The Department of Bioinformatics and Computational Biology in
Genentech Research is seeking a motivated individual to lead the
development of software methods and infrastructure for the analysis of
high-throughput biological data. This work will be in close
collaboration with other computational researchers, as well as the
broader community of Genentech scientists, who are together seeking
novel therapies for unmet medical needs. Much of the software will be
developed in R, as it is our primary data analysis
environment. Interesting challenges include the scale of the data and
the need for agility in a fast-paced, dynamic research
environment. Publishing of methods and software is encouraged, and
there is potential for collaboration with open-source projects. There
is also opportunity for investigating open scientific problems in
computational biology, such as variant calling, functional assessment
of non-coding transcripts, and the relationship between copy number
variation and expression....

This IT Manager is responsible for managing the Portfolio processes for Research and Development IT and for providing Project Management on a variety of projects that are used by Research and Early Development.  The position also oversees Portfolio/Project Management, Budgeting, Forecasting and related processes for Research and Development IT.  The position is part of the gRED IT organization.

Responsibilities: 

• Acts as Project Manager on projects, as assigned.
• Ensures that formal project management processes (PMM) are adhered to 
• for planning, chartering, and management of strategic initiatives and 
• projects. 
• Establishes and manages project teams and core teams to develop and 
• execute project plans. 
• Monitors projects and their progress towards goals, provides status, and 
• ensures issue resolution. Manages project budget and timeline to ensure 
• that they are efficiently delivered.
• Identify and implement process improvements in solution delivery and 
• support of new and existing solutions
• Collaborates with Pharma Informatics technology groups and business 
• functional groups, to ensure project delivery and on-going support of 
• applications.
• As the Portfolio Manager for gRED IT, partners and coordinates with Finance, gRED IT project managers and functional managers, other Portfolio Managers and the business to ensure appropriate project methodologies, governance and control processes are followed.  Also coordinates annual budgeting and monthly forecast/actuals processes and acts as the gRED IT representative on larger Pharma IT portfolio process improvement efforts.  Provides support and guidance to gRED IT project managers, as needed.
• Coordinates the yearly and project budget processes, including monthly forecasting, actuals analysis and resource management processes for your area of responsibility. 
• Provides support to the Director of gRED IT, as needed, related to creating general presentations, leading certain recurring meetings, etc.
• Participates in the Leadership Team of gRED IT organization

...

Job Summary:

Working in early clinical development at Genentech /Roche Inc gives the opportunity to provide translational safety contribution to projects combining good understanding and knowledge of toxicology and expertise in clinical safety and early clinical development, a very innovative approach where Genentech/Roche is a pioneer. 

Job Purpose: The Safety Science Leader (SSL) is accountable for all aspects of safety related to products in early development phase including single case assessment, aggregate reporting, integrated signal prediction/detection (ISP/ISD), integrated risk management process (ISMP) & comparative benefit/risk (in collaboration with Clinical and Regulatory) throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate to ensure that adequate safety measures are implemented based on data. ¿The Safety Science Leader maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product or medicine and is accountable for safety components of various documents including study protocol, study reports, development study reports. The Safety Science Leader represents Safety Science in Research and Early Development teams (RED teams) . She/ He supports and facilitates transition of projects from early to confirmatory development for all aspects pertinent to safety. 

 

Primary Responsibilities and Accountabilities:

·      Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 

·      Reviews all communications to the public from a safety point of view. 

·      Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 

·      With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.

·      Is accountable for safety components of all NDA documents. 

·      Is responsible for the writing and maintenance of RMP/REMS NDA documents. 

·      Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  

·      Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 

·      Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates.

 People Leadership: 

·      Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 

·      Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  

·      Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.

·      Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 

·      Actively installs the Roche values in the Safety Team and their activities.

...

Position Overview/Job Responsibilities

Genentech Government Affairs’ Public Policy and Reimbursement team is seeking a qualified policy manager/senior policy manager candidate to monitor and analyze numerous public payer activities and trends, including coverage, coding, and payment policies at the national level for both Medicare and Medicaid.

Specifically, the policy manager/senior policy manager will help recognize, assess, and communicate key policy issues that may impact Genentech and the biotechnology industry in both the short- and long-term to key internal and external stakeholders. He or she will focus on the impact of public sector trends and initiatives on Genentech with respect to patient access, reimbursement, and customer satisfaction. He or she will translate policy developments into meaningful guidance and strategic advice and will represent the Public Policy team at internal and external meetings. He or she also will be responsible for managing projects effectively and efficiently, and will be required to take initiative to identify key issues and help organize and assist the efforts of other team members as appropriate.

...

Sr. Product Manager

 Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.

•  Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share

• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives

• Reviews and assesses cross-functional business strategies, plans and tactics; using to determine and recommend managed care marketing strategies, plans and activities that support optimal formulary  positioning, reimbursement, access and overall market share

• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results

• Develops the Value-based Healthcare (VBH) strategy and tactics; including driving and shaping key customer partner initiatives in oncology

• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 

• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans

• Conducts field visits with key customers to review Genentech’s breadth of offerings

• Develops key VBH resources for MCCO (Managed Care & Customer Operations) field, collecting customer insights, creating tactics for case managers and training MCCO on resources

• Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence

• Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.

• Provides strategic consultation to brands and MCCO groups regarding key brand market events

• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners

• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility

• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments

• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives

• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
  Complies with all laws, regulations and policies that govern the conduct of GNE activities
  

...

Position Purpose:

To provide high quality management, coaching and functional expertise to individuals so that they maximally contribute, deliver and develop.

 

To contribute to Study Management function to develop as a Centre of Excellence for either insourced or outsourced studies and ensure effective implementation at the Site.

Major Responsibilities and Accountabilities:

 

1.     People Development and Management

 

·       Manage, coach and develop people in order to maximize their capability and contribution to provide high quality deliverables.

·       Create a positive work environment by encouraging mutual respect, innovation and accountability at all levels (local, global, functional, projects/programs).

·       Ensure that employees are appropriately trained, developed and coached to comply with Company and regulatory standards.

·       Ensure that communication is managed consistently in a timely manner with the appropriate context.

·       Support management and staff in a matrix environment.

·       Conduct ongoing performance management dialogue. Complete the required steps of the performance management cycle.

·       Conduct individual development plans/career discussions.

·       Actively contribute to the performance calibration, talent management and succession planning process.

 

2. Functional Expertise and Oversight

·       Maintain an oversight of execution of work and deliverables.

·        Ensure that standards and processes are implemented locally to create consistency, efficiency and high standards of compliance.

·        Work effectively with the relevant local and global management to ensure that sufficient, appropriately qualified resources are identified, made available and allocated.

·        Lead/contribute to regular functional forums (at all levels) to ensure knowledge sharing and consistency.

·        Advocate/drive changes within the organization and lead by example.

·        Ensure adherence to company and departmental policies, procedures, guidelines and training compliance (including time reporting, travel approvals, expense reports, conference attendance, etc.)

·       Escalate issues when needed and encourage resolution at the lowest appropriate level.

·       Contribute to the development of global standards, processes and functional initiatives.

·       Proactively manage key stakeholders.

...

This position may be filled at a Contract Manager  or Sr. Contract Manager level.
 
The Managed Care Contracts Group manages the contracting process from development of an account-centric contract strategy through execution of an agreement. The Contract Manager, Managed Care Contracts develops, drafts, analyzes, negotiates and gains the necessary approvals for the assigned managed care accounts and contracts.

• Works closely with partners in field Account Management across MCCO Channel and Payer Field teams as well as GNE Government Affairs, reviewing customer contract needs, requirements, etc. in alignment with GNE contracting strategies, business objectives, and other contract conditions
• Conducts various analyses and modeling of appropriate contract terms and reviews with key internal partners/stakeholders
• Obtains all appropriate and required internal reviews and approvals for contract terms and provisions
• As needed, supports field Account Management partners in negotiating contract terms and conditions
• Responds to various partner/stakeholder questions, inquiries, requests for clarification, etc. regarding contracts and terms/conditions or other items
• Ensures execution of approved and finalized customer contracts; including timely and accurate hand-off to other internal partners/stakeholders
• Monitors existing customer contracts using approved performance methodologies, tools, etc.; includes identifying and recommending opportunities for improvement
• Helps garner maximum return on investment and customer satisfaction from all contract responsibilities
• Ensures all contract data and information is appropriately entered into relevant systems/databases
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities
•  Business travel, by air or car, is required for regular internal and external business meetings
  

...

E4/E5

The purpose of the role is to provide high quality evaluation and sourcing of oncology, hematology, and tumor immunology opportunities.  This individual will also lead confidential due diligence evaluations and pursue BD licensing and partnership opportunities.

Job Duties/Responsibilities:

Responsible for screening potential oncology collaboration opportunities.

Lead more detailed diligence on selected high priority deals as part of diligence teams.

Provide effective liaison with Early Clinical Development.

Serve as a member of the Oncology Portfolio Committee.

Proactively source appropriate opportunities for GNE consideration from academic, literature, trade publications, meetings, etc.

Education of other BD professionals, including reviews of technical literature.

As appropriate, pursue BD licensing and partnership opportunities.

...

Job Purpose:

The Team Lead for CSV auditors in PDQA is responsible for recruitment, management and leadership of department audit staff.  Through their leadership and direction, they ensure consistent implementation of PDQA processes and procedures and execution of the audit strategy related to Computer System Validation

Primary Responsibilities and Accountabilities:

• Provide leadership and direction to the PDQA CSV audit team in the execution of the department strategy
• Recruit, manage, train and develop staff
• Motivates and manages team members through setting of individual goals, provides on-going feedback and performance evaluations
• Oversee staff expenditures
• Collaborate with other Team Leaders to resource and manage the audit program in line with PDQA Strategy 
• Manage resources according to department strategy
• Review staff deliverables (audit plans, audit reports, quality plans, etc)
• May participate on audits as necessary (staff evaluations)

• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools

• Supports Head of CSV Strategy and TL, Validation Analysts to establish and implement global CSV strategy, goals and objectives for team
• Participates on IT/CSV projects and task forces to provide quality management oversight

• Ensure consistent execution of PDQA strategy, processes and procedures
• Oversee execution of department strategy, processes and procedures
• Provide CSV compliance advice to staff 
• Ensure audits are conducted and reported in compliance with departments procedures
• Support regulatory authority inspections
• Escalate compliance issues/risks to PDQA Management
• Maintain knowledge of HR Corporate policies and procedures
• Maintain knowledge of current regulatory, GCP, GLP, CSV and/or PV regulations and guidelines and company policies, SOPs and procedure

...

A multi-talented Informatics specialist in San Francisco is needed for the Global Pharma Informatics Safety Risk Management team. In this role you will work closely with the Business System Owner, users, development and support teams, vendors and service providers to provide an excellent service for the Drug Safety Systems globally. 

A true multi-talented professional is required – willing to play multiple roles as required within a dynamic global team – to ensure optimal support, service and application delivery to our internal customers.  You will act in multiple capacities such as service manager, solution life cycle manager and business analyst. Activities you are likely to be doing in this role are (but not limited to):

• Ensure Support globally is seamless and following our Global Support Model  - your primary responsibility will be the users in the Americas (North, Latin and South America), however you and your team may need to deal with critical incidents not resolved by the team located in the EU.
• Work in close collaboration with other Delivery Service Managers to ensure global support and prioritization of incidents and assignments
• Work closely with business users, business system owner and informatics to keep all stakeholders abreast of any significant impact and changes to the systems.
• Ensure the validated state of our systems and ensure compliance with applicable SOPs and policies governing the systems and processes.
• Provide business process support by understanding existing business processes, and offering advice, implementation of changes or reconfiguration to meet business objectives.
• Provide technical support and trouble shooting for our Safety Risk Management applications.
• Work in collaboration with business to identify business solutions and requirements for new functionalities, and performing impact analysis on systems and processes, and potential ongoing projects
• Work with vendor/service providers to ensure compliance with SLAs and support in service improvement initiatives.
• Develop excellent relationships with all layers of business
• Participation in systems projects
• Openness to take on new tasks and challenges outside the formal role description corresponding to skills and capacity

...

We are seeking an energetic and accomplished Research Associate/Senior Research Associate in Early Discovery Biochemistry within Genentech.  Our group conducts early drug discovery and new target validation from a biochemical/physical, structural, and computational perspective and collaborates with diverse discovery biology areas in Genentech. The candidate must have excellent skills with directed evolution techniques, such as phage display, yeast display, and/or mRNA display. Preference will be given to candidates who also have experience in computational biology and/or biophysics. Projects will span a wide range of areas, and the candidate must be flexible, creative, and able to master new techniques as needed.
...

Dept: Biological Assays, Method Management and Technology, PTQBP

Job Category: Quality
Location: SSF

Department: MMTech (Method Management and Technology)
Description: Senior Scientist Bioassay

Summary

The Biological Assay Function within Genentech’s Global Quality Organization is responsible for life-cycle management and innovation of post-BLA biological potency methods and specifications. We serve as the scientific and technical Center of Excellence for biological assays and analytical ELISAs within Commercial Quality for the Roche/Genentech Global Quality Network. We are looking for an experienced Senior Scientist to take on a leadership role and to play an integral part in the function.

 
Requirements

Candidates must have in-depth experience in the development of cell-based potency assays and immunoassays in an industrial setting. Understanding of mechanism-of-action of antibody-based protein therapeutics is essential. Broad experience with a variety of biological in-vitro systems is required. Familiarity with antibody effector function determination and enzymatic assays would be an asset. Prior experience in assay validation/ qualification and technology transfer are highly desirable, as is GMP experience and a strong sense for compliance. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Working knowledge of statistical approaches will be helpful. Must be highly motivated and comfortable working independently in a fast-paced environment. Experience with regulatory submissions (IND/BLA) and Health Authority interactions will be advantageous. Management experience of direct reports is expected.

...

This position is responsible for providing leadership and direction to a purification process development group in Purification Development.  The candidate will lead a team of 12-18 staff comprised of several groups of scientists and engineers and be responsible for the management and leadership of multiple early stage and late stage development and technology projects.  A high degree of initiative is expected to assess new areas and directions critical for Pharma Technical Development and Genentech’s future success.  Strong management skills to lead, motivate, and develop staff in their group is a key requirement for this position.  The candidate is expected to provide leadership to their groups and throughout Purification Development and across Pharma Technical Development.

...

·         Follow company policies and procedures and be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies

·         Lead product complaint investigations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.

·         Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

·         Develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 

·         Ensure appropriate application & integration of cGMPs in the product complaints management system.

·         Set personal performance goals and provide input to departmental objectives.

·         Establish work priorities to meet targets and timelines and manage competing priorities/

·         Serve as the Quality representative on cross-functional and multi-site teams.

·         Identify, design, and implement process and system improvements.

·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·         Develop, train, and mentor personnel and internal customers on relevant business processes.

·         Collaborate and author department policies and procedures.

·         Make decisions that impact the goals and objectives of the department.

·         Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Inform management of critical product complaints and provide timely impact assessments of potentially affected products, materials or processes.

·         Review and approve product complaint investigation reports and supporting documentation. 

·         Lead collaboration with departments to establish appropriate, efficient, and timely investigation strategies.

·         Educate departments on the best practices for conducting investigations and root cause analysis.

·         Lead project teams to resolve deficiencies identified through the root cause analysis process.

·         Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.

·         Present product complaint records and/or reports during periodic audits and regulatory inspections.

·         Perform any other tasks as requested by Management to support Quality oversight activities

...

This position is part of the drug product group within Biologics Manufacturing Science and Technology (BMSAT) organization. The successful candidate will work with a team of engineers and manufacturing technical specialist responsible for fill-finish technology transfer to contract/partner manufacturing sites, as well as process transfer between Genentech/Roche manufacturing sites. The successful candidate will also be responsible for providing ongoing technical support for drug product manufacturing processes across the Genentech/Roche network.  Candidate will ensure technical stewardship across the various CMO product transfers as well as ongoing continuous improvement projects. 

• Serve as a technical lead for one or more fill-finish process transfers to contract/partner manufacturing sites, as well as between Genentech/Roche manufacturing sites.
• Provide on-going fill-finish manufacturing support to the CMO or internal manufacturing sites by performing trouble shooting, product impact assessments during deviations and investigations and process improvements. 
• Work collaboratively with the site MSAT groups, Late Stage Pharmaceutical Development groups, Manufacturing Operations, and Engineering to develop in-depth knowledge of the fill-finish processes and to facilitate technology transfers.
• Author and review technical reports, process validation documents, and portions of regulatory submissions to support licensure.
• Identify and communicate manufacturing best practices, and work to ensure manufacturing process consistency across the different fill-finish facilities.
• Lead and participate in cross-site and cross-functional teams responsible for technical oversight of drug product manufacture and process improvements, developing global standards, troubleshooting issues, analysis of cross-site process performance data and implementation of quality standards.
• Lead and/or guide the product technical teams (PTTs), serve as a member of the PTT, collaborate closely with the product supply chain, quality and regulatory lead.  Participate in Joint Management Teams (JMT) for CMO transfers for functional representation and/or team updates.

...

System Specialist, gRED Desk-side Support

• The gRED Desk-Side Support Specialist supports multiple computing platforms such as Mac, Windows, Linux, and iOS in laboratory and desktop computing environments. 

• The successful candidate will also apply networking concepts, printer troubleshooting, hardware and software troubleshooting knowledge and data backup technology in day-to-day operations. 

• While working in a highly team-oriented environment, the gRED DSS Specialist will work to achieve defined metrics within the incident management and request fulfillment processes and also be a technical resource to junior team members. 

• The successful candidate would also have the potential to lead team efforts. 

...

CDM Process Analyst

Performs tasks described in previous job level and additional tasks as specified below:

1. Represents CDM PTM within the Biometrics community

2. Provides guidance on CDM best practices and compliance based upon existing controlled documentation

3. Facilitates the development and refinement of CDM processes

4. Adjudicates comments to ensure the process reflects current business practices

5. In collaboration with subfunctional managers, develops, reviews and updates job role training qualifications

6. Liaises with PDQP regarding the creation and ongoing maintenance and training of processes

7. Serves as the single point of contact at the respective sites to the Inspection Readiness Coordinator

8. Recommends process improvements based on other companies and industries through literature review, attending professional conferences and direct sharing of information

9. Ensures document consistency

10. Acts as change and transition agent during new process implementation

11. Develops and maintains standard tools and templates to support Clinical Data Management processes

12. Ensures job role training qualifications are in alignment with industry

13. Challenges and supports Clinical Data Management staff to critically review

current processes for effectiveness, quality and simplification

14. Provides mentorship to less experienced Process Analysts

15. Provides guidance and oversight to PTM contractors

16. Contributes or leads local and subfunctional working groups and initiatives

17. Leads or participates in the local functional/crossfunctional implementation of best practices and process improvement initiatives

18. Is responsible for complex deliverables for the subfunction for one or more projects

19. Effectively communicates ideas, project goals and

status of work and independently presents at department meetings

20. Identifies and develops solutions to complex problems

21. Sets targeted timeframes for deliverables and anticipates potential scenarios that may create timeline delays

22. Is able to influence and negotiate a positive outcome

23. Evaluates probability, impact and priorities of risks and develops and implements mitigation plan

24. Articulates functional knowledge in the development of subfunctional processes, training and related documents

25. Partners with PTM Training community to ensure best training practices are being leveraged in process training

...

 

 

Responsibilities: This position is for a Validation Engineer I/Manufacturing Technical Specialist I - Validation reporting to a Manager of Technology Validation in the South San Francisco Production Technology Department.  The candidate will be responsible for Validation scope supporting the South San Francisco manufacturing plants.  This includes drafting and execution of validation protocols, authoring validation and technical reports and development of project plans.  In addition, the candidate will support technical assessments for quality impact and participate on quality investigation teams.  The candidate will also monitor maintenance of the validated state of basic and some complex equipment and processes.  This includes monitoring operations and resolving moderate validation issues.  The candidate will support introduction of clinical products into manufacturing by participating on campaign/product planning teams and delivering the appropriate validation activities consistent with project timelines.  The candidate may lead cross functional teams or projects.  The candidate will be expected to work effectively in teams, to influence others to generate support for assigned activities or projects and to justify goals to department colleagues.  They will also act as a mentor for those with similar or less validation expertise.

...

IT Quality is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual responsible hosting and supporting audits and inspections and ensuring audit corrective actions are tracked and closed in a timely manner.   The position is responsible for effective planning and management of audits and inspections with business quality and audit groups.  Further responsibilities include:

• Leads, hosts,  and supports audit management for IT for various sites for internal and external audits and inspections and provides regular updates to stakeholders and informs management of potential issues
• Prepares IT teams for audits and inspections using his/her knowledge of IT controls and auditing practices and provides training to IT staff in support of key IT controls and audit readiness procedures
• Manages the audit program in compliance with quality requirements for ICFR, FDA regulations, legal and security policies, IT controls.
• Facilitates execution of corrective actions ensuring that weaknesses identified in the IT management system are identified, recorded, prioritized and addressed appropriately.  
•   Conducts vendoraudits and internal system assessments for Informatics
• Serves as custodian for legacy IT controls, IT Narratives, Master Audit Schedule to support audit and compliance processes.
• Develops, monitors and improves processes and tools to improve the compliance of  IT systems and to facilitate joint business decision making from a cross-functional and global perspective
• Develops strong working relationships with and partners effectively with IT delivery teams and with global Business Quality, Corporate Audit, Finance and security organizations
• Maintains industry knowledge and skills in the compliance, audit, and risk management and  applies them to improve internal processes and practices

...

TheImmunology, Tissue Growth and Repair Diagnostic Discovery Department is seekinga motivated, interactive and flexible Senior Research Associate to perform researchrelated to biomarker discovery and analysis in infectious diseases. 

Theposition will report to a Scientist lead for the Department's new program inInfectious Disease and Host-Pathogen responses. The successful candidate willimplement a variety of in vitro and in vivo molecular, proteomic and cellulartechniques to elucidate disease pathways and identify relevant biomarkers, andwill be expected to make intellectual as well as technical contributions to theteam. Responsibilities: Perform wet lab experiments, generate and analyze dataand communicate findings and interpretations relevant to the Department'smission to identify predictive and prognostic biomarkers for therapeuticResearch and Development programs. Specific responsibilities will include:performing exploratory disease-oriented research utilizing samples & datafrom human infectious disease cohorts, processing and analyzing clinical trialsamples, data analysis and presentation, and contributing to experimentaldesign/planning.

...