and Design teams to assist with data-related technical issues and support their data infrastructure needs.

Create data tools for analytics and data scientist team members that assist them in building and optimizing our product into an innovative industry leader.

Work with data and analytics experts to strive for greater functionality in our data systems.

Education:

Minimum:Bachelor’s Degree

Preferred:Master’s Degree

Major/Discipline:Computer Science/Math

Relevant Work Experience

Minimum:3+ year of Data Engineer

Preferred:5+ years Data Engineer

Skills & Abilities: (Technical or General)

Minimum Requirements:

  • Knowledge of data analysis techniques
  • Experience with big data tools: Hive, Spark, Elasticsearch etc.
  • Experience with object-oriented/object function scripting languages: Python, Java, etc.
  • Strong communications skills
  • Ability to work well as part of a team

Preferred:

  • Working Query knowledge and experience working with NoSQL databases (Hive, Elasticsearch).
  • Experience building and optimizing ‘big data’ data pipelines, architectures and data sets.
  • Experience performing root cause analysis on internal and external data and processes to answer specific business questions and identify opportunities for improvement.
  • Strong analytic skills related to working with unstructured datasets.
  • Build processes supporting data transformation, data structures, metadata, dependency and workload management.
  • Experience supporting and working with cross-functional teams in a dynamic environment.
  • Experience with big data tools: Hadoop, Spark, etc.
  • Experience with NoSQL databases, including Hive, Elasticsearch.
  • Experience with object-oriented/object function scripting languages: Python, Java, etc.

Source: Job Diva – Job Listing

Biostatistician with SAS Programming I (20-00044) – NJ – Bridgewater

Duties:           
To perform tasks under the guidance of project lead or departmental principals on analytic design and statistical analytic planning, coordinate real world database management, and data warehouse construction or maintenance; to develop documentations of analytic plans, prepare for statistical concept communications and be able to advise on analytic strategies and recommend methodological solutions on complex analytic topics; to lead and perform statistical analysis, modeling, reporting, analytic interpretations, and slide development; to develop SAS macro libraries to standardize disease identification, cohort constructions, mapping of healthcare resource utilization and expenditures to standard metrics for product value propositions; to construct drug coding systems to support database activities for key therapeutic R;D and brand LCM activities, and establish and maintain a repository of the coding systems for therapeutic medications, diagnostic or surgical procedures and drug delivery systems ; to establish and main variety of disease identification and composite comorbidity assessment tools and algorithms; to conduct analytic quality assurance procedures; to provide timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications; to provide analytic support for internal and external communications and statistical interpretations of data under the guidance of departmental methodological principals.
 
Responsibilities:
Develop statistical analytic plans, statistical expertise and data management techniques and skills
Manage real world database operations, analytic programming and statistical modeling activities
Assist project lead or departmental principals in study design, power calculation, CRF construction, analytic operations and reporting for retrospective and prospective studies
Assist project lead or departmental principals in analytic/computing resource planning,, work flow management and prioritization, and related logistic coordination
Prepare communication materials on analytic projects including processes, data, analytic findings for internal and external functional groups within or outside of dept.
Prepare slide decks for congress or manuscript submissions or internal or external communications
Plan and initiate analytic projects using the real world databases or clinical trial data warehouse in support of the dept. initiatives
Provides consultation for all dept. groups on research methodology and statistical or analytic issues
Vendor Management
Database licensing and maintenance
Analytic process formulation and standardization
Potentially supervising team of analytic and programming support
 
Experience: 0 to 3 years.
 
Skills:
Proficient with SAS or R
Have experience working on Phase 2, 3 or 4 clinical trials
 
Education:    
Master or PhD in statistics or biostatistics
Source: Job Diva – Job Listing

Scientist I — US02B0109 : Biochemistry and Bioanalytics US02 (20-00043) – MA – Cambridge

We are seeking a highly motivated and skilled research associate to join our Target Engagement team within the Proteomics Department of Translational Sciences division of *** Research Platform. A successful candidate will be responsible for preparing biological samples, maintaining cell cultures, developing varies biochemical and cellular assays to quantify target proteins and to study the mechanism of action of Protac molecules. In addition, he or she will apply bioanalytical and biophysical tools to characterize target proteins. Candidate is expected to record experimental results in electronic notebook, make sound judgment on scientific merits and seek advice when appropriate, and present and defend his/her data at internal project meetings.

Candidate should have a good understanding on protein biochemistry. He or she should have experiences in developing biochemical assays (such as fluorescence based assays) and know how to maintain cell cultures and conduct cellular based assays. Candidate should have strong working knowledge in standard scientific graphing and curve fitting software used for data analysis such as GraphPad Prism.
At least 2 years experience in Biochemistry
Source: Job Diva – Job Listing

Registration Information Management (20-00042) – NJ – East Hanover

As a member of the Registration Information Management (RIM) Team, responsible to support implementation of processes and procedures to ensure sustained compliance, at the global, regional and local level, with Health Authority regulations and internal *** expectations regarding the capture and management of the registration information for the global *** portfolio of products in current and upcoming systems.
Major Accountabilities
With guidance, directs and monitors HQ and CO compliance with internal procedures governing registration information management activities at the global, regional and local level. Provides training as needed
Expert in RA Systems and related tools that support registration information management processes worldwide
Provides counsel and guidance to RA CO colleagues regarding their accountability in the registration information process
Supports the regulatory strategy and contributes to the implementation of NovaRIM in collaboration with business owner and IT through e.g. data cleaning supervision on legacy systems, authoring of project-related documents etc.
Key Performance Indicators
Supports the achievement of consistent and sustainable performance against worldwide HA expectations and internal *** procedures governing registration information management:
Demonstration of a strong Quality and Compliance mindset
Strong project management, teamwork and customer focus
Contribution to business and quality benefits
Ability to establish good working relationships within RA and with other key stakeholders
Superior communication, facilitation, negotiation, and problem resolution skills
Demonstrated ability to continuously improve operations
Ability to influence change

2-4 years experience mainly in a regulatory environment & closely related areas (eg; Clinical Development, GCP, QA)
Must have knowledge of global regulatory requirements
Understands and able to assist RA in understanding compliance and quality drivers from a global perspective,
Country regulatory/pharmaceutical experience from outside Europe or US
Use of IT systems
Experience and ability to work in matrix cross-functional environment
Excellent verbal and written communication skills.
Proven negotiation skills
Demonstrated ability as a creative thinker
Logical and methodical, with attention to details
Source: Job Diva – Job Listing