Individual contributor Patent Attorney/Agent to prepare, file and prosecute patent applications, with a primary focus on the protection of inventions and patent prosecution relating to small molecule therapeutics.  Maintain a substantial and active prosecution docket of U.S. and foreign patent applications, with interference, reexamination, post-exam, and opposition practices as they may arise with prosecution. Develop in-depth expertise in particular areas of small molecule drug discovery in order to provide guidance on patent law issues to business groups and scientists conducting research in those areas. Position will also involve diligence work (including freedom-to-operate, infringement and validity analyses), agreement support work (including MTAs, CDAs, research collaborations, and licensing agreements), management of external relationships with outside counsel and collaborators, and interactions with global affiliates....

Planning Lead, Access Solutions Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Lead has an advanced knowledge base regarding Operational Quality and/or Healthcare Compliance and Privacy. This position is responsible assisting in the maintenance of all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, and the management of external business partners. Additional key responsibilities of this role are: quality and compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization as a subject matter expert on compliance related matters.

• Shares responsibility for monitoring, review and analysis of quality and general compliance for all Access Solutions operational entities. Relied upon for sound compliance guidance.
• Assists in the integration of quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations
• Assist in the management of outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• With limited oversight, develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as a team member for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on compliance matters of low to medium risk.

...

The Senior Quality Manager is responsible for proactively ensuring that all GCP governed clinical activities in PDG (Product Development Operations) are delivered to the highest standards of quality and efficiency in accordance with the appropriate Roche and industry requirements and regulations.

The Senior Quality Manager leads quality and compliance excellence within PDG by embedding quality principles throughout the organization. This is achieved through:

• Close collaboration/partnership with the PD Operational staff
• Facilitation of subject matter experts within and outside PDG
• Strategic liaison with PDQ (global quality group)
• Staying abreast of internal and external developments, trends and other dynamics relevant to the quality and efficiency of PDG

Main duties and responsibilities:

Quality Management System - Analyze and drive the QMS requirements for PDG and Implement, review and manage the QMS and monitor its performance.

Ensure cross functional alignment and compliance through process documents - Analyze/review “to be” processes, forms, templates and related process documents. Coordinate the functional subject matter experts by scheduling review and implementation of new/revised process documents  and develop and maintain effective relationships with other departments to ensure that all controlled document review activities are executed efficiently and effectively.

Risk management strategy - Implement, review and maintain strategic quality risk management activities and implement, review and maintain systems that enable identification of key risks for escalation to study teams and senior management.

Performance metrics -  Implement, review and report the most appropriate key performance indicators (KPIs) for the business and monitor their effectiveness Implement, review and maintain processes that enable oversight for PDG management and personnel on the metrics which give performance data on the chosen KPIs.

Compliance support - Drive the compliance support process for PDG in order to create a compliant workforce and workplace based on Regulator’s requirements. Provide timely GCP and process compliance support to personnel by answering questions and providing advice manage the process for escalation of compliance issues through the appropriate routes and with appropriate urgency.

Additional duties and responsibilities:

• Continuous Improvement
• Training Compliance
• Facilitating simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Lead and/or supervise other key projects as required

...

Here is an opportunity to join Roche as a Quality Manager. This position is responsible for proactively ensuring that all GCP governed clinical activities within the department (PDG – Operations) are delivered to the highest standards of quality and efficiency in accordance with the appropriate Roche and industry requirements and regulations.

The Quality Manager promotes quality and compliance excellence within PDG Operations by embedding quality principles throughout the organization. This is achieved through:

• Close collaboration/partnership with the Product Development operational staff
• Facilitation of subject matter experts within and outside PDG
• Close liaison with PDQ (global quality group)

Main Responsibilities:
Quality Management System (QMS) – You will be required to understand and maintain the QMS requirements for the business and develop and implement the QMS and monitor its performance.

Ensure cross functional alignment and compliance through process documents -  By analyzing/reviewing  “to be” processed, forms, templates and related process documents and facilitate review and approval of process documents along with global and cross functional teams. The Quality Manager will coordinate the functional subject matter experts by scheduling review and implementation of new/revised process documents.

Risk management strategy - Ensure strategic quality risk management activities are implemented and maintained and enable identification of key risks for escalation to study teams and senior management.

Performance metrics - Develop and implement the most appropriate key performance indicators (KPIs) for the business and monitor their effectiveness and gather and report on the metrics which give performance data on the chosen KPIs.

Compliance support - Provide timely GCP compliance support to personnel by answering questions and providing advice and facilitate escalation of compliance issues through the appropriate routes and with appropriate urgency.

Additional duties include:

• Continuous Improvement
• Training Compliance
• Facilitation of simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Records compliance

...

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

...

Lifecycle management of Enterprise Directory systems (Microsoft, SUN, Kerberos, Radiant Logic VD)

Lifecycle management of Federation systems (Ping Federate, Siteminder, Microsoft ADFS)

Work on projects related with these components

Create and manage Single Sign On integrations (Ping, Siteminder, JBoss)

Support other Identity and Access Management teams: Identity Systems, Access management, on/off boarding (worldwide presence)

Participate in security hardening drills, audits, proof of concept

Work on user requests, incidents and problems

 

• 2-7 years of successful technical experience supporting Enterprise Directories, Single Sign-On solutions and Federation Services for internal and hosted/SaaS applications
• Proven technical operational skills, and capability to create and validate well-structured answers and solutions in area of responsibility
• Proven interpersonal skills to interact effectively with Informatics staff in multiple countries and varying cultures
• Good understanding of Identity and Access Management systems, operations and related processes with focus on Active Directory, Federation Services, Kerberos, SUN LDAP and Password Management solutions.
• Provides 2nd level support related to Enterprise Directories, Single Sign-On and Federation Services.
• Documents the corresponding processes and components/solutions
•  

Problem Management

• Follows ITSM processes for 1st level problem management
• Act 
• s a source for establishing and recommending that multiple incidents should be declared as a problem to the relevant service providers. Tracks problems until resolved.
• Ensures accurate and complete problem tickets logged in ITSM tool adhering to Roche ITSM processes
• Ensures the Knowledge Management System (KMS) is updated with workarounds, known errors and solutions

 

Incident Management

• Follows ITSM processes for handling incidents
• Monitors ticket queues for the relevant workgroup action within agreed targets
• Ensures accurate and complete incident and change tickets are logged in ITSM tool and adhere to Roche ITSM processes
• Manages, meets and maintains service levels where appropriate
• Continuously improves own skills and knowledge base of services provided by Roche

...

HCV Clinical Specialist
Territory: Richmond, VA and Virginia Beach, VA areas


The HCV Clinical Specialist, Pegasys Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Reports to: Division Manager, Pegasys Sales

Example Duties and Responsibilities:
• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner;
helping external customers understand the benefits and use of GNE brands
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities.

...

Summary:

This is an E2/E3 Automation Engineering position mainly intended to provide support for biopharmaceutical manufacturing projects and operations as part of the Vacaville Technology Science and Engineering Automation Group. Area of focus will primarily be the manufacturing production Distribution Control Systems (DCS) system. Candidate must be a self-starter who can independently drive projects and day-to-day work tasks to completion according to a defined budget and schedule. The candidate must be able to work well with others in an informal results oriented environment.

Responsibilities:

• Software/hardware design, development, test, implementation and support for the manufacturing Distributed Control System (Siemens APACS - Wonderware Archestra DCS).

• Troubleshooting of automation issues impacting the manufacturing process, processing equipment and/or the DCS.  

• Providing 24/7  on-call support on a rotating basis.

• Providing technical assessments and evaluations for discrepancies that occur during manufacturing operations

• Providing technical input for investigation and developing and implementing automation related corrective action plans.

• Developing and revising  automation design documents

• Preparation of automation work plans and automation related change records

• cGMP compliant execution of off-line and on-line coding and testing.

• Supporting and leading Automation projects including detailed design, design review, implementation, testing/debug, and troubleshooting.

• Collaborating with the Manufacturing, BSI, Quality, Facilities, and Technology departments to implement continuous improvement changes as well as capital projects.

• Providing clear written and verbal communication across functional departments at various levels to drive efficient issue resolution and change implementation.

...

MEDICAL DIRECTOR/MEDICAL DIRECTOR - 

 

RESPONSIBILITIES:

Genentech is seeking a Medical Director with clinical and drug
development experience within our Development-Immunology organization. This individual will be responsible for strategic clinical
oversight with a focus on our scleroderma portfolio. The position will involve clinical development of novel agents. The Medical Director will be responsible for the design, implementation,
monitoring, analysis, and reporting of studies conducted within one or more programs.
They will also participate in developing the long-range strategic plans for the molecule or molecules.

...

Clinical Specialist

Territory: Central Illinois (including Springfield, Peoria, Quad Cities)

The Clinical Specialist, Franchise Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory in the Hospital/Critical Care setting. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

The applicable therapeutic area / disease states are: Acute Ischemic Stroke¿and Central Venous Catheter Management and Reports to: Division Manager, Franchise Sales¿¿

Example Duties and Responsibilities:

• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required

NOTE: This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

...

Purpose:

The Head of Small Molecules Development Products, North America, in External Quality is accountable for the development and deployment of the Quality strategy for the selection and operation of Contract Manufacturing Organizations (CMO) that support the gRED Small Molecules development portfolio. Accountable for all aspects of Quality related to these CMOs to include: Quality Systems, Product Quality Operations, Process Qualification and Validation, cGMP Compliance, Risk Management, GMP Audit and Inspection Readiness. Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold Roche’s reputation as a reliable, high quality supplier of IMP products. In collaboration with other PTx and gRED functions, ensures appropriate measures are employed to fulfill the requirements of phase appropriate cGMPs, international standards and requirements. Responsible for risk management utilizing risk management tools for each CMO within group’s scope. Accountable for the management of Quality and Compliance within the group to include: staffing, talent management, performance management, financial performance, and execution to meet strategic and operational objectives.

Responsibilities: 

* Management of the North America Small Molecule Development Products Group

* Staff and assign Quality Managers to lead quality teams for IMP products after approval to proceed to development utilizing CMO manufacture 

* Lead Quality Managers in the implementation and execution of Quality processes for the selection, implementation, and ongoing management of development CMOs

* Accountable for the Quality and Compliance Status for all CMOs within the group’s scope of operations 

* Establish and manage performance metrics for the Key Performance Indicators (KPI) 

* Determine staffing requirements and provide input to department budget

* Establish individual goals for direct reports, provide performance management for direct reports, and conduct talent management in accordance with Roche standards and procedures

* Accountable for the deployment of the Roche PT Pharmaceutical Quality System (PQS) standards and requirements for outsourcing for all Small Molecule Development CMOs used for the gRED portfolio, ensuring appropriate risk assessment and mitigation for identified gaps

* Participate in Joint Steering Committees through the established Governance processes as required. Define quality actions to be resolved and/or escalated to Roche senior management at the Executive Steering Committees.

* Accountable for approval of:

* Quality Agreements Appendices, such as PSRs, for Development CMOs on behalf of Roche Quality

* IND and IMPD Manager Level reviews

* Major Deviations or Changes in Roche Approval systems

...

The Principal HR Business Partner is the "local" HR business partner for the Finance and Procurement organizations based in South San Francisco and is part of the Corporate Groups HR and Employee Relations team.  This role is the strategic business partner to leaders and leadership teams within the client organizations, including one Genentech Executive Committee member.  This position will have to manage complex/matrix relationships on both a local and global level, collaborating effectively across business and HR networks/partners. 

The person in this role will consult, advise, coach and partner with the business on people and organizational needs -- ensuring alignment with agreed Group, functional and regional/site initiatives as well as business strategy.  This role also partners with leaders to drive organizational effectiveness including change management.

RESPONSIBILITIES:

• Act as key HR point of contact, trusted advisor, and sounding board for client LTs.
• Identify, define and implement solutions that address the needs of the business whilst taking into account the broader implications (e.g. Group HR strategy, other functions).
• Contribute to the business strategy. Drive the People Agenda by applying broad HR skills in the areas of organization design and development, change management, workforce planning, coaching/consultation, program/project management, facilitation and communication. Plan and implement people/organization solutions aligned to the business & Group HR strategy and goals (i.e., actively sponsoring and leading goals at LT level).
• Ensure excellent alignment and execution of established human resources policies, procedures and Group, functional, and site HR initiatives.
• Successfully execute global and local HR processes (for example, talent management, succession planning, performance management, development planning, compensation planning).
• Partner with Global/Regional HRBPs to align and execute on initiatives and Group processes (this includes providing input to and leveraging tools and templates from CoEs where appropriate).
• Identify talent issues before they affect the business. Act as a talent scout for internal talent for local and global key positions and help develop the next generation of leaders through talent management and career development. Contribute to assessment/selection for senior leaders and other critical positions.
• Determine most efficient and effective way to deliver services based on costs, ratios and appropriate Key Performance Indicators. Collaborate with service organizations.
• Ensure compliance of all HR practices within area of responsibility and with legislative and regulatory requirements, standards and other known relevant policies and guidelines.

...

Purpose:

The Quality Engineering manager works independently and provides oversight of quality engineering activities during design development. Be the quality engineering subject matter expert during device development, manufacturing, technology and associated verification and validation. 

Job Responsibilities:

* Works closely with Device Development and device CMOs to assure that combination products maintain their requirements and specifications and are compliant with the Quality System

* Liaises with technical groups to review and revise specifications based on design and/or process changes

* Supports root cause analysis in the implementation of corrective actions

* Responsible for continual improvement activities and liaises with experts to apply appropriate improvement tools

* Provides technical consultation on the development of fixtures, methods, test equipment, and tooling in order to continually improve process and products 

* Establishes quality inspection processes and supports quality activities to ensure that products and processes comply with the relevant requirements of the quality management system.

* Supports internal/external audits and vendor qualification, including closing out audit findings and determining proper corrective and preventive actions.

* Responsible for planning, organizing, and managing the overall testing activities of quality functions.

* Collaborate on and /or author policies and procedures and act as a trainer / subject matter expert on applicable quality systems, standards or business processes (as required). 

* Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance and technology.  Perform any other tasks as requested by Management to support Quality oversight activities

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

...

Sr./Training Manager - Medical Affairs / Thought Leader Services

The position of the Sr./Training Manager - Medical Affairs / Thought Leader Services will be accountable for planning, developing, facilitating, and evaluating training education programs for the Medical Partners Team which serves both U.S. Medical Affairs (gMed) and the Thought Leader Services-Commercial Compliance Operations (TLS-CCO) group. The focus of the work is to design, develop, and deliver high-quality and high-impact learning products, programs, and services that provide the functional knowledge needed by our partner clients to achieve a high level of performance in their jobs.

Major Responsibilities
* Design, develop, analyze, and evaluate training strategy and solutions, including interactive instructor-led courses, self-instruction, online learning, job aids, and other performance-based solutions
* Facilitate and deliver training courses, as needed
* Market programs to ensure awareness and proper utilization, develop and execute internal communications plans
* Edit training materials for formatting, flow, readability, and educational effectiveness
* Create metrics and assess impact of training programs
* Provide Onboarding to new employees, orienting them to the gMed and TLS-CCO organizations, functions, and roles as appropriate
* Develop a deep understanding of critical cross-functional training needs
* Collaborate with Commercial Training & Development (CT&D), gMed, and TLS-CCO decision makers to identify and engage appropriate stakeholders to achieve project objectives
*Able to build strong partnerships internal to the team, to CT&D colleagues, and external to the partner client groups
* Partner with departments, subject matter experts, and key stakeholders to identify training needs and develop/improve functional area training solutions, focusing on performance-based activities and tools
* Track and report project progress via a variety of communication vehicles including PowerPoint presentations, and print and electronic media
* Lead or participate in projects designed to improve training and learning throughout Commercial, applying standards, performing needs assessments and evaluations, as appropriate
* Identify external vendors and internal resources for training programs and consolidate purchasing of training resources, where applicable, to ensure maximum discounts
* Participate in project teams and committees, as appropriate
* Continuously improve learning and development experiences by integrating new concepts, methods, approaches, technologies, and content

...

Main Purpose of the Position:

• Supervise and develop Environmental Quality Control and Microbiology (EQCM) staff that perform routine and moderately complex testing activities and follow cGMP regulations and Genentech standards.  

• Supervise performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:

• Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.

• Coach and develop staff by providing an environment that encourages ongoing personal and professional development.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.

• Assign activities to staff.

• Routinely monitor progress and completion of assigned staff activities.

• Supervise routine activities of moderate complexity.

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

• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

• Meets scheduled performance of 95% on time.

• Perform any other tasks as requested by Senior Management to support Quality activities.

Technical Duties/Responsibilities:

• Provide technical and compliance guidance on test methods.  

• Review, evaluate and approve test data against established criteria.

• Provide input for the resolution of Out of Specification (OOS), complaints, discrepancies and Corrective and Preventive Actions (CAPA).  Design testing strategy to support investigation.

• Review technical / investigation reports and provide input as requested.

• Identify potential improvements to Quality Control systems and procedures gaps, and implement improvements as directed.

• Provide guidance and coaching in the application of cGMP throughout Quality Control operations.

• Receive and provide training.

• Participate in collaborations to support complex and/or multi-site projects.

• Participate in internal and external audits and regulatory inspections.

• Provide input and guidance to authors of protocols and reports.

• Review and approve proposed changes to systems, test procedures, test methods, procedures and submissions to regulatory agencies.

• Participate in validation and qualification studies.

...

Position Purpose:

Epidemiologists work under the supervision of a Global Epi TA Head to review, generate and interpret quantitative evidence on disease from observational data sources to strengthen decision-making and minimize risk throughout research and development.

Major Responsibilities and Accountabilities:

• Works independently using effective epidemiologic principles and methods
• Works effectively in project teams
• Responsible for epidemiologic deliverables to project teams

Primary Skills/Features:

• Contributes to the design of safety signal investigations
• Researches and provides background adverse event rates in order to contextualize observed adverse events
• Designs observational studies and writes protocols under supervision
• Serves as an epidemiologist on observational study teams
• Provides guidance for ensuring data quality during study conduct
• Experienced with principles and techniques of data analysis and interpretation
• Contributes to study reports, analysis plans, and publications for observational studies
• Represents epidemiology and works independently and effectively on cross-functional teams
• Management (projects and/or personnel)
• Manages epidemiology projects for teams
• Identifies and manages contracts for vendors and outsourced projects
• May mentor associate epidemiologists, contract epidemiologists, & interns

Communication:

• Develops agendas, leads meetings, and provides periodic updates to project teams and senior managers
• Seeks appropriate communication channels
• Effectively articulates how epidemiology supports project goals
• May interact with the FDA and other agencies
• Selects appropriate consultants for contract work
• Is highly professional & scientifically rigorous
• Builds an understanding of roles and responsibilities of other functional areas
• Educates teams on epidemiologic methods and principles

...

• Provide project management and administrative support for project team working to determine feasibility of Leadership Energy and Environmental Design (LEED) Certification.

• Work with LEED consultant to set clear performance expectations for team members to ensure successful completion of project objectives.

• Communicates and coordinates among all stakeholders within and outside the GNE organization including but not limited to client groups, service providers, suppliers, procurement to collect LEED Certification data.

• Manage data collected to enable reporting required to generate reports for feasibility or certification processes.

• Organize and develop material for presentation to Genentech and members of the U. S. Green Building Council (USGBC) for LEED Certification.

• Demonstrated success in leadership and organizational management in a technical, team orientated environment.

• Demonstrated ability to anticipate, prioritize, and adapt to changing workload situations.

• Excellent interpersonal and communication skills.

...

As the Medical Director you willbe responsible for the design, implementation, monitoring, analysis, andreporting of studies conducted within the Late Development Oncologyorganization. You will also participate in developing the long-range strategicplans for the molecule or molecules within the area of Oncology.

 

Key Accountabilities:

Assisting in the overall management,planning, evaluation and documentation of projects and studies

Participation in on-going medicinedevelopment activities including:

•  Preparation of regulatory documentsand interaction with global regulatory authorities

•  Monitoring and reviewing incomingdata

•  Analysis, presentation andinterpenetration of on-going studies and published data

•  Interactions with health authoritiesand expert bodies

•  Close collaboration with drugsafety, regulatory affairs, medical affairs and clinical trial operations

•  Participation in the preparation ofabstracts, posters and presentations for scientific meetings and congresses

•  Developing and writing clinical plansand protocols ensuring that they are scientifically sound

 

To be successful in this role, youwill have the following skills and experience:

•  Solid experience in medical research includingwriting clinical study reports and interpreting clinical data

•  Good communication and collaborativeskills with experience at working with cross-functional and external groups,including researchers, clinicians and other stakeholders.

•  Proven track record of delivery ofexperimental or novel studies

Confidence at presenting at internaland external strategy meetings

...

Position may be filled at either the N4 or N5 level depending on qualifications of the selected applicant.  The position will be in either the Raw Materials, Network Product Testing, Site Product Testing, Environmental Monitoring/Microbiology, or Lab Support Quality Control group and may require off-shift and weekend work schedule.

Main Purpose of the Position:

Perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC laboratory operations.

Job Duties/Responsibilities:

• Perform testing of routine and non-routine samples and document according to GMP.

• Review data and assess against established acceptance criteria

• Perform technical review of peer-generated data for basic methods

• Prepare data tables and graphs

• Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.

• Receive and provide training

• Participate in assay transfer and assay validation.

• Perform equipment qualification / maintenance

• Prepare and maintain standards, controls, stocks, and cultures per established procedures

• Support the maintenance and compliance of operational areas.

• Assure and apply GMP throughout operations.

• Coordinate with customers to support operational activities.

• Support internal and external audits.

• Work to meet schedules.

• Identify and support resolution of technical problems.

• Actively participate in group and project teamwork; project and process improvements.

• Drafts protocols and reports under supervision.

• Meets scheduled performance of 95% on time.

• Perform other duties as requested by managers to support Quality activities.

...