Manufacturing Transfer Quality Engineer (Contract) (19-00451) – CA

Description: Supports the transfer or process and product. Must be able to work independently and have a quality mind set. Must have actual hands on experience. Must be able to execute and drive quality deliverable. Able to perform TMV, IQ, OQ, and PQ. Must have strong QE background with some project leadership experience

Source: Job Diva – Job Listing

Documentation Specialist (19-00450) – NC – Raleigh

Job Summary:
Accountable for Document Control function at the Raleigh site. Act as subject matter expert for Client’s electronic document management system (eDMS). This includes controlling documents throughout the lifecycle, training and assisting system users, reviewing, approving, and executing system change control and validation documentation, and identifying and resolving compliance issues. Facilitate off-site storage and retrieval of departmental records. Assist with creating and revising departmental record retention schedules. Perform internal audits of documents and records and manage the periodic review process.

Exercises judgment in cooperation with Quality Systems management to oversee and manage a controlled document process for Raleigh site and several departments. Control over 700 documents for at least 18 departments. Provide support and system training for 130 + users at five sites as needed.

Essential Functions:
1. Business owner for eDMS (Controlled Documents)
2. Review and approve eDMS change control and validation documentation in cooperation with QS management
3. Control documents and provide end user support and training for eDMS
4. Provide records management support to Raleigh Quality Operations
5. Ad hoc projects and tasks
6. Perform internal document and record audits.
7. Manage periodic review process.

Requirements:
• High school diploma or GED
• 5+ years of document control/administration experience in the pharmaceutical/biotech industry, preferably in QA or QC.
• Strong oral and written communication skills
• Ability to interpret and apply GMPs, relevant laws, guidance and directives
• Attention to detail
• Ability to coordinate activities with multiple functional groups with a sense of urgency and exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining solutions.
• Strong computer skills (preferably MS Office, Adobe Acrobat Pro, WebEx, Java, and Documentum)
• Ability to lift 30 pounds
Source: Job Diva – Job Listing

Clinical Research Associate I (19-00449) – AZ – Tucson

POSITION SUMMARY:
Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by Company, Medical Affairs. Works closely with study manager and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).  Works closely with project managers, Medical Managers, and Directors with project planning, implementation, and facilitating Medical Affairs various types of non-registrational projects.
  
Site Management & Monitoring:

  • Conducts in-house, and may independently perform on-site monitoring in accordance with Company Standard Operating Procedures, ICH GCP guidelines and Regulations.
  • Participates in assessing study risks.
  • Communicates on behalf of the study manager with investigators and site staff.
  • Prepares study performance reports and provides input into study budgets.
  • Manage study supply inventory and shipping.
  • Conduct and assess site readiness and assist in creating site monitoring plans
  • Work across multiple project teams, indications, and differing study designs
  • Assist in the creation of study materials (CRFS, operation manuals, protocols, etc.).
  • Assist in the creation of departmental operating procedures and tracking systems.

Study Implementation:

  • Study training presentations for investigators and site staff.
  • Study supply ordering and shipping.
  • Investigational product release, labeling, accountability at study sites.
  • Site Readiness and Site Monitoring Plans.
  • Assay transfer and assay qualification activities.
  • Study records including paper and eTMF and electronic clinical trial management system
  • Site qualification, site initiation, routine monitoring and close out visits and reports.
  • Document compilation for clinical study reports and document archive activities.
  • Data management activities including user acceptance testing, data entry, and data verification as needed. 

Formal Training/Education:
Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.
 
Experience:

  • 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience. 
  • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred.
  • A background in biomedical/healthcare services with laboratory experience preferred.
  • Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
  • Excellent writing and verbal communication skills.
  • Well organized and detail oriented.
  • Impeccable record keeping and filing skills.
  • Excellent time management skills.
  • Ability to give presentations and teach others.
  • Ability to work effectively in a team, and also work independently on assigned tasks
  • Ability to complete intermittent overnight travel up to 30%.

Source: Job Diva – Job Listing

Lab Assistant (19-00448) – AZ – Tucson

POSITION SUMMARY: Maintains laboratory instruments and equipment on a daily, monthly, and quarterly basis. Prepares reagents and monitors instruments for bulk reagent levels. Orders and stocks office and laboratory supplies and equipment.
ESSENTIAL FUNCTIONS:
Performs daily, monthly and quarterly instrument and equipment maintenance and cleaning tasks.
Monitors and maintains logs for all equipment and instruments.
Monitors and prepares bulk reagents daily.
Orders office and laboratory materials.
Executes and monitors purchase orders as requested.
Supports and maintains slide scanners.
May provide administrative or logistical support on scientific projects.
May perform other duties as required or assigned.
Will position work with chemicals? If yes, what room(s)? -Yes, but primarily Ventana advanced staining bulk reagents in 2075/ 2079 (non-hazardous). Position may be required to change xylene/ alcohols in coverslipping instruments, but training and PPE will be provided.

Knowledge, Skills, and Abilities:
Able to work independently.
Strong communication skills, verbal and written.
Attention to detail in written instructions and documentation.
Basic computer skills in Word, Excel and Outlook.
Manager's Must Haves:
Ability to multitask and transition between different tasks (ex. reagent replenishment to assisting with instrument maintenance)
Experience with inventory management preferred
Works independently but is part of a team delivering key services to product development teams
Position may require lifting up to 44 lb.
Experience with the basic suite of office tools (ex. google calendars, excel)
Previous experience in a lab setting preferred
Mobility. This position will require movement between several labs in one building on campus each day
Source: Job Diva – Job Listing

Clinical Research Associate II – Denver or New York (19-00416) – NJ – East Hanover

Multiple Openings for CRA II – REMOTE POSITIONS covering either Denver, CO or New York Area – MUST be local to one of the regions

Duties:
The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.
The Senior CRA is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Trial Monitoring strategy

Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
Allocation, initiation and conduct of trials
Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial

Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
Facilitates the preparation and collection of site and country level documents
Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements

Skills:                                         
Minimum of 3 years experience in site monitoring
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)

Basic project management skills to support in CSM activities.
Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings. 
A minimum of 50% overnight travel may be required.

Advanced communication skills, ability to influence others.
Advanced data accuracy: Ability to work focused with a great attention to detail.
Ability to manage sites independently
Source: Job Diva – Job Listing

Clinical Research Associate II (19-00412) – NJ – East Hanover

The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.

Duties:
Trial Monitoring strategy
Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
Allocation, initiation and conduct of trials
•             Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
•             Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and  procedures
•             Facilitates the preparation and collection of site and country level documents
•             Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
•             Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
•             Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
•             Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
•             Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
•             Attends onboarding-, disease indication and project specific training and general CRA training as required
•             Documents monitoring activities appropriately following Client standards
•             Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed
•             Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
•             Monitors studies as per current legislations, ICH/GCP
•             Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.(ADIS, DBL)
•             Identifies issues at sites; resolves issues and escalate as appropriate
•             Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry
•             Ensures the site Investigator Folder is up to date. Is responsible for collecting essential documents from site and accountable to keep sTMF(s) current.
•             Participates in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement
•             Supports the implementation of innovative processes and technologies
 
Education:                         

  • Degree in scientific or healthcare discipline.

Experience/Competencies:                                       
•             Minimum of 3 years experience in site monitoring
•             Excellent knowledge of the drug development process specifically clinical trial/research
•             Knowledge of international standards (GCP/ICH, FDA, EMEA)
•             Ability to manage multiple priorities and manage time efficiently.
•             Basic project management skills
 
Source: Job Diva – Job Listing

Senior Project Manager (19-00410) – NJ – Woodcliff Lake

Commercial Launch Project Manager

Essential Duties
• Manage up to two Commercial Launch projects for the [US market] ensuring timely completion of tasks and overall completion. Position will require the capability to communicate and coordinate with the outside alliance partner
• Working with functional experts, create and maintain the cross functional commercial launch readiness and launch plan (including marketing, operations, sales, market access, external communications, medical affairs, manufacturing, etc.), map key activities, functional milestones and timing, identify risk and lead development of mitigation/contingency plans necessary to deliver the project in full, on time and on budget
• Becomes the point of contact for the day to day management of the launch plan. Monitor project performance and proactively anticipate issues impacting the launch, working with the functional groups to develop contingency plans and communicate risks and contingencies to management to ensure the project critical path is managed Develop and maintain the launch planning calendar that identifies critical decision points, team events and milestones
• Summarize and communicate routine launch readiness updates across internal functions, commercial leadership, and as needed to collaborators and agencies
• Organize and facilitate launch team meeting topics/agendas, manage team members and meeting attendees based on agreed upon structure, take meeting minutes, track meeting decisions and issues, and, follow-up action items
• Communicate program and project plans to ensure a common understanding by stakeholders and team members. Take action/escalation to remove barriers in a timely and effective manner. Report progress and ensure full visibility and support
• Challenge the product launch team to constantly improve decision making to ensure best possible launch for products
• Manage the critical path of the project and key project risks
• Participates in cross-functional teams in support of continuous improvement and other management objectives
• Ensure materials and activities comply with applicable regulations, guidance documents, SOPs and policies

Qualifications: Knowledge / Skills / Abilities
• BS or BA in a related field
• At least 6 years Life Science industry experience, minimum 2 years of prior launch experience and an understanding of drug launch processes, functions, and the required interrelated steps
• Knowledge of pharmaceutical development including hands-on experience in the successful planning and execution relating to the launch of commercial pharmaceutical products
• Project management and organizational skills. Experience in the use and understanding of the critical value of technology in planning, managing milestones and integrating interdependencies within an organization. MS project experience required. PMP certification a plus.
• Critical thinking and analytic skills along with strategic decision making capability—ability to see big picture, identify essence through high complexity and form solutions and actions in a timely fashion
• Outstanding stakeholder management skills (e.g.,. building partnerships, influence, negotiation, gaining commitment and driving accountability)
• Resilience, flexibility and comfort with ambiguity
• Ability to work in a virtual setting/across time zones, (i.e., making effective use of communication tools (Skype, WebEx, and video conferencing, etc.)
• Strong planning and organizational skills and the ability to lead teams to necessary outcomes
• Ability to effectively work with teams and promote collaborations in a matrix organization.
• Excellent verbal and written communication skills, ability to interact with all levels of management within the organization and to external business contacts.
• Proficient with MS Office products and other technology tools
Source: Job Diva – Job Listing

Scientific Associate II (19-00409) – MA – Cambridge

Work independently in supporting senior group scientists on their projects as well as Client delivery technologies projects (time split between the two activities).  Design, plan, and perform experiments in order to test hypotheses and advance understanding of fundamental scientific principles. Interpret and report results.
 
In detail, perform basic physchem characterization of new molecular entities, such as use of analytical techniques to confirm physical form, measurement of solubility and evaluation of chemical and physical stability.  Develop formulations to support in vivo studies.  Perform feasibility studies to assess Client delivery technologies for various internal projects.  Carry out basic laboratory housekeeping activities such as preparation of buffers and mobile phases. 

Major Activities
  1. With minimal oversight from lead project scientist, design and perform scientific experiments.
  2. Interpret results, evaluate data, draw relevant conclusions and write reports.
  3. Report and present results internally.
  4. Utilize complex laboratory tools and equipment.
  5. Maintain infrastructure, equipment and required investments.
  6. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members.
Education (minimum/desirable): Minimum: BS with at least 1-3 years of laboratory experience. 
Desired: MS or PhD focused in pharmaceutical sciences/drug delivery
Languages Proficient in English (oral and written)
Experience (desirable/required):
 
 
 

  1. Knowledge of laboratory and technical tools, such as thermal techniques, X-Ray powder diffraction and particle size analysis required.
  2. Proficient in utilization of special tools and equipment, lab automation tools and specialized facilities e.g., containment and sterile labs, and analytical tools such as LC-MS, etc.
  3. Good knowledge of software and computer tools.
  4. Very good communication skills. Good presentation skills and scientific/technical writing skills.
  5. Experience with making nano and micro particle formulations desired

 

 
Source: Job Diva – Job Listing

QC Associate I – Chemist (19-00408) – CA – San Carlos

Job Responsibilties:
Executes testing of all active substances, raw materials (excipients) and finished dosage forms according to defined procedures under close direction
Participates in the self-directed work team in prioritizing, scheduling and resource allocation in order to maintain efficient workflow to assure completion of schedules, fully synchronized with the Process Oriented Unit
Support deviation investigations including OOS/OOE/OOT
Participates in laboratory operational improvement projects
Ensure that all activities are performed according to the local Quality System and SOP’s, as well as national and local regulations
Demonstrate behaviors and positive attitudes in line with Quality Assurance values.
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.
Champion a Quality Culture and ensure a safe working environment.
As appropriate, responsible for implementation of, compliance to, and governance of practices and principles specifically prescribed to this role by the  Operational Standards for Supply Chain Excellence .
Demonstrates and role models the values and behaviors
Employees may be required to inspect products or packaging, or any other task where near visual and/or color acuity is necessary. Possess visual acuity no worse than 20/20 uncorrected or correctable to 20/20 with combined eyes.· Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job unction.
Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds).
Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function.
Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function
Eligibility:
1 year or more of work experience in pharmaceutical and commercial environment is preferred.
Previous hands-on practical laboratory experience is required.
Must have a demonstrated working knowledge of scientific principles.
Must be able to demonstrate basic decision-making skills.
Must possess good oral and written communication skills.
Must be able to demonstrate sound judgment.
Must have demonstrated problem solving abilities.
Strong organizational skills are required.
Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus.
Experience working in an FDA regulated environment is highly desired.
Must be willing to work as part of a team and demonstrate good interpersonal skills.
Source: Job Diva – Job Listing

Biostat Programmer (19-00402) – NJ – Woodcliff Lake

There are 2 openings – one requires experience with PHASE 1 and the other one requires  experience with PHASE II and III 

Duties:
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: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests. 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. Working closely with statistician, and other statistical programmers to generate and QC TLG outputs; review data specifications to ensure accuracy, quality and soundness of statistical programming algorithm; coordinate internal resource utilization to generate activities metrics for management review. 
3. Providing input in developing specifications of analysis datasets, validation plans, and other related documents, reviewing data submission package including define file, and data reviewer’s guide documents. 
4. Working independently to accomplish tasks and goals defined by supervisor and bringing in new ideas to improve the programming process. 

Qualifications Required:
• Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred. 
• Minimum 6+ years of experience in SAS programming for phase I clinical trials in a pharmaceutical/CRO environment. FDA submission experience preferred. 
• Some project experience in a pharmaceutical/CRO programming environment or demonstrated leadership in a clinical pharmaceutical/CRO environment. 
• Submission experience a plus. 
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. 
• Experience in CDISC data standards, e.g. SDTM and ADaM 
• Proven experience with Unix and Windows operating systems. 
• Understanding of the software development life cycle. 
• Understanding of FDA guidelines. 
 
Source: Job Diva – Job Listing

Senior Engineer (JL=16) (19-00383) – CA – Mountain View

Description:
Contractor – AI Developer
Mountain View, CA
Full Job Description
As an AI developer in the *** AI Acceleration Lab, candidate will be responsible for developing AI middleware and framework capabilities and create, measure and optimize parallel AI model training environments consisting of CPUs and accelerators connected by a high-speed data network, collaborating with AI developers, performance engineers and AI application engineers to create an integrated end-to-end AI environment centered on high performance and ease of use.
Responsibilities:
– Analyze and assess current AI implementations
– Conceptualize, architect and implement parallel AI training deployments
– Use high-performance industry standard protocols such as MPI to build highly scalable training systems
– Quantitatively assess solutions and propose and implement performance optimizations
– Develop end to end solutions and application flows for ease of use
– Facilitate and practice agile development focused around methodologies such continuous integration
– Guide and mentor more junior AI developers
Qualifications:
B.S. degree in Computer Science, related technical field or equivalent practical experience, hands-on parallel and distributed code development in C/C++ and parallel programming environments and libraries. Fast learner able to work independently as well as in a team environment with good written and verbal communication skills. Real world outcome-oriented problem solving skills and experience to define workable solutions in ambiguous conditions.
The successful candidate will have experience in several of the following technologies
• Deep Learning and Neural Networks
• HPC programming and code parallelization with MPI and RDMA networks
• Accelerator-based systems (e.g., GPUs, DSPs, Cell SPEs,…)
• Experience with parallel program performance analysis and optimization
• Experience using performance analysis tools such as profilers, thread analyzers
• Knowledge with current hardware architecture and industry trends in cognitive computing
• Experience contributing to research and open-source communities and/or efforts, including publications at conferences
Preferences:
– Large Scale Machine Learning experience
– Experience with accelerators, high speed networking protocols and APIs (MPI)
– Hands-on experience with at least one deep learning framework, e.g.TensorFlow, Caffe, Theano,…
– 2+ years of experience with HPC performance engineering or HPC applications areas including experience with parallel computing using MPI
– Experience in Natural Language Processing, Computer Vision, Machine Learning, Algorithmic
– Foundations of Optimization, Data Mining or Machine Intelligence (Artificial Intelligence)
– Local candidates/willingness to relocate to the San Francisco Bay Area preferred
Source: Job Diva – Job Listing

Technical Writer II: cGMP & Root Cause Analysis – Pharma (19-00381) – PA – Swiftwater

Duties:
Responsible for designing, developing, and updating required technical documentation.
Responsible for technical writing/editing for all types of documentation produced within a modern software development environment.
Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.
Document programming standards and procedures. 

Skills:
Technical writing abilities and good time management. 
Strong root cause analysis skills with cGMP experience. 
To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
Candidates with IT experience are not appropriate for this particular role.

Education: College graduate preferred. High school diploma a requirement.
Source: Job Diva – Job Listing

Scientist I (19-00380) – TX – Fort Worth

Position Purpose: Conduct advanced analytical analysis of starting materials, in-process materials, and finished materials following established procedures and protocols.
Perform material analysis by utilizing chromatographic method development and execution.
Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
Use proper scientific tools to accurately analyze and trend data, where applicable.
Clearly and accurately records data and conclusions in laboratory notebook.
Prepares technical documents, including reports and procedures.
Communicates and collaborates routinely with colleagues within the function and sometimes within the sub-team. Functionally communicates with supervisor and mentor. Participate constructively in functional teams and at lab meetings, and offers assistance to co-workers.
General upkeep of laboratory, including equipment/ instrumentation.
Revise and author procedures and technical reports as needed.

Quality – No critical audit observations.
Quality – Formal CAPAs and deviations not more than 30 days past due.
Timeliness – On time delivery of data in a suitable format (laboratory notebook, LIMS, technical report).
Throughput – Capable of managing several routine tasks at one time.
Adherence to *** standards and governing procedures and processes, in particular, quality, ethical, health, safety, and HSE standards.
Preferred Requirements: BS degree in Scientific discipline with 3 years of related experience; MS degree in related scientific discipline with <3 years; Hands-on laboratory experience with chromatographic analyses, such as GC, HPLC and UPLC, and Empower software
Source: Job Diva – Job Listing

Clinical Science Specialist (19-00379) – AZ – Tucson

POSITION SUMMARY:
In this role, you will review, analyze, and summarize scientific literature and clinical data to generate clinical evidence documentation for compliance with the European Regulation on in vitro diagnostic medical devices (IVDR). Drafts sections for package inserts and other labeling documents. Reviews and contributes to clinical performance evaluation plans and reports, package inserts, other labeling, and clinical information in technical files and health authority (HA) submissions. Stays informed of performance evaluation requirements published or communicated by major HAs.
ESSENTIAL RESPONSIBILITIES:
Actively participates in implementation of strategy to address IVDR clinical evidence requirements across the product portfolio.
Conducts scientific literature reviews, objectively evaluates data, and prepares documentation (eg, scientific validity reports and clinical performance reports) for in vitro diagnostic products.
Demonstrates understanding of intended uses of IVDs and their application in clinical practice and applies this understanding to critical review of data and preparation of reports.
Ensures high quality documentation with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines.
Works with a cross-functional team (eg, Regulatory Affairs, Development, Medical Office, Quality, Marketing) to ensure timely completion and approval of clinical evidence documentation for Technical Files.
Interfaces with Regulatory Affairs and other groups and other units to stay informed about current performance evaluation requirements published or communicated by major HAs; including but not limited to IVDR guidance documents and implementing acts.
Miscellaneous duties and special projects as assigned, including deliverable tracking, process improvement, and literature review-based reports to support product registrations and marketing applications.
Tracks progress of assigned deliverables to ensure timelines and other project team needs are met.
Serves as a functional area subject matter expert for document management.

Experience:
Minimum of 2 years’ experience in study design, data interpretation, and report writing for clinical or non-clinical studies.
Experience writing reports for regulatory submissions and marketing applications is a plus.
Experience in the IVD device industry, and/or immunohistochemistry, histology, cancer biology/oncology is desirable.
Knowledge, Skills, and Abilities:
Knowledge of:
Application of scientific principles and concepts
Literature databases and search methods
Statistical basis for diagnostic device performance characteristics
Biomarker characterization, diagnostic testing laboratory workflow, histology, immunohistochemistry, and molecular biology
Skills:
Excellent verbal, written, and presentation communication skills;
Proficiency with software programs used to prepare documents (Microsoft Word, Adobe Acrobat Professional, EndNote);
Collaborative mindset;
Outstanding organizational skills.
Able to:
Produce quality reports independently;
Drive progress on multiple projects simultaneously;
Prioritize work and meet timeline;
Follow processes and operate within a fast-pace environment;
Develop product and related disease area medical and scientific knowledge;
Develop expertise in the company’s internal document management system;
Be passionate about improving the lives of all patients afflicted with cancer.
Source: Job Diva – Job Listing

Medical Safety Lead (19-00377) – TX – Fort Worth

Position Purpose
Perform safety activities for assigned R&D projects or ophthalmic products, including identification and comprehensive assessment of safety signals from all sources (clinical through post-approval lifecycle management and externally).
Major Accountabilities
Perform single case medical review in the safety database or line listings. Medical review will be performed by clinically/medically qualified associates.
Monitor the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints, and signal detection.
Provide safety input into clinical and regulatory deliverables, including Investigator’s Brochures, study protocols, reports, and clinical submission documents, as needed.
Identify safety signals based on the review of solicited or unsolicited single cases. Performs signal triage activities, evaluation, and presentation to management boards including preparatory activities.
Author or provide safety input to the product labeling and related documents.
Contribute to the safety profiling and risk management documents.
Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports.
Provide relevant safety input and collaborates productively with colleagues from Global Medical Safety and business franchise functions.

Provide expert medical/scientific input into responses to inquiries from health authorities, healthcare professionals, or local affiliates on safety issues. Prepares safety data for health authority review boards.
Source: Job Diva – Job Listing