Therapeutic Area Manager (TAM), Ophthalmology

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver even better health outcomes for patients while lowering overall healthcare costs.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care.

The TAM Ophtha is empowered to own components of the business within their respective ecosystems and to optimize as appropriate; focused on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the business strategy. The TAM will represent all relevant products (LUCENTIS today and upon FDA approval, PDS and faricimab) and indications.

In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient.

In addition, they are responsible for collecting insights and trends for their respective ecosystems and being a conduit between an ecosystem, the Ophtha Squad and marketing to support the national strategy at a local level. The TAM will represent Genentech Ophthalmology products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

Key Accountabilities

1. Serve as one of primary points of contact for ophthalmology customers in the ecosystem. Address and identify opportunities for pulling through ecosystem and Ophtha squad strategies at the point-of-care

2. Apply strong understanding of the specific needs of healthcare practitioners and mobilizes ecosystem and organization experts to partner with customers to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care

3. Contribute to the development and execution of customer account plans for target accounts to deliver maximum impact opportunities and business goals

4. Deliver education to HCPs regarding product information, appropriate use, and dosing and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate

5. Address product acquisition (contract awareness, etc), and address supply matters through coordination of distribution issues, and managing spoilage and returns

6. Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to Ophtha HD and FRM Ophtha as appropriate

7. Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities to increase impact

8. Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials

9. Lead, act and live our Operating Principles in all aspects of work

Qualifications:

● Scientific or clinical degree, Bachelor’s degree level at minimum

● Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required

● 4 or more years experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment

● Knowledge and experience with Ophthalmology and/or Retina is a plus

● Biologics, Injectable and/or buy & bill experience is preferred

● Ability to work in an ambiguous environment undergoing transformation is a strong plus

● Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities

● Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals

● Self starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem

● Ability to assimilate and communicate complex clinical and product information

● Knowledge of and ability to successfully address operational issues in the delivery of healthcare products to patients, such as reimbursement and supply

● Understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech Operating Principles:

I put the patient first, always.

I am obsessed with meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive. 

I build a culture of trust.

I have a growth mindset.

I act with urgency.

I am accountable.

I radically simplify and prioritize for impact.

I follow the science.

I build our reputation.

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

Who We Are:

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.   Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society.  We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide  an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

The next step is yours. To apply today, click on the "Apply for this job" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of 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.

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Purpose 

Experience Operations (XO) is a functional group within Genentech Business Operations (GBO) comprised of experts who partner across Commercial, Medical Affairs and Government Affairs (CMG) to orchestrate and deliver integrated customer experiences that drive measurable business outcomes.

The Social Media Service Lead will be the Product Owner of social media services within XO. They are broadly responsible for ensuring that the social media strategies and capabilities of XO are accelerating the organization’s progress towards delivering great customer experiences and business impact. The individual in this role will be responsible for the Social roadmap creation and execution in partnership with stakeholders, and operations/technical partners. As a product owner for a critical engagement channel this person will leverage a deep understanding of social media, well-rounded soft skills, and a results driven approach to help us devise and deliver engaging experiences with patients and customers.   

Key Responsibilities

• Maximizing Business Outcomes

  • Is the product owner of social media services and is responsible for the overall vision and success of XO social media

  • Synthesize customer and business trends to identify short-term and long-term opportunities for XO social media

  • Develop and execute capabilities roadmaps that allow XO social media to advance customer experiences and campaign performance

  • Define and lead social media service work products using agile methodology to achieve 90 day business priorities and customer strategies

  • Is an active member of the Digital Services leadership team and plays a key role in shaping a performance-driven culture

• Operational Model

  • Accountable for setting portfolio social standards and operating model

  • Ensures standards are documented and relevant stakeholders are trained

  • Accountable for service compliance

• XO and CMG influence

  • Consult, participate and lead CMG work products requiring XO social media expertise

  • Collaborate across XO service teams to achieve business and customer goals

  • Ensure CMG leaders are clear on value proposition of social media capabilities and how it can be leveraged to achieve business and customer goals

• Resource planning and Management

  • Accountable for overall resourcing strategy for XO social media including offshoring

  • Overall budget management for XO social media services

  • Lead contracting strategies for social media specific vendors

  • Manage core team of FTEs/contractors 

• Responsible for service team culture and operating principles

  • Coaches and advises service team members on CMG operating principles

  • Develops a team culture of accountability and adaptability

  • Develops change leadership strategies in support of service evolution

​

Skills & Competencies

• Broad expertise in all aspects of social media including portfolio-level social management, campaign planning and execution, community management orchestration, and customer experience (CX) 

• Experience standing up, building and scaling a social media center of excellence to educate a large, diverse organization on the value of the channel

• Understanding of the importance of social media governance, including account ownership and the structure of social media across a global enterprise

• Experience tying social media marketing metrics to business outcomes

• Expertise in social media marketing strategy and operations, and strong experience in omnichannel marketing

• Ability to apply knowledge of current social trends to Genentech’s business needs and enterprise-level strategy. 

• Growth mindset, looking to continually learn and build expertise

• Experience with change leadership

• Ability to influence and inspire individuals across the CMG network, from front-line employees to executives

• Strong drive for results through agile planning and execution

• Ability to create capabilities plans and design fit-for-purpose solutions

• Budget and finance management; agency management

• Strong customer orientation and mindset

• Goal oriented, ability to clearly define success and relevant Key Performance Indicators

Qualifications & Experience

• Bachelor's degree required, MBA or other related graduate level degree preferred

• 12-15 years of experience in digital media, 5-7 years in social media

• Experience in the managed care, pharmaceutical or biotech industry

• Experience leading teams

• The position is located in South San Francisco, however, will consider remote with travel requirements to the home office

https://www.gene.com/careers/commercial-operating-principles

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Position Overview

The Diversity & Inclusion (D&I) Office, under the leadership of the Chief Diversity Officer (CDO), is responsible for leading the strategy, communication, partnerships, and outreach related to Genentech’s diversity and inclusion (D&I) mission. Genentech embraces the increasingly diverse world around us. Our mission is to be the industry leader to deliver scientific innovations that drive better outcomes for our people, patients, business and communities by advancing and boldly championing diversity, equity, and inclusion.

The D&I Office is seeking a qualified Principal, Inclusion & Health Equity to develop and evolve the long-term strategy for D&I at Genentech, manage external affairs, and lead partnerships externally to establish and grow the D&I Office’s reach. The Principal will partner with external companies, councils, organized customers, policy makers, patients and additional stakeholders to develop solutions that support Genentech’s D&I, health equity, and Enterprise priorities. The Inclusion Principal for External Partnerships will report to the Director of Inclusion Strategy & Partnerships.

This position can be Home Office or Field based.

Responsibilities

• Lead Advancing Inclusive Research (AIR) and Health Equity external partnership strategy, programs, and stakeholder engagement to drive value for diverse patients and customers

• Engage with appropriate think tanks to support research and publication strategies on diversity, health equity and inclusion

• Define and own new external partnerships to expand network of Genentech’s D&I stakeholders, colleagues, and partners

• Build, maintain, and support relationships between key external stakeholders and thought leaders

• Serve as primary conduit to field and medical partners for opportunities specific to diversity, health equity, and inclusion

• Create, sustain, and evolve multi-year strategy to engage external stakeholders to advance Genentech’s D&I mission

• Build External D&I Advisory Council comprised of industry and D&I experts, manage all content for meetings, and serve as point of contact for all members

• Collaborate closely with Internal Partnerships to ensure consistency and engagement across stakeholder groups, including corporate giving strategy

• Develop D&I external strategy alongside the Inclusion Marketing and Communications Senior Manager to advance Genentech’s brand 

• Represent Genentech D&I at various forums, meetings, and/or events as an attendee/participant or speaker, as needed 

The D&I Office is new and evolving. As such, the responsibilities of this role may change over time as the Office is established and continues to evolve.

Core Competencies

• Strategic agility 

• Teamwork and collaboration 

• Drive for Results

• Patient & Customer Centricity

• Business expertise

Minimum Qualifications

• Advanced degree (Pharm.D, PhD, MD, etc.) in relevant field

• 10+ years of relevant experience

• Proven track record of building partnerships between biotech/pharmaceutical companies and nonprofit organizations, societies, and government agencies to advance a shared mission

• Proven ability to shape strategy, anticipating challenges and opportunities

• Demonstrated relationship advancement with external stakeholders over multiple years

• Ability to travel by air or car at least 50%

Preferred Qualifications

• Application of sound judgment, leadership, inclusive behavior, and collaboration

• Experience working with external communities, companies, councils in the D&I space

• Strong track record of publishing and presenting to external audiences, including experience submitting peer-reviewed abstracts and publications

• Experience working effectively in ambiguous, rapidly changing environments

• Extensive experience influencing without authority and negotiation

• Strong written and verbal communication skills

• Critical thinker with strong problem-solving

• Solid organizational skills and detail-oriented

• Ability to work under pressure and meet strict deadlines

• Expert computer skills in word-processing and presentation development 

• Has strong existing relationships in healthcare and is able to leverage them to support new opportunities

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 

Key Accountabilities

• Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
• Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
• Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
• Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
• Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
• Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

• Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
• Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
• Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
• As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
• Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
• Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
• In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
• Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
• In conjunction with the region’s field team:
  • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
  • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
  • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
  • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
• Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
• Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
• Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
• Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
• Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
• This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
• Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
• This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

• Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
• 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
• Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
• Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
• Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
• Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
• Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

CMG Operating Principles

● I put the patient first, always.

● I am obsessed with meeting customer needs.

● I act on behalf of the whole company, not just my team.

● I am inclusive.

● I build a culture of trust.

● I have a growth mindset.

● I act with urgency.

● I am accountable.

● I radically simplify and prioritize for impact.

● I follow the science.

● I build our reputation. 

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

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of 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.

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#medicalaffairs

Responsible for producing innovative bio therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operate and support manufacturing equipment such as the autoclaves to prepare for GMP processing.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsible for being proficient in one functional area.  Understands and applies biological, chemical and mechanical principles and techniques.

• Perform sanitization and cleaning per governing SOPs in Grade A/B GMP spaces.
• Clean, assemble, and sterilize equipment using washers and autoclaves.
• Perform facility FIT walkthroughs and create work orders to fix any issues observed.
• Monitor and perform audits of tasks such as cleaning and pest control operations within classified environment
• Responsible to participate in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering.

• Operate systems that clean and sterilize tanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Troubleshoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
• 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.

• A good working knowledge of biopharmaceutical technology and processes. 
• Trained and skilled in all operational procedures of at least one manufacturing department.
• Demonstrated ability to independently document and record information related to the process.
• Occasionally makes routine decisions based on experience.  Identifies and suggests solutions to common basic problems.
• Recognizes non-routine problems, investigates and suggests potential solutions.
• Judgment is required in resolving problems and making routine recommendations. 
• Ability to recognize deviation from accepted practices is required.

Education and Experience

• High School and 1-3 year related experience working in a GMP work environment
• Biotech certificate from approved program

Knowledge, Skills, and Abilities

• Strong oral and written communication skills.
• Familiarity of computer-based systems
• Background in fermentation
• Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.

• Schedule could include a non-rotating 3 or 4-day (12 hour shift including one weekend day), evening or night hours, or full off-shift hours.
• Expected to be on feet for 8 to 10 hours a day.
• Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
• Lift up to 25 lbs., Carry 25 lbs., Push/Pull force of 50lbs with full body, and Push/Pull force of 24lbs with arms only may be required.
• Ability to bend and lift items from floor level, work with arm extended at chest height while making fine hand and finger manipulations, extend arms above shoulder level to manipulate equipment, and repetitive fine motor skills.
• The clean room environment requires:
  • Gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots must be worn
  • No make up or jewelry can be worn when working in the clean room environment
  • Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
• Work with hazardous materials and chemicals.

This position is a "Locally Remote" position. We are looking for candidates that are local to the Greater Portland area that will be working remotely at this time.

The Foundation Specialist evaluates patient eligibility for Genentech Patient Foundation; actively works with partners, HCPs, and patients for account management, education, and issue resolution; and coordinates with the Foundation's specialty pharmacy and/or distribution centers for shipments to patients and providers. The Foundation Specialist is an Individual Contributor who reports to a Supervisor.

Key Responsibilities/Accountabilities:

• Provides customer-focused support to patients and providers.

• Works collaboratively with peers to move casework forward.

• Assists patients and providers in the enrollment process for assigned products.

• Evaluates patient eligibility across key criteria and communicates determinations.

• Actively supports product launches, line extensions, and formulation changes.

• Embeds a culture of compliance by ensuring self, colleagues, and team members are adhering to laws, regulations, and policies that govern Foundation conduct.

• Periodic mandatory overtime throughout the year is required in Genentech Patient Foundation. This may include, but is not limited to, high referral season, new product or system launches, new line extensions, or any unexpected surge in volume or backlog situations. May include weekends as needed.

Recommended Skills and Experiences:

• Bachelor’s degree is preferred or equivalent experience.

• A minimum of 3 years reimbursement experience is preferred.

• Candidate has the ability to work from home as needed 

• Candidate has the ability to protect patient privacy in a home work environment

• Candidate has a comfortable at home work setup (laptop will be provided, external monitor recommended) 

• Knowledge of the managed care industry, including government payers.

• Proficient in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules).

• Understands reimbursement/funding resources and how to access these resources.

• Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format.

• Ability to work collaboratively in a team structure and responsibly delegate next steps to appropriate team members.

• Demonstrates effective problem solving and excellent customer service. 

• Exceptional attention to detail.

• Able to work effectively under pressure and prioritize tasks.

• Able to follow written Standard Operating Procedures.

Competencies:

• Managing Change

• Teamwork and Collaboration

• Achieving Results

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

This position is currently a "Locally Remote" position. At this time we are having people work from home that are in the Greater Portland area.

The Case Manager acts as a liaison between patients, providers, MDs, distributors and insurance carriers to assure services are provided in the least restrictive and least costly manner.

• Provides customer focused reimbursement support to patients, pharmacists, physicians and internal sales force

• Educates, informs, and assists patients and providers to navigate through the reimbursement process for the assigned product

• Identifies barriers to reimbursement and continually identifies and recommends program efficiencies to the Supervisor to promote high quality of work by Access Solutions/GPF staff

• Identifies and facilitates referrals to alternative coverage options and financial assistance programs for patients who are under insured or require copy assistance

• Establishes relationships with appropriate stakeholders including internal & external partners

• May conduct necessary benefits, coverage and payer research/investigations to ensure appropriate resources, compliance with payer appeal policies, practices, timelines

• Educates, informs and generally assists patients and their families, as well as other related external or internal parties on how to navigate the appeals process

• This position may require some travel and flexibility in the work shift.

• Periodic mandatory additional hours is required 

The successful candidate will demonstrate the following competencies critical to this role:

• Communication – Listens well; expresses ideas fluently and logically; is open to input and can be depended on for truthfulness

• Inspiring and Influencing – Fosters an exchange of ideas and support; persuades and influences without authority

• Teamwork and Collaboration – Creates an atmosphere of openness and trust; collaborates; offers support and encouragement

• Achieving Results – Is goal directed and persistent; is accountable for meeting commitments; recognizes the contributions of peers

Qualifications

• Bachelor's degree is preferred

• Candidate has the ability to work from home as needed 

• Candidate has the ability to protect patient privacy in a home work environment

• Candidate has a comfortable at home work setup (laptop will be provided, external monitor recommended) 

• A minimum of 3 years of reimbursement experience preferred

• Proficient in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules.

• Understands reimbursement/funding resources and how to access these resources.

• Demonstrates effective problem solving skills and provides excellent customer service.

• Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format.

• Ability to work collaboratively in a team structure and responsibly delegate next steps to appropriate team members.

• Must be able to work effectively under pressure and prioritize tasks in a fast-paced environment.

• Must be able to follow written Standard Operating Procedures

• Candidate must have excellent knowledge of the managed care industry, including government payers

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

This position is a "Locally Remote" position. We are looking for candidates that are local to the Greater San Francisco area that will be working remotely at this time.

The Foundation Specialist evaluates patient eligibility for Genentech Patient Foundation; actively works with partners, HCPs, and patients for account management, education, and issue resolution; and coordinates with the Foundation's specialty pharmacy and/or distribution centers for shipments to patients and providers. The Foundation Specialist is an Individual Contributor who reports to a Supervisor.

Key Responsibilities/Accountabilities:

• Provides customer-focused support to patients and providers.

• Works collaboratively with peers to move casework forward.

• Assists patients and providers in the enrollment process for assigned products.

• Evaluates patient eligibility across key criteria and communicates determinations.

• Actively supports product launches, line extensions, and formulation changes.

• Embeds a culture of compliance by ensuring self, colleagues, and team members are adhering to laws, regulations, and policies that govern Foundation conduct.

• Periodic mandatory overtime throughout the year is required in Genentech Patient Foundation. This may include, but is not limited to, high referral season, new product or system launches, new line extensions, or any unexpected surge in volume or backlog situations. May include weekends as needed.

Recommended Skills and Experiences:

• Bachelor’s degree is preferred or equivalent experience.

• A minimum of 3 years reimbursement experience is preferred.

• Candidate has the ability to work from home as needed 

• Candidate has the ability to protect patient privacy in a home work environment

• Candidate has a comfortable at home work setup (laptop will be provided, external monitor recommended) 

• Knowledge of the managed care industry, including government payers.

• Proficient in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules).

• Understands reimbursement/funding resources and how to access these resources.

• Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format.

• Ability to work collaboratively in a team structure and responsibly delegate next steps to appropriate team members.

• Demonstrates effective problem solving and excellent customer service. 

• Exceptional attention to detail.

• Able to work effectively under pressure and prioritize tasks.

• Able to follow written Standard Operating Procedures.

Competencies:

• Managing Change

• Teamwork and Collaboration

• Achieving Results

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

This position is a "Locally Remote" position. We are looking for candidates in the Greater San Francisco area that will be working remotely at this time.

The Case Manager acts as a liaison between patients, providers, MDs, distributors and insurance carriers to assure services are provided in the least restrictive and least costly manner.

• Provides customer focused reimbursement support to patients, pharmacists, physicians and internal sales force

• Educates, informs, and assists patients and providers to navigate through the reimbursement process for the assigned product

• Identifies barriers to reimbursement and continually identifies and recommends program efficiencies to the Supervisor to promote high quality of work by Access Solutions/GPF staff

• Identifies and facilitates referrals to alternative coverage options and financial assistance programs for patients who are under insured or require copy assistance

• Establishes relationships with appropriate stakeholders including internal & external partners

• May conduct necessary benefits, coverage and payer research/investigations to ensure appropriate resources, compliance with payer appeal policies, practices, timelines

• Educates, informs and generally assists patients and their families, as well as other related external or internal parties on how to navigate the appeals process

• This position may require some travel and flexibility in the work shift.

• Periodic mandatory additional hours is required 

The successful candidate will demonstrate the following competencies critical to this role:

• Communication – Listens well; expresses ideas fluently and logically; is open to input and can be depended on for truthfulness

• Inspiring and Influencing – Fosters an exchange of ideas and support; persuades and influences without authority

• Teamwork and Collaboration – Creates an atmosphere of openness and trust; collaborates; offers support and encouragement

• Achieving Results – Is goal directed and persistent; is accountable for meeting commitments; recognizes the contributions of peers

Qualifications

• Bachelor's degree is preferred

• Candidate has the ability to work from home as needed 

• Candidate has the ability to protect patient privacy in a home work environment

• Candidate has a comfortable at home work setup (laptop will be provided, external monitor recommended) 

• A minimum of 3 years of reimbursement experience preferred

• Proficient in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules.

• Understands reimbursement/funding resources and how to access these resources.

• Demonstrates effective problem solving skills and provides excellent customer service.

• Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format.

• Ability to work collaboratively in a team structure and responsibly delegate next steps to appropriate team members.

• Must be able to work effectively under pressure and prioritize tasks in a fast-paced environment.

• Must be able to follow written Standard Operating Procedures

• Candidate must have excellent knowledge of the managed care industry, including government payers

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

This position will be a "Locally Remote" position. We are looking for strong candidates that live in the Greater Portland area that will work from home.

The Intake Coordinator acts as the medium between people and resources, connecting internal and external customers to the necessary information, products, or services. The Intake Team is the first step in the patient's journey with Access Solutions to gain assistance with accessing their Genentech medication. As frontline system experts, we process incoming referrals to ensure patients are enrolled quickly, correctly, and compliantly for all Genentech products. We are committed to excellent customer service and cross-portfolio collaboration so that our patient's experience with Access Solutions is smooth and efficient.

Contract duration: 4 to 6 months

 Job Responsibilities:

• Review data submitted through referral sources.  (90%)
• Perform initial data entry into the Access Solutions system. (90%)
• Prepare hard copy file, generate, and remit referral acknowledgment letter to referring source. (5-10%)
• Provide administrative support to Case Managers miscellaneous clerical tasks.
• Aid and support multiple ongoing department projects, as needed.
• Provide excellent customer service to all internal and external customers.
• Lead, act and live our Operating Principles in all aspects of work.
• This position requires some flexibility in work shift. Regular Business Hours are 6AM-5PM Pacific Standard Time. 
• Periodic mandatory additional hours throughout the year is required in Access Solutions Operations. This may include, but is not limited to, high referral season (Blizzard, Enrollment renewal), new product or system launches, new line extensions, or any unexpected surge in volume or backlog situations. May include weekends as needed.

Competencies:

• Communication
• Decision Making
• Technical and Business Expertise
• Achieving Results

Qualifications:

• Bachelor’s degree is preferred.
• 1- 2 years of experience.
• Candidate has the ability to work from home as needed 
• Candidate has the ability to protect patient privacy in a home work environment
• Candidate has a comfortable at home work setup (laptop will be provided, external monitor recommended) 
• Ability to multitask and exemplary organizational skills.
• Ability to process a high volume of incoming faxes (electronically) by reading and determining where and how filed.
• Knowledge of data entry and basic computer skills.
• Must possess solid teamwork and relationship management skills.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

Contractor-Part Time position-20 hours/week. Duration up to 12 months with possible extensions up to 3 years.

Shifts: Negotiable (i.e. Monday to Wednesday or Tuesday to Thursday)

RESPONSIBILITIES: (Note: This description is not intended to be all-inclusive.)

The Occupational Health Nurse is responsible for planning, implementing and managing health and wellness programs and associated regulatory requirements, as well as supporting the site's overall safety, security and environmental sustainability efforts.

Programs and services managed may include, but are not limited to, the following:

·       Medical Surveillance Good Manufacturing Process (CGMP) Screenings

·       Industrial and Office Ergonomics

·       OSHA Recordkeeping, Workers' Compensation care and treatment of work-related injury/illnesses

·       Electronic Medical Record System (OHM)

·       Occupational health and wellness presentations and trainings for departments

The Occupational Health Nurse responsibilities include the following:

·       Under limited direction, lead the organization's Health Services including occupational health and employee wellness programs, to ensure regulatory and legal compliance and promote employee well-being at work as well as at home.

·       Function as the site's subject matter expert for occupational health and wellness, OSHA recordkeeping, workers compensation.

·       Provide appropriate evaluation and treatment of occupational injuries/illnesses, in consultation with Genentech's outside medical consultant.

·       Perform clinical evaluations, first aid treatment of work-related injuries, and function as a nurse care manager.

·       Routinely interact with employees, management, internal Health Services counterparts, and outside occupational medicine providers in a consultative role, representing Genentech and applying relevant business acumen.

·       Determine real and potential health problems and occupational hazards utilizing data from accident report reviews, OSHA Log, medical case reviews, work-site surveys, and medical surveillance screenings, ergonomic evaluations and injury/illness care.

·       Provide occupational health and wellness-related counseling and education. Develop and lead occupational health and wellness training.

·       Organize and maintain confidential employee medical records including, but not limited to, those in OHM, worker’s compensation state filings, and OSHA recordkeeping/reporting.

·       Possess the necessary communication and technical skills to manage highly confidential employee information and to manage delicate employee health matters such as GMP screening results.

·       The occupational health nurse must also possess the technical and communications skills to track progress on Health Services goals and objectives using relevant and effective program management and monitoring processes (e.g. key performance metrics, indicators and scorecards).

·       Participate as a member of the 24/7 emergency on-call schedule.

EXPERIENCE & EDUCATION REQUIREMENTS:

·       Minimum 5+ years experience in nursing required.

·       Minimum one year in occupational health nursing also required.

·       Valid Oregon license to practice as a registered nurse (RN) or nurse practitioner required.

·       Current Basic Life Support (BLS) certification also required. Certification as occupational health nurse specialist (COHN-S), completion of hearing conservation and/or spirometry courses preferred.

Ideal candidate will thrive on challenge and employee interaction; foster an environment of trust, collaboration and learning, and possess an exceptional ability influence all level of audiences.

Must be a total self-starter with strong analytical and problem-solving skills, be able to multi-task and independently develop and drive solutions to problems.

Must possess strong leadership abilities, effective writing and oral presentation skills, and effective conflict management abilities.

The Position:

The Principal Software Engineer will be a key contributor in a team of 10+ engineers applying extensive knowledge of design principles and practices in the implementation of complex, enterprise-scale software systems. General responsibilities include design concept generation, participating in and leading design reviews, development and testing of the core software stack, and reliability testing. This is a senior role within engineering and an opportunity to influence the architecture and roadmap.

Responsibilities:

• Software Development: This is a hands-on software development position to write high quality software that will perform at scale, be supportable, and be extensible.

• Process & Operations: Builds, maintains, and extends our DevOps toolset to ensure ongoing improvements to team productivity and product scalability; lead team members to design, plan and deliver high quality software

• Leadership: Mentor and develop the team on technical concepts; ensures a culture that values technical excellence together with support and compassion for individuals

Requirements:

• BS in CS, Engineering, or related discipline
• Full Stack Engineer with 10+ yrs. of SaaS based web application (Java) development experience
• Experience in working on web application with high volume traffic
• Experience with at least one queue system such as Kafka, SQS, or RabbitMQ
• AWS experience
• Data Modeling and Design
• TDD
• Cache experience (local and distributed)
• Architecture design experience
• Performance tuning / scaling experience

Roche Information Solutions (RIS) provides integrated digital solutions to deliver on the promise of affordable, high quality, and accessible healthcare. RIS is accountable for the development and delivery of digital solutions, common Diagnostics architecture and data management.  Digitalization in healthcare is of increasing importance to deliver customer and patient value, and shape healthcare.

The Platform team is building the foundation on which a myriad of healthcare and research software applications can be delivered to patients, from the cloud to the lab. The Platform Engineering team is responsible for platform services including the development, testing, deployment and operation of software. In addition, the function will manage the platform onboarding and developer experience.

Roche's single vision is to improve the lives of patients, and the RIS Platform team is dedicated to using the latest cloud software technologies as a means to deliver this vision. If you would rather improve health outcomes for millions instead of helping sell ads on the Internet, this is the job for you!

The Position:

The Software Engineer II is a member of a team of 10+ engineers and will apply knowledge of design principles, practices in the implementation of complex, enterprise-scale software systems. General responsibilities include design concept generation, participating in and leading design reviews for components or features, development and testing of the core software stack, and reliability testing.

Works autonomously or in a small team on specific product features with occasional guidance and in coordination with other team mates.  Establishing an internal network across technical teams.

Your Responsibilities:

• Software Development: This is a hands-on software development position to write high-quality software that will perform at scale, be supportable, and be extensible.

• Process & Operations: Ensure the software stack integrates with our existing CI pipeline and contribute to continuous improvement; independently design, plan and deliver high-quality software

• Leadership: Ensure a culture that values technical excellence together with support and compassion for individuals

Your Qualifications:

• BS/MS degree in Computer Science or directly related discipline

• 2+ years of hands-on industry experience as a software engineer

• Participate in architecture and design discussions to come up with the most effective technical solution

• Have successfully built, deployed, and supported an enterprise-scale web application in the cloud (AWS preferred)

• Ideally have the full-stack experience, with expertise in at least one layer

• Hands-on software development experience in either Java or C++/C# with expertise in at least one

• Hands-on software development experience in JavaScript with a modern MVC framework (e.g. Angular, React, etc.)

• Quick learner with the ability to understand complex workflows and develop and validate innovative solutions to solve difficult problems

• Experience in healthcare is not required, but familiarity with healthcare data and workflows is a plus (e.g. HL7, IHE)

Nice to Have

• Node.js and React.js (Nice to have)

In Roche/Genentech Pharma Product Development (PD) Global Clinical Operations (PDG) we put the patient first. We are on a mission to transform clinical trials so that we can quickly deliver novel medicines to patients while lowering the overall cost to society.

We want you to join us on this mission!  We want you to be part of our passionate, collaborative, global leadership community. We work in service of the broader organization’s needs.  We as one mutually accountable leadership community focus on the work that will have the highest impact to our core mission of helping patients across the industry’s most robust Development portfolio. And we look for ways to help our talented people flow to the work they are most passionate about. If these ideas resonate with you, we want you to be a part of our team.

HOW YOU WILL CONTRIBUTE (JOB SCOPE)

You will provide leadership to diverse competency-based communities consisting of people located in a number of countries and be accountable for PDG activities in support of two or more areas: therapeutic areas (TAs)/disease areas (DAs); enabling platforms (EPs); and countries.

As a Global Clinical Operations Leader you are part of a leadership community operating as:

• Visionaries: Sensing, shaping and communicating a compelling future.
• Architects: Designing open & empowered organizations that enable emergence, prioritization/trade-offs & results.
• Catalysts: Inspiring people and teams, fostering connections & removing roadblocks.
• Coaches: Creating a safe learning environment & building the capabilities of others, regardless of level

WHAT YOU WILL DO:

• DRIVE PATIENT-CENTRICITY (MINDSETS, BEHAVIOURS AND ACTIONS) THROUGHOUT YOUR COMMUNITY by always putting the needs of the patient and the investigator first. Cultivating meaningful peer-to-peer interactions to drive a deeper understanding of patient needs, and in doing so nurture a culture of curiosity to enable faster, simpler and more patient centric ways of operationalizing our studies.
• DRIVE EVOLUTION OF GLOBAL CLINICAL OPERATIONS through the bold pursuit of the Pharma Vision and PDG Shared Purpose. This will be achieved by the provision of servant leadership, the embedding of radically simpler ways to do high impact work, and the successful delivery of the study portfolio and transformational enabling projects.
• INSPIRE AND EMPOWER TALENT by providing leadership in our community, as a visionary, architect, catalyst, and coach (VACC). Inspiring people and optimizing their growth opportunities and capabilities to contribute and operate in the global PD/PDG environment. Drive innovation by identifying new trends and opportunities where our people will create value.
• PROACTIVE STAKEHOLDER MANAGEMENT AND ALIGNMENT by partnering with a broad set of senior stakeholders (across the Roche enterprise), enhancing collaborations, fostering connections, removing roadblocks and obstacles, and applying new ways of working to achieve the Pharma Vision and PDG Shared Purpose.
• PROMOTE AND SUPPORT A QUALITY MINDSET throughout clinical operations and into the work that we do.  Our leaders are proactive in building quality and compliance into everything we do.

WHO YOU ARE:

You are a talented and passionate human. You are inspired by our mission.  And you believe in the principles of;

• Customer-Centricity: Obsessed with meeting the needs of patients & investigators.
• Human-Centricity: Connecting with every colleague as a unique person not a resource.
• Growth Mindset: Always curious and looking for opportunities in each situation & for each person.
• Enterprise View: Leading across Clinical Operations & the broader Enterprise, making connections & sharing ideas beyond. Always seeking the greater good.
• Diversity & Inclusion: Cultivating a diverse and inclusive work environment

At Roche/Genentech, we believe our people are key to our success in bringing novel medicines to patients, and we are fully dedicated to being a great place to work and to providing the services, tools and the environment where everybody feels empowered and trusted and is enabled to uncover their full potential. Come join us and help build a diverse and inclusive organization where patient centricity and patient access is the priority.

#LI-BR1

Senior Vice President

Head of Portfolio Strategy and Management

Genentech Research and Early Development (gRED)

The Senior Vice President and Head of Portfolio Strategy and Management (PSM) is accountable for the Project Team Leadership, Program Management and Resource Planning, and Portfolio Strategy and Planning functions in gRED.  This leader will work closely with the Research and Early Development organizations to drive portfolio strategy and manage portfolio resources in order to generate unprecedented impact for patients. 

The Head of PSM is accountable for enabling effective, efficient, and streamlined Project leadership, Project Management, and Portfolio strategy and planning. The Head of Portfolio Strategy and Management will report directly to the Executive Vice President and Head of Genentech Research and Early Development (gRED), which is an independent R&D division in the Roche Group.  

The Head of PSM is accountable for providing gRED with a project and portfolio decision-making framework and for business management of gRED’s Early Stage Portfolio Committee (ESPC), the project and portfolio governance committee for all gRED projects in early development. 

The Head of PSM is a key member of the gRED Leadership team (gRED LT),  and the ESPC. 

Functional Role: 

• Lead overall gRED Project Team System , including the following key functions (a team of approximately 90 people):

• Project Team Leaders (equivalent to Life Cycle Leaders)

• Program Management and Resource Planning

• Portfolio Strategy and Planning

• Educational and enterprise programs to (i)  increase awareness of overall discovery and development processes and (ii) to cultivate enterprise mindset within gRED’s emerging leaders

Key Accountabilities:

• Lead the Portfolio Strategy and Management group, accountable for providing the structure and framework to track and steer gRED portfolio.

• Accountable for providing the decision making framework to actively steer and prioritize gRED’s portfolio and the related investment across all therapeutic areas, being the business manager  for the Early Stage Portfolio Committee (ESPC) and consolidating portfolio and disease strategies, portfolio prioritization, and analyses to drive strategic decisions for gRED.

• Connect with pRED, Late Stage Development, GPS on cross-Roche strategies and initiatives. Lead strategic planning with key counterparts in the Pharma organization to align strategies and to help with successful transition of global pivotal programs

• Collaborate with gRED Business Operations and Communications to enable portfolio and financial planning, as well as team and people initiatives.

Qualifications and Experience:

PhD or MD is required. 

MBA or equivalent training in business is strongly preferred.

A proven leader with ideally 15+ years in the Pharma and biotech industry, with deep experience in drug development and process management, including:

• Extensive experience in leading drug development teams from early stage through product approval and launch, with clear knowledge of scientific, clinical development, regulatory, and commercialization strategies

• Recognized impact in strategic decision making, planning, and execution for portfolio, projects, and organization

• Exceptional ability to lead functional groups, identify and develop talent, and delegate effectively. Proven capability to lead, motivate, inspire without authority in a diverse, global, cross-functional structure.

• A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a “big picture” innovator who can recognize possibilities 

• Strong, lucid, and influential communicator: exceptional influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders 

• Demonstrated leadership and action in diversity and inclusion

• Excellent collaboration skills and ability to build and connect strong teams and community

• A verifiable record of developing and mentoring excellent leaders

We are looking for a high potential postdoctoral fellow to advance our mechanistic understanding of antibody effector function, so that we can design even better medicines. The project will involve engineering fusion proteins (derived from receptor antigens, antibodies, and FcyR proteins), studying these fusion proteins in cell-based assays, and complementing the biological insights with highly sensitive proteomics workflows. The successful candidate will draw from Genentech/Roche’s extensive collective experience in therapeutic antibody development and collaborate closely between departments including, but not limited to, Protein Analytical Chemistry and Biological Technologies.

Who you are

• PhD in molecular biology, biology, biochemistry, protein engineering, immunology or related fields

• Creative and innovative

• Skilled at molecular biology techniques and mammalian cell culture

• Solid scholastic achievement evidenced by peer-reviewed publications

• (preferred) Prior experience performing gene editing with CRISPR and protein engineering

#LI-PL1

#postdoc

JOB DESCRIPTION – primary duties and responsibilities

• Responsible for submission of high quality CMC regulatory documents to health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
•  Contributing to the timely regulatory approval of Roche products.
• Actively contribute to the success of the technical regulatory team (TRT) objectives.
• Support the development and communication of the regulatory strategy to ensure cross-functional alignment.
• Help ensure cross-functional coordination and escalation, as needed.
• Ensuring cross-functional PTR deliverables (including assignments delegated by TRL) are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
•  Keeping TRL fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.
• Managing regulatory aspects of change control and ensuring appropriate communication to TRT team regarding management of technical changes. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.
• Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
• Supporting TRT team in making clear decisions.
• Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments)
• Support departmental business processes to document and improve best practices and work efficiencies.
• Serving as TRL designate or PTR regulatory compliance representative as requested by representing PTR on site, cross-functional, or leadership teams and boards (e.g., TPT/TDT, RAFT, RAC, GEG, QRB, Quality Council, Quality Leadership Team).
• Coordinate submission as Submission Lead or Section Lead

QUALIFICATIONS

Education :

• Master’s Degree in life science disciplines is preferred; Post Graduate Degree is a plus. Bachelor’s Degree in pharmaceutical industry is also appropriate.

Position Overview: 

The Therapeutic Area Medical Science Liaison (TA MSL) is a credible scientific partner responsible for providing clinical and health economic information related to disease states and the appropriate utilization of Genentech medicines (approved and pipeline). This field-based position will engage with healthcare providers, population health decision makers, and patients within their region(s), to further patient outcomes aligned with the overarching objectives of Genentech. In collaboration with their regional partners, TA MSLs are accountable for co-creating the local medical strategy and delivering for their customers. In addition, TA MSLs may be responsible for covering multiple medicines, as well as engaging in broad scientific discussions around patient outcomes and total cost of care, resulting in rich customer insights shared with key stakeholders across the organization.

Key Responsibilities/Accountabilities: 

• Ensure an end to end customer experience for TA specific customers within the region

• Demonstrate deep scientific expertise about assigned molecules/products, franchise(s) and overall therapeutic area(s) to exchange relevant information and insights with top tier thought leaders and healthcare decision makers within a region

• Build, cultivate, and leverage relationships with key external scientific and medical customers and organizations in their region(s) to ensure strong understanding of evolving healthcare trends across the relevant therapeutic area landscape

• Demonstrate proficiency in topics beyond scientific exchange such as value / cost of care discussions, hospitalizations, risk of progression, drug pricing pressures, reimbursement education, and AE management

• Engage in continuous independent learning within the therapeutic area they represent and actively attend and participate in upskilling programs related to assigned molecules, products, disease states and relevant business topics

• Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures

• Build and cultivate important working relationships across field partners to ensure an enterprise approach when working with customers.  Be accountable to the regional team to shape and execute on local medical strategies within planned timelines

• Depending on regional needs and priorities, may be asked to serve in a Medical Affairs Executive Director (MED) role with specific customers

• Identify and bring insights back in house to Genentech stakeholders through efficient and effective use of CRM system

• Assist with Phase I - IV sponsored and supported clinical trials, health economic outcomes research, other TA specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance

• Share clinical and value-based expertise in the development and management of clinical and scientific communications for customers to include publications, conference data, and educational materials, as well as for internal Genentech communications and materials to be used in training and development activities

• Ensure assigned goals and objectives are met and that assigned projects and other work are completed on time, with high quality, and within budget

Qualification: 

• Advanced Clinical/Science Degree required (e.g., MD, PharmD, PhD, MSN, NP, PA etc.).  BSN with extensive clinical experience may be considered.

Knowledge:

• GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient

• In-depth knowledge of Phase IV/post-marketing drug development is preferred

• Relevant therapeutic area knowledge, dependent on customer base

• Comprehensive understanding of product and safety profiles

• Understanding of managed care, health economics, healthcare reimbursement, managed care customers and the distribution channels relevant to pharmaceutical/biotechnology organizations

• Familiarity with the current legal and regulatory landscape pertinent to the pharmaceutical/biotechnology industry

Required Experience:

• Minimum of 5 years related work experience (clinical, managed care, or industry experience)

• Prior experience as a field medical science liaison is preferred

• 2 or more years’ clinical or health economic research experience (either in industry or in another, related setting) is preferred

• 2 years' experience in therapy area is preferred

Skills:

• Ability to learn other disease or product areas as business needs and product life cycles change

• Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion

• Proven track record of meeting or exceeding objectives and goals

• Strong attention-to-detail

• Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas

• Outstanding business acumen; knows the industry, Genentech's business model and value proposition, key competitors and other marketplace factors/dynamics

• Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills; proven ability to effectively and quickly achieve conflict resolution with affected parties and work in a cross functional environment

• Knows how to summarize and communicate complex information and business objectives in a concise and effective way for important presentations and decisions

• Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities

• In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening)

• Business travel, by air or car, is required for regular internal and external business meetings (up to 70% of time)

• 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

#LI-COMMCG2

Main Purpose of the Position:

This position is part of Genentech’s’ Pharma Technical - individualized NeoAntigen Specific Therapy (iNeST) team based in Hillsboro, Oregon.  iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis.  In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of manufacturing equipment, processes, and the quality approach for this exciting and novel technology.

In this role, you will plan maintenance work, work to schedule Facilities & Engineering activities, and manage Maintenance & Repair Operations (MRO) function for a facility intended to produce medicine on a per-patient basis.   You will serve as the technical expert for maintenance planning including resource management, MRO store management, parts specification and ordering, scheduling in SAP, and supporting the facilities organization.

Responsibilities:

• Work as a Planner with emphasis on maintenance execution, production equipment, calibration, buildings and grounds, security and EH&S. 
• Maintain CMMS (SAP-PM) integrity and perform updates in the maintenance system.
• Maintain inventory of critical parts and consumable materials in support of the facility, utilizing industry standard inventory control practices
• Plan and coordinate routine and non-routine maintenance, repairs and facilities activities.
• Develop department maintenance tasks into maintenance schedules.
• Utilize computerized inventory control system to identify and track MRO parts and materials,
• Process and record purchase orders, perform physical counts of inventory and reconcile actual stock counts to computer generated reports
• Translate work notifications into detailed work plans/work orders to include technical information and materials.  
• Bill of material creation, documentation management for assets
• Develop and implement maintenance strategy consistent with industry best practices, cGMP requirements, and company QA requirements.
• Assist in parts kitting program for preventative maintenance.
• Follow up on completed work plans/work orders to monitor plan quality, resource allocation and equipment performance trends. 
• Collaborate with internal peers and partners, network sites and industry teams.
• Experience in personalized health care environment desired
• Effectively work to manage change, discrepancies and other issues as they arise

Qualifications/Requirements:

• B.S. degree in Technology, Engineering, Management Information Systems, Operations Management, Supply Chain Management or related function (or equivalent work experience )
• Experience in CMMS system, particularly SAP-PM R3 or HANA, or other plant maintenance systems.
• Proficiency in MRO processes and inventory management
• Working knowledge of managing data and business processes.
• Thorough cGMP experience, in particular jin maintenance, calibration, spare parts,
• Demonstrate effective wiring skills including preparing technical reports, revision of technical documentation, and implementation of programs and procedures.
• 5-10 years minimum experience in a pharmaceutical/biotech, industrial / manufacturing maintenance/operations environment.
• Experience with cell therapy manufacturing is preferred
• Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries
• Understanding of biopharmaceutical manufacturing, process equipment, and supporting utility systems.
• Excellent communication, facilitation, and interpersonal skills.

#LI-AD1

#ptcareers

Essential

• Leads advancement in, and application of technological and organizational capabilities, in particular through leadership of projects/initiatives chartered from the PT Technology Roadmap.

• Drives identification, testing and implementation of novel technologies, identify and resolve complex equipment and processing issues toward assurance of manufacturing process consistency across the network.

• Reviews/approves technical assessments, and draft investigation, development, validation, and external publications where appropriate.

• Designs and execute studies and comparability protocols to support drug product manufacturing and distribution operations.

• Contributes to regulatory filings.

• Works closely with PTI and interdepartmental staff to meet department and company goals.

• Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents within one’s functional area.  Fosters a culture of health, safety, and accident prevention.

Supplementary Responsibilities

• Champion self-initiated or assigned site/network projects within the context of company objectives, and justify goals to upper management.

• Provide leadership for cross-functional teams dedicated to process improvement, efficiency and optimization.

• Provide knowledge and training on complex process and equipment technologies to PT partners.

• Presents ideas, project goals, and results across departments, to senior management, and at international meetings.

• Effectively partners with and influences stakeholders without direct solid line authority, and drives technical decisions balancing product, site, and operations views.

Education and Experience

• Bachelor’s, Master’s, or Ph.D. degree in bio/chemical engineering or similar

• 10+ years experience in technology of pharmaceutical industry  

• Strong expertise (technical and/or operational) in drug product manufacturing and distribution relevant unit operations (F/T – fill – inspect – pack – distribute)

• Relevant experience in data science, analytics, IT etc. to drive the concept of smart factory

• Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections is desirable.

Knowledge, Skills and Abilities

• Ability to organize and solve complex problems through the regular use of ingenuity and innovation; consistently demonstrates courage and drive to ensure optimal business results.

• Extensive practical and theoretical engineering expertise in biopharmaceutical manufacturing processes.  Recognized authority in their field.

• Contact with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing upper management on advanced technical matters.  Utilizes an established network for technical issues within the industry.

• Strong organizational and interpersonal skills:  can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources.

• Knowledge of cGMP’s, Health Authority regulations, and Quality Systems.

• Familiarity with computer-based systems

• Ability to work in international/global environment.

* This position can be based out of one of Roche's Drug Product sites in South San Francisco, CA, Hillsboro, OR, Basel, Switzerland or Mannheim, Germany. Eligible for relocation.

#ptcareers

*LI-LE