(External Quality, Commercial Drug Substance)

Sr. Technical Manager, Tech Transfer – Biologic Drug Substances (SSF)

Main Purpose of the Position: 

* Provide Quality oversight for Roche and Genentech products manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and Roche/Genentech standards. 

* Serve as the Quality single point of contact for designated CMO(s) and participate as a key member of Drug Substance (DS) CMO governance teams to support site selection, product technical transfers and on-going external commercial site management.

 

Responsibilities:

* Participate in site selection and product technical transfer activities at CMOs, such as due diligence audits and GMP readiness activities.

* Manage all required activities to support release of commercial product including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls. 

* Develop, negotiate and maintain CMO cGMP quality agreements and ensure compliance with agreements.

* Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.

* Participate in regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs.  Support regulatory filings for products manufactured at CMOs.

* Support creation of Annual Product Reviews, product complaint investigations, and other quality functions as required.

* Establish CMO goals/metrics and monitor and report progress. Lead or participate in CMO or cross-functional process & quality improvements projects.

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Genentech has an opportunity for a Senior Scientific Manager to oversee the operation of the Translational Immunology group.

Responsiblities Include:

• Development of new in vivo models of autoimmune, inflammatory, and infectious diseases that reproduce significant aspects of human pathophysiology, as reflected, in part, by response to human standard of care therapeutics or their surrogates.
• Generation of new assays in preclinical species to ascertain and understand PKPD relationships of specific new molecular entities (NME), as well for the performance of efficacy experiments with NMEs in appropriate models.
• Interaction with discovery laboratories in which the NMEs are generated in order to design and execute appropriate experiments to characterize the NMEs and their effects, as well as to develop technologies required for the pursuit of the scientific objectives of the discovery laboratories and of Translational Immunology.
• Translational Immunology representation on NME teams. These roles will be performed both in his/her own laboratory and by oversight of three additional laboratories.

...

The Senior QC Associate within the Biological Technologies group in Analytical Development and Quality Control will be responsible for all aspects of automation for all phases of clinical trials utilizing precision robotics.  The Sr QC Associate will support the execution of vendor IQ, OQ/PQ documents, write and execute instrument, assay validation protocols and IQ, OQ/PQ documents.  The associate will also support the development of R&D assays onto high throughput automation platforms utilizing liquid handlers, plate readers and high content analysis instruments.  The candidate will identify and evaluate new technologies and work collaboratively with different research and development departments.  Expectations will also include writing test procedures, SOPs, protocols, technical reports, and summarizing/presenting data.  Additional responsibilities may include presentation of data at internal and external meetings, as well as reports in support of IND/BLA regulatory filings, and supporting collaborations with other groups/sites....

The aim of this job is to support the global Business Process Owner / Head of CoE for the global Learning Solution to establish and maintain a global Learning Solution across the Roche organization, in particular in your area of responsibility. Located in South San Francisco, you provide consultation to the Business in the assigned regions and functions. You work with the local and functional Business Process Owners to ensure that the global processes and standards are embedded in the respective organizations.  In this position, you support the End-to-End Lead in identifying were process and system improvements are required and scope the   initiatives and projects. You are responsible for the delivery of assigned initiatives for your area and across the Roche world in collaboration with the CHRIS LSO servicing and support organizations.

The main responsibilities are:

• Stakeholder management and consultation to the business in the assigned regions and functions:
• North America  
• Latin America
• Middle America
• NAM and LATAM Commercial Operations
• Pharma Manufacturing (PT)
• Diagnostics Manufacturing
• Act as single point of contact for the business, functional and local BPOs
• Gather needs and areas for continuous improvement based on input from the Business,  and address those to the End-to-End Lead and global Business Process Owner / Head of CoE
• Balance local requirements for the assigned area with those of the global and group functions
• Execute the delivery of assigned initiatives (e.g. E2E) across all regions and functions in close collaboration with the CoE and business counterparts
• Liaise with the CHRIS LSO support and servicing organization on new requirements and on the delivery of initiatives
• Enforce the implementation of end-to-end processes locally and functionally (esp. where no dedicated local BPO exists)
• Provide input to global process documentation
• Support change management

...

HCV Sr. Clinical Coordinator
Territory: Philadelphia, Baltimore 

Significant Travel Required

HCV Sr. Clinical Coordinators are responsible for the active promotion of Genentech's HCV product portfolio and focus their attention on key specialty customers and thought leaders. HCV Sr. Clinical Coordinators are expected to deliver on-label messages in support of product indications. HCV Sr. Clinical Coordinators implement programs and tools pertinent to the successful expansion of Genentech's HCV products in the treatment of HCV and other approved indications. The job requires an advanced level of technical and consultative selling skills. HCV Sr. Clinical Coordinators are preferably experienced working in a broad range of customer segments and in accordance with operational polices so as to appropriately influence current and future prescribers of Genentech products. The HCV Sr. Clinical Coordinator function is in a dual capacity through independent efforts and as a team player with the field and headquarters-based staff to ensure sound business strategies and services are being implemented. The HCV Sr. Clinical Coordinator must comply with all sales force promotional guidelines. 

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ALL CANDIDATES ARE ENCOURAGED TO APPLY.  HOWEVER A PREFERRED CANDIDATE HAS BEEN IDENTIFIED

Senior Health Economist (E5)/ Principal Health Economist (E5A)

RESPONSIBILITIES INCLUDE:

-Design, develop, conduct and manage HEOR studies for assigned products and indications in the cardiometabolism or neuroscience therapeutic areas

-Develop, maintain and apply in-depth knowledge of role, including disease state and clinical topics, market/ customer landscape, and emerging issues.  

-Work independently with minimal guidance, direction and mentoring from manager and others to clarify directions and expand knowledge and skills

-Proactively collaboration with various functions including medical directors, commercial, managed care marketing, development and other gMed functions to ensure alignment of activities with key partners and stakeholders

-Develop HEOR strategy for the medical plan for pre-launch and/or post-marketed products.  

-Design and execute prospective and retrospective outcomes research studies, in collaboration with academic consultants and contract research organizations.  -Develop economic models and AMCP dossier chapter to support launch. Manage budgets, timelines and deliverables as planned.

-Lead and/or participate in HEOR and cross-functional projects. 

ABILITIES:

- Demonstrate strong leadership and communication skills; can contribute to the development of vision and strategy in Medical Affairs teams.

- Demonstrate abilities to manage complex responsibilities, to include integration across multiple projects and priorities

-Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrix project team environment

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Senior Manager, Pipeline and Portfolio Planning (PPP) Cross-Portfolio Analysis & Communications 

The successful candidate will be a key member of the Cross-Portfolio Analysis & Communications (CPAC) team within PPP/Pharma Portfolio Management.  The CPAC team provides management with late stage and cross-portfolio information that enables a shared understanding of the portfolio, and robust analytics that offer unique insights on Roche’s direction, strategic alternatives, and ultimately contribute to effective corporate decision-making.

Responsibilities

Representative responsibilities associated with the role are detailed below:

• Develop analytics around portfolio spend, future portfolio projections and “what if” scenarios

• Assess Roche’s performance versus competitors across various R&D-related metrics

• Provide guidance to, and participate in, cross-functional initiatives on R&D productivity, cost and valuation metrics, and long-range planning

• Participate in preparation of quarterly reports for senior management on progress of portfolio and implications

Job Skills and Expectations

• A strong understanding of pharmaceutical/biotech industry, drug development trends, and business strategy 

• Financial acumen and understanding of commercial and development forecasting methodologies

• The ability to analyze and draw conclusions out of large, complex data sets and articulate the key findings to management and functional leaders

• Strong oral and written communication skills

• Innovative mindset and comfort with ambiguity

• The ability to build cross-functional partnerships and engage in (and at time lead) cross-functional initiatives

• A desire to make a difference and commitment and drive to see things through

...

The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes.  Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.

Responsibilities:

The areas of major responsibility include, but are not limited to the following:

• Responsible for the day-to-day operations of the designated Medical teams.

o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules

o Co-leads and facilitates all medical team planning and decision-making

o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.

o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.

o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.

o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics 

o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements 

o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution

• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.

• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc. 

• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution 

• Conducts proactive risk assessment and change control for all assigned projects/programs

• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

...

The Position:
Provide technical support and maintain consistent configuration, implementation, operation and support of an Integration Services Platform – Infrastructure Platforms (monitoring, inventory, automation, etc).

Responsibilities:

• Provides technical support and maintains consistent configuration, implementation, operation and support of a single Integration Services platform including:
• Implements new releases and sets up standards for operational management
• Monitors and resolves problems with Business Application operations.
• Configures and manages development, UAT and production environments.
• Administers and maintains support services.
• Configures implements and optimizes Business Applications.
• Manages incidents, problems, changes and releases
• Tunes capacity and performance
• Coordinates, tests and administers platform Security
• Complies with OLAs and Quality/Validation requirements
• Ensures ITSM framework, processes, tools and SOPs are implemented, utilized and supported end to end

Applies the processes above to the following Integration Services platform areas:

• Monitoring Solutions (NetIQ, others)
• Inventory Management solutions
• Automation and Provisioning solutions (HP Orchestrator)

Key Objectives:

• Business Application Installation and Daily Administration
• Business Application Performance Tuning
• Business Application Availability
• Support to ensure quick incident resolution
• Engineer new release and setup standards for operational management
• Standards and procedures are followed
• Understand and apply ITSM and process best practices
• Understand and comply with applicable ITSM roles and responsibilities
• Provide Support in measuring and continuously improving process performance and adherence to service level / operating level requirements.

...

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

 

Reports to: Division Manager, Franchise Sales

 

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

*Develops strong and long-term relationships with customersin all assigned accounts

*Presents the assigned GNE brands in a professional,compliant, ethical and effective manner; helping external customers understandthe benefits and use of GNE brands

*Monitors operating costs and compliance with territorybudget

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

*Business travel, by air or car, is regularlyrequired 
...

Main Purpose of the Position: Provide direct manufacturing Quality Assurance support to Production (Inspection, Packaging, Aseptic Operations) in a GMP environment. Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support. Assure compliance with cGMP regulations, Roche / Genentech standards, and applicable Regulatory Guidelines. Solve routine Quality Assurance issues limited in scope and complexity following cGMP regulations and Genentech standards. Perform assigned tasks and work to achieve company goals and department objectives. Job Duties/Responsibilities: Follow company policies and procedures. Maintain a state of inspection readiness. Provide input to the development of personal performance goals and departmental objectives. Meet assigned targets and timelines with minimal supervision. Prioritize assigned tasks within a fast paced environment. Participate in process improvement and system design teams. Provide assistance to customers in support of departmental functions. Work with colleagues to maintain cross-functional and cross-site process and procedural consistency. Receive specific instruction and work independently to complete tasks. Apply basic theory and technical principles to address routine problems. Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Sign documents for activities as MQA as described by Genentech policies, procedures and job descriptions. Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies. Perform any other tasks as requested by Management to support Quality oversight activities. Technical Duties/Responsibilities: Perform Inspection and Packaging AQLs. Perform Line Clearances for Inspection, Packaging, and Aseptic Operations areas. Initiate and close discrepancies and child records as required. Review batch records in the Inspection, Packaging, Aseptic Operations areas. Perform Assessor and Evaluation activities in the Discrepancy Management System. Interact with interdepartmental contacts on discrepancy assessment and resolution. Provide Quality oversight to internal and external customers. Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support Quality process improvement initiatives. Support the execution of departmental deliverables assigned by project teams. This is a SWING shift position: Monday, Tuesday, Wednesday, Thursday, and Friday – 4:30pm to 1:30am...

Description:

Genentech's US Biologics Pharma Technical Development organization is looking for an Engineer I to work in our Process Development Engineering group (PDE).  PDE's role is to provide innovative engineering services to the cell culture and purification pilot plants and labs.  PDE also evaluates new automation, robotics, and process sensor solutions for Drug Substance processing.

The Automation Engineer will be expected to support the users and systems in the large scale cell culture pilot plant.  This role will require design, specification, implementation and maintenance of bioreactor control systems for both mammalian and microbial processes.  Key roles and responsibilities include:

• Identification, evaluation and implementation of new technologies to improve the efficiency and safety of control systems at Genentech.

• Maintenance and troubleshooting of hardware and software on the process control systems in the Process R&D Labs and pilot plants.

• Design, implementation and support of laboratory automation systems.

• Leading and supporting small project teams which design develop and integrate automation systems in the Process R&D laboratory and pilot plants.

• Scope of work definition and supervision of contract labor for small and medium projects under the direction of a senior engineer.

• Collaboration with Corporate Engineering, Manufacturing Science and Technology (MSAT) and other business partner groups on technology transfers and information exchanges.

• Author and maintain system support and specification documentation.

• Author technical reports and/or presentations.

• 24/7 on-call support is required for this position.

...

• Develop harmonized approaches to global IMP quality systems and validation related areas and facilitate global implementation for PTDQ leveraging the integrated Pharmaceutical Quality System (PQS).
• Proactively identify, prioritize and assess quality and validation compliance risks across the IMP network
• Facilitate continuous improvement and the sharing of best practices at the various IMP global sites
• Develop solutions to complex Quality Systems and Validation issues and Quality initiatives with inter-organizational impact following cGMP regulations and internal company standards. 
• Provide technical review and approve validation deliverables for small molecules and biologics equipment qualification and process validation/characterization studies, ensuring proper study design and execution.
• Perform tasks and work to achieve company goals and organizational objectives.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Provide guidance to internal and external customers on best practices for generating and executing validation protocols.
• Provide technical assessment and approval for GMP changes.
• Provide input into investigations involving GMP related failures.
• Identify, design, and implement process and system improvements, including contributing to the development of new concepts, techniques and standards.
• Mentor and supervise (as required) other QEV staff members on Validation related, processes and projects.
...

The general purpose of the Senior Manager, Commercial Training & Development role is to help structure and directly manage the development and implementation of appropriate and aligned learning & development in support of assigned functions across Commercial Operations. As such, the Senior Manager, Commercial Training & Development manages a team of assigned trainers, and/or instructional designers and other project-based or administrative staff, and does so to ensure the assigned team meets or exceeds their goals and objectives. 

The Senior Manager, Commercial Training & Development may be assigned core sales, product knowledge, marketing, or other core Commercial Operations functional skills development curricula in support of assigned Commercial Operations functions, or he/she may be alternatively assigned core aspects of a Commercial Operations-wide development segment such as cross-functional leadership or management development. Incumbents in the Manager/Senior Manager, Commercial Training & Development role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. 

As a manager of others, the Senior Manager, Commercial Training & Development is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. 

MAJOR RESPONSIBILITIES ¿

* Has a thorough understanding of the applications and benefits of Genentech's products.

* Determines the most effective approach to meet product learning needs of the business. Applies instructional design principles and adult learning principles to enhance content delivery. 

* Performs detailed needs assessments in coordination with Brand Sales and Clinical Trainers. 

* Translates business needs to training products and programs.

* Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.

* Researches the issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products

* Oversees the preparation of training products and programs such as classes, workshops, learning modules, e-modules, and other job aids and materials for distribution to CT&D partners and program participants.

* Skilled at group facilitation and group learning exercises.

* Implements learning and development programs based on needs assessed.

* Designs and implements metrics to measure training programs and training impact, effectiveness, appropriateness, and utility.

* Filters and distributes educational resources to CT&D partners and other appropriate audiences while remaining

contentious of legal and regulatory parameters.

* Collaborates with all CT&D partners: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure training needs are met.

* Collaborates within CT&D to ensure consistency, avoid redundancy and thereby enhance training programs.

...

The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

 

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to small molecule programs.

 

Responsibilities:

The successful candidate for Scientist will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of small molecule project teams, work closely with Study Monitors, Pathologists, Pharmacokineticists and Pharmaceutics to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired.

...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

The Regulatory Advisor will be responsible for developing global regulatory strategy, writing high quality dossier and leading teams for assigned projects to obtain timely approvals of Roche applications. The Roche Pharma Technical Regulatory leadership team is composed of seasoned technical experts whose focus is to collaborate with Roche Scientists and International Health Authorities to drive development of innovative regulatory policy, and ensure the approval of Roche products developed using novel and efficient process development strategies. This position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.

 

The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support both US ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities will include leading departmental operational excellence and business process initiatives, as well as, proactively communicate with Regulatory and cross functional personnel and partners in support of internal and partner associated goals.

The Regulatory Advisor must maintain a high level of professionalism, efficiency, and commitment. The successful candidate will demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must have a proven ability to communicate effectively in both a written and verbal format. Ability to work both independently or collaboratively in a team structure. Have a proven ability to work well under pressure.  The incumbent will be skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.

...