PTR Regional Hub Sr. Regulatory Associate (E3) /

PTR Regional Hub Regulatory Manager (E4)1

Department: Pharma Technical Regulatory (PTR)

Job Family / Category: PTR Regional Hubs

Purpose

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

Responsibilities:

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

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

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

• 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.

• Managing electronic calendar, scheduling & global meeting management including coordination of telepresence, videoconference, teleconference meetings and meeting materials
• Creating, editing presentations, spreadsheets and word documents, proofreading and compilation of special reports.
• Handling correspondence and shared electronic filing system
• Making extensive international travel arrangements.
• Preparing expense reports.
• Initiating and managing purchase orders and contract processes including PO, invoices and payment tracking.
• Arranging various recruiting activities such as on-site interviews.
• Coordinating meeting and conference arrangements, planning off-site, town hall meetings, and organizing catering
• Leading the PTD administrative team meetings to ensure alignment, awareness of new business processes, and create a sense of community. 
• Delegating various departmental administrative responsibilities and supporting the growth and development of the PTD administrative team.

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Product Manager or Sr. Product Manager 

Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics for the assigned managed care segments in the U.S. and related territories . 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 in the assigned managed care segments and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.  This role is focused on customer-specific pull-through through use of marketing tools and resources, including application of Value-based Healthcare, promotional, B2B, brand and other relevant resources for key accounts

• Acts as a key liaison to cross-segment MCCO (Managed Care & Customer Operations) account management teams and as MCCO liaison to relevant brand teams
• Consults and prioritizes with MCCO field leadership on most important accounts
• 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 for assigned segments
• 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
• Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics for assigned managed care segments
• 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
• Works with various MCCO account management teams to develop and communicate the managed care marketing strategy for assigned managed care customer segments
• Provides strategic consultation to account management-led account planning
• Identifies and recommends account-tailored marketing opportunities
• Effectively and efficiently applies VBH, promotional, B2B, brand and other relevant resources to accounts, as appropriate 
• 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 wi...

• Perform business analysis activities to design, develop, and deploy solutions including projects, enhancements and upgrades for internal customers
• Analyze data processing problems related to gRED information and planning systems including the Planisware solution and the gRED portfolio analytics platform
• Lead and facilitate meetings with Director and VP level customers to determine organizational needs and requirements and develop solutions
• Manage 2–3 major projects of diverse scope across functional areas
• Create and/or assist with required project documentation practices such as user requirements, functional specifications and service level agreements
• Resolve technical and process incidents and problems according to Service Level Agreements
• Collaborate with internal support teams and external vendors to ensure and continuously improve system stability and optimal performance for deployed solutions

MainPurpose of the Position:

• Lead the planning, preparation, and conduct of QualityAssurance staff performing a variety of routine and complex oversightactivities that meet cGMP regulations and Genentech standards.
• Lead DP MQA performance and development of direct reports toensure achievement of organizational and department goals and a productive environment.

JobDuties/Responsibilities:

• Coach and develop staff by providing an environment thatencourages ongoing personal and professional development.  Manage and ensure the setting of realisticgoals for staff and provide regularly scheduled feedback throughout theyear.  Ensure staff receives appropriateknowledge and skill development and growth opportunities.
• Manage and administer all aspects of people processesrelated to the employee life cycle.  Thisincludes the selection, hiring and training of personnel on company anddepartment policies, systems and processes. Manage and communicate compensation related information per companyguidelines.
• Accountable for systems to ensure anynon-compliant events occurring in Manufacturing are assessed in a timely manneran in compliance with Quality policies and Health Authority expectations.
• Accountable for systems to ensure documentationis reviewed in a timely manner and with a high level of accuracy.
• Guide staff in meeting goals by identifying and completingassignments.
• Recommend and implement improvements to Qualityoperational policies, plans and procedures.
• Manage routine department activities and complexQuality initiatives.
• Ensure activities and initiatives are completedon time and within budget.
• Maintaincapacity model to ensure appropriate resourcing of the area.
• Presentcomplex quality issues and potential solutions at site leadership teams (QRB,Quality Council, SMART)
• Monitor and control expenditures against the departmentbudget.
• Notify Senior Management of potential quality or regulatory issues thatmay impact product quality or regulatory compliance.
• Lead and participate in continuous improvementinitiatives for Roche Quality Systems.
• Sign documents foractivities as authorized and described by Roche policies, procedures and jobdescriptions.
• Be accountable forbehaviors described in Roche’s values and Leadership Competencies.
• Perform any other tasks as requested by SeniorManagement to support Quality oversight activities.

General:

• As required, serve as a Quality liaison with regulatoryagencies and external sources regarding issues impacting quality assurancemanufacturing.

Manufacturing Quality Assurance/EnvironmentalQuality Assurance:

• Represent MQA as the prime internal and external contact oncontracts and operations.
• Guide staff in supervising and integratingquality oversight into manufacturing operations.

The Manager / Senior Manager will support the late stage PPP team as itdelivers on a range of projects in support the late stage oncology portfolio.  Key activities forwhich PPP is responsible include:

• Portfolio Management and Reporting
• LifeCycle Team, Planning, Governance and Decision Support
• Strategic Projects at the TA Level and Cross-Portfolio
• Governance / Support for Late Stage Portfolio Committee

The role requires ability to providestrategic, analytical and systems support to late stage teams, TA heads, andother stakeholders in the Roche organization.

Responsibilities

Representative responsibilities associatedwith the role are detailed below:

• Portfolio Management and Reporting
• Participate on multiple lifecycle teams and ensure that portfolio reflects ongoing investments in programs
• Prepare quarterly reports on progress of portfolio and implications (incl. strategic context) for senior managers
• LifeCycle Team, Planning, Governance and Decision Support
• Consult with lifecycle teams to provide decision analysis and other analytic and strategic support
• Support development of business cases for all investments/changes, including valuations
• Facilitate annual prioritization, goal setting, lifecycle planning and business planning processes
• Advise teams on internal governance processes associated with changes/new investments
• Strategic Projects at the TA Level and Cross-Portfolio
• Support development of molecule, pathway and disease area strategies
• Frame portfolio issues and conduct gap analyses to enable management to make informed and timely decisions, including corporate goal setting and portfolio optimization
• Facilitate TA level opportunity prioritization and strategic context
• Support partnering opportunities at the TA level
• Governance / Support for Late Stage Portfolio Committee
• Work with development teams to ensure that decisions go through appropriate governance
• Advise teams and stakeholders to ensure decisions are aligned with portfolio priorities

Job Skills and Expectations

Clinical Specialist
NY Metro Territory

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.

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

Clinical Specialist - Lytics
Territory: Long Island, NY

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: Central Venous Catheter Management and Acute Ischemic Stroke

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.

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.  

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