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Reporting to the Associate Director of Device & Drug Delivery Technologies, the Sr. Manager – Device Development is a technical expert who is responsible for managing the development of OPDC’s combination products, drug delivery device related projects following the requirements of OPDC, US and International Requirements as applicable. The Sr. Manager will be responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. Additional responsibilities include creation and management of product and component specifications, design control documents, engineering protocols and reports and frequent presentations to project teams and management. The Sr. Manager will also be responsible for evaluating, developing, and implementing new and innovative device/delivery technologies, and maintaining expertise in state-of-the-art technologies available in industry and academia. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. The Sr. Manager is a technical expert in the field of combination products & drug delivery devices who can effectively navigate, influence and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. Primary expertise should be demonstrated in engineering, device regulatory, device quality systems (cfr 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The Sr. Manager should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. This position requires 8-12 years of applicable experience in the pharmaceutical, biotechnology or medical device industries. Support the vision for the Device Technology function- Support and implement a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs- Work with the Associate Director Device Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, and Quality Management to support strategies for product and process improvements- Support the development of flexible and compliant product development process. Develop and support the strategic activities of the department:- Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products.- Initiate and manage the development and implementation of policies, procedures, and standards for the Device Technology department.- Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects. Develop and perform the tactical activities:- Ensure efficient transfer of products and on-going product support all products to CMO’s from device perspective.- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.- Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation.- Create, maintain and update device related documents required for regulatory filings and complianceProgram management of Device projects:- Develop project plans and corresponding project managements tools to support the execution of all projects- Manage cross functional teams (including 3rd party resources)- Lead Human Factors Engineering & Usability activities
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes.Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.
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The Travel & Expense Manager will be responsible for the management of all aspects of Travel and Expense administration, including overseeing and ensuring adherence to the Company’s Travel and Expense Policy to drive efficiencies, cost savings and traveler safety. This will include management of our corporate travel management company (America Express), expense reporting system (Concur), corporate-wide American Express credit card program along with other travel vendor relationships and programs.This position will lead in the development, implementation, and execution of travel-related (air, hotel, ground transportation etc.) supplier management strategies to optimize the company’s travel program cost, quality and service levels. It will also manage existing travel-related programs, policies and procedures, supplier negotiations/relations, and provide travel reporting and analysis. The individual will lead key travel initiatives to support the ongoing transformation and continuous improvement by conducting reviews of travel program including processes and travel management system/software. Responsibilities:• Negotiates preferred vendors and manages the implementation of new travel program vendors, including, but not limited to, airlines, hotels, car rental, and travel management companies. Manages relationships and tracks vendor performance through issue database, and leading quarterly vendor reviews. Tracks and maintains metrics on vendor savings and rebates.• Coordinates with key internal stakeholders, including, but not limited to Travel Risk Management, Legal, HR, Finance, Global Mobility and Event Planning.• Assists with the travel portion of the annual expense budget and manages requests from internal and external auditors. Responsible for determining cost transfers and allocations associated with Travel Management.• Provides quarterly and ad hoc training sessions for global travel planners and coordinators. Communicates key trends and issues that may impact RGA’s traveling community.• Create and manage data metrics to track supplier performance and cost effectiveness of travel programs; analyze and report on business performance, make recommendations to enhance program and seek avenues to enhance cost savings and efficiencies for process improvement. Drafts regular revisions of Global Travel Policy and U.S. Travel and Expense Reimbursement Policy.• Participates in special projects, departmental, functional and corporate initiatives, and assignments. Performs other duties as assigned.Internal/External Stakeholders:• Category Business Leaders within the HR, Technical Operations, Travel, Legal, Corporate Services, Marketing and Sales organization • Corporate Meeting Planning• Vendor/supplier base for assigned categories• Senior Leadership Team (C-Level)
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The Associate Director, Marketing Operations reports to the Sr Director, Marketing Operations. This position is responsible for leading strategic and operational projects for OAPI brand teams and Commercial Operations teams including but not limited to; ASSURE, Market Access, and Government Affairs. This position will also have responsibility to lead project management standardization efforts within marketing operations.Strategic Planning and Execution• Create and operationalize business tools and processes to ensure a structured, transparent, and repeatable approach to project management and strategic planning for brand and functional team projects and initiatives.• Assess capability gaps within commercial/ functional teams and guide execution against project plans.• Develop Ops playbooks to memorialize best practices and key learnings (e.g. launch roadmaps, prioritization processes, key presentation structures).• Lead strategic projects and cross functional initiatives for brand and functional teams• Partner with vendors as necessary for optimate project implementation and execution• Lead key operational workstreams to support company wide initiatives such as brand planning, POA planning, etc.• Develop project plans and contingency plans for assigned projectsCross Functional Stakeholder Management• Collaborate with key cross functional leaders and teams aligning on project objectives, providing status updates and ensuring ongoing communication and collaboration.• Lead efforts to facilitate “connecting” intersecting functions, teams or individuals for optimal project outcomes.Executive Leadership Interface• Develop executive update dashboards for status updates• Conduct leadership updates on key projects &initiatives• Evaluate and report brand progress to senior leadership and cross functional stakeholders, facilitate issue resolution to drive towards larger goals
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes.Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.Travel Expectations: 60-80% travel time within assigned territory
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This individual will report into the market access function, but work cross-functionally with sales, brand, trade, business analytics and commercial partners to drive strategic decisions and tactical programs that provide customer value for payers across therapeutic categories and over the lifecycle of products. The development of promotional and educational materials to support the field account executives, and other field personnel is a key deliverable for this function. This position will be responsible for building channel and brand payer strategies, collaborate on creating the value proposition and evidence generation strategy for US payers, segmenting payers, creating personal and non-personal tactics, and managing the related budgets. Additionally, providing insight into strategic pricing plans will be a component of this position. The Assoc Director may also lead strategic market monitoring and expansion projects. The Associate Director in this role must have hands-on payer marketing experience developing winning strategies that drive value and access in complex payer markets. This includes an in-depth-knowledge of payer customer environment, buy-and-bill systems, and an understanding of the evolving reimbursement landscape. They must have worked in a payer marketing role or had relevant experiences that demonstrate strategic thinking, driving results and customer orientation.7-10 years in the pharmaceutical industry with the majority of time in managed markets and marketing.• Understand and educate the organization on market access landscape, channels, and strategieso Develop channel and brand specific marketing strategies and associated tactics to support corporate and brand objectives and execution requirements through all resourced Market Access Field teams.o Develop pull through strategies aligned to market access and brand objectiveso Direct brand specific Market Access market research activitieso Lead market expansion opportunity projects• Lead cross functional market access strategy team to deliver an integrated market access strategy for the corporation while aligning to customer value with each engagemento Develop and maintain value message platform for brando Direct and create the necessary promotional tools that support Account Executive efforts with key customers and pull through of payer opportunities in the field with customerso Manages key Agencies of Record to deliver tools and tactics• Lead budget planning process for Market Access and Manage Market Access Marketing Brand budget resources• Engage and inform commercial partners
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The Senior Product Manager will be responsible for contributing to the strategic development and overseeing tactical implementation of marketing programs designed to drive brand awareness, increase adoption and contribute to the achievement of business objectives for an assigned product in the CNS arena.This position will report to the US HCP Marketing lead. The position requires a highly motivated individual that can work efficiently with cross function partners to ensure strategic alignment and accomplish complex deliverables (i.e. lead brand planning, sample optimization, POA development, brand communications, etc.)• Plan, identify, create and produce HCP promotional materials, programs, and activities needed to support brand strategies to meet business objectives. • Collaborate with alliance and agency partners in the execution of HCP strategic and tactical plans o Agency management – Work with the AOR to develop and deliver all of the tactical elements of the promotional mix • Serve as brand to the field sales teams to drive effective communication of brand priorities and seek feedback to improve marketing tactics• Work with cross-functional team to develop, coordinate, and execute Field Sales Plan of Action (POA) meetings. • Work with market research and analytics to identify and implement metrics to gain market insights and measure performance on brand initiatives and programs.• Effectively drive tactics through the Medical, Legal, and Regulatory approval process.• Monitor products, marketplace, and competitor trends and issues to anticipate/identify threats and opportunities. Make recommendations and develops tactics to respond to threats and opportunities.
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Responsible for the design and oversight of clinical research programs and protocols for OPDC products. The incumbent will also be responsible for the clinical development of CNS compounds at different stages of development. Additional Responsibilities:Develops relationships with key opinion leaders and applies their input to enhance study design and protocols.Serves as a medical/scientific consultant to marketing, research project teams, and regulatory agencies.Establishes the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of drug or medical device product candidates. Interprets results of Phase I-IV investigations in preparation for a new drug.Acts as the signatory on NDA submissions and clinical study and safety documents.Involved in product life cycle management.Oversees the CRO relationship, and provides input into the governance committee.Will help lead and support regulatory filing activities and documentsProvides input into ESP field monitor selection, as assigned. Reviews and approves CVs for ESP monitoring staff.
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The Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Submission specialist will perform the reconciliation of submission dates and assist with site audit requests. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.As a member of the Drug Safety and Pharmacovigilance department, the Global PV Workflow Sr. Associate is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations. The Global PV Workflow Sr. Associate will ensure the uniform and timely processing and reporting of adverse events to regulatory authorities and business partners in collaboration with Drug Safety Operations team members. Global PV Workflow Sr. Associate will participate in the set-up and development of monitoring tools and maintenance of adverse event workflows within Avisso to meet global regulatory reporting requirements. In addition, the Global PV Workflow Sr. Associate will assist with the case readiness for internal and external reports (PSURs, PADERs, etc.). The Global PV Workflow Sr. Associate, will coordinate and monitor the department’s workflow, and assist in special projects as assigned. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting. - Coordinate Safety Operations workflow to ensure timely processing and reporting of adverse events to regulatory authorities and business partners- Generate and use established reports to monitor daily case workload and reports due, working with team members to identify potential bottle necks or resource gaps and coordinate work plans accordingly- Generate and use established reports to monitor action items, reports worklist and additional worklist as needed.- Participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures- Assist in the ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.) - Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports- Review adverse event information received for completeness and consistency, initiate case follow-up activities/AE query management, and independently generate narratives in accordance with department processes- May perform quality control activities to ensure complete and accurate case information has been entered into the drug safety database- Follow company processes and guidelines for case management and closure activities, and adhere to company templates and guidelines for documentation and communications- Ensure compliance with corporate and departmental standard operating procedures Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within PV Operations.- May assist in the preparation of ICSR health authority responses - May manage department staff- May distribute completed regulatory reports - May provide support and back-up to the submission function- Perform other activities as directed by Drug Safety and Pharmacovigilance management- - Drafts safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports- Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks- Provides training on the technical and operational aspects of programs to GPV team members (and other OPDC staff as appropriate).- Communicates product safety issues to team members in a timely manner.- Utilizes regulatory and GCP knowledge to assist team members in the assessment of adverse event reports- Represents GPV at interdepartmental team meetings- Represents GPV at meetings conducted with licensing partners, agents, CROs, and clinical site investigators- Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues- Reviews and provides input on protocols, case report forms, investigator brochures, package inserts, and NDA/PLA documentsContributes to presentations, discussions, and data summaries on safety issues at meetings with external groups such as licensing partners, agents, contract research organizations, independent safety monitoring committees, and clinical site investigators
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Otsuka is seeking an Associate Director, Global Clinical Development for our Rockville, MD or Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of Cardio-renal, Metabolic and General Medical products at different stages of development for a global health-care market.The specific duties assigned to the Associate Director, Global Clinical Development include the following:- Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.- Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.- Authors program strategies (i.e., the GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates. Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.- Acts as the signatory on NDA submissions and clinical study and safety documents.- Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.- Provides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committees.- Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.About our Global Clinical Development Team:OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. Our team is collaborative, innovative with a mantra of “acting as though the company was our own.” Our responsibilities range from due-diligence evaluations, where we stress-test others’ development plans, to development and implementation of our own global development & commercialization plans (GDCP). The GDCP translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials. Its goal is to efficiently evaluate the product’s potential and probability of success, support an effective commercial launch and plan for meaningful innovations to improve or expand the value of the initial product for our global customers (patients, prescribers and payors).
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Otsuka is seeking a Director, Global Clinical Development for our Rockville, MD or Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of Cardio-renal, Metabolic and General Medical products at different stages of development for a global health-care market.The specific duties assigned to the Director, Global Clinical Development include the following:- Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.- Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.- Authors program strategies (i.e., the GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates. Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.- Acts as the signatory on NDA submissions and clinical study and safety documents.- Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.- Provides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committees.- Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.About our Global Clinical Development Team:OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. Our team is collaborative, innovative with a mantra of “acting as though the company was our own.” Our responsibilities range from due-diligence evaluations, where we stress-test others’ development plans, to development and implementation of our own global development & commercialization plans (GDCP). The GDCP translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials. Its goal is to efficiently evaluate the product’s potential and probability of success, support an effective commercial launch and plan for meaningful innovations to improve or expand the value of the initial product for our global customers (patients, prescribers and payors).
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Territory: Southwest (preferred location is in the central part of the USA near a large metro area) To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes. This position will cover cross-therapeutic areas within the company.- Insights: collect and submit field medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions- Solutions: identify opportunities for solutions within territory that improve patient outcomes; deploy and apply solutions through direct customer interactions- Healthcare Systems & Trends: maintain a comprehensive knowledge of territory, the interconnectivity of the key decision makers within and the challenges faced in providing and delivering optimal patient care- Economic Value: communicate and deliver pharmacoeconomic data (including quality, cost and patient outcomes) that address payer and provider needs and priorities; including implementing practice decision support and care management tools that positively impact the delivery of patient care- Compliance: conduct all interactions with healthcare professionals, payers and other stakeholders in accordance with all applicable Otsuka policies and procedures.
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The Medical Information Associate Director is responsible for managing all Medical Information activities within a given brand. This position will be responsible for overseeing the development and maintenance of a current and comprehensive medical response database. This position will also collaborate and communicate with Medical Affairs staff, participate in cross-functional meetings, and contribute to group discussions. Key Job Responsibilities:- Provides strategic direction in developing/maintaining a current and comprehensive medical response database.- Participates in the approval process for custom and standard inquiry responses to assure that all responses for a given brand are accurate, relevant and timely.- Provides guidance to other medical information personnel on appropriate searching, review and interpretation of scientific data.- Remains current on all published and ongoing data for a given brand and subsequently performs a critical analysis to determine relevance of that data for inclusion into standard medical responses.- Assists in the development/enhancement and implementation of policies, procedures, and processes for the department- Develop/maintain metrics on Otsuka products to monitor Medical Information inquiries.- Assist in the management of medical information vendors/consultants.- Provides product training to the contact center and collaborates with the contact center as needed for a specific brand.- Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise- Receives, documents, and responds to written medical information requests- Ensures completeness of responses and communicates them professionally.- Evaluates, analyzes, and responds to issues in an accurate, balanced, and timely manner according to Product Information and Corporate Standard Operating Procedures (SOP).- Limits corporate liability by meeting the medical ethical and legal responsibilities of providing product/device related information.- Serves as an educational resource to both internal and external customers.- Recognizes and gathers, according to FDA guidelines and company policies, initial information regarding any adverse events or product complaint reports of which made aware during the handling of medical information and medical device inquiries.- Contributes to interdepartmental projects, and supports the provision of medical, scientific and technical information regarding Otsuka products.- Attends external medical conferences to represent Otsuka Pharmaceutical Development & Commercialization, Inc and staffs the Medical Information Booth as needed.Travel (approximately 15%)
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The CISO position requires a visionary leader with sound knowledge of business management and cybersecurity technologies covering the corporate network and the broader digital ecosystem. As the organization's senior IT security officer, the CISO has enterprise-level responsibility for all data/information security policies, standards, evaluations, roles, and organizational awareness. The CISO is responsible for the establishment and overall management of the information security program for the company, and must proactively work with business units and ecosystem partners to implement practices that meet agreed-on policies and standards for information security. He/She must understand Information Technology and oversee a variety of cybersecurity and IT related risk management activities necessary to ensure the achievement of business outcomes.The CISO should understand and articulate the impact of cybersecurity on (digital) business and be able to communicate this at all levels of the organization, up to the board of directors. The CISO serves as the process owner of the appropriate second-line assurance activities not only related to confidentiality, integrity and availability, but also to the safety, privacy and recovery of information owned or processed by the business in compliance with regulatory requirements. The CISO understands that securing information assets and associated technology, applications, systems and processes in the wider ecosystem in which the organization operates is as important as protecting information within the organization's perimeter. A key element of the CISO's role is working with executive management to determine acceptable levels of risk for the organization. • Develop, implement, maintain, and monitor a comprehensive strategic information security program to ensure that appropriate levels of confidentiality, integrity, availability, safety, privacy and recovery of information assets are met• Provide leadership through strong working relationships and collaboration to develop strategic goals for information security compliance and risk mitigation• Liaise with external partners as necessary to ensure the organization maintains a strong security posture against relevant threats and advancing threat landscape• Develop a KPI, metrics and reporting framework to measure the efficiency, effectiveness, and continuous increase in the maturity of the information security program• Lead and coordinate the development and maintenance of information systems security policies, procedures, standards, and guidelines in compliance with corporate, federal and state laws and regulations• Develop and maintain the Computer Security Incident Response Plan. Provide hands on leadership of the C-SIRT team to contain, investigate, and prevent future breaches of personal or confidential information• Identify and assess risks in implementing business innovations. Provide assessment of those risks to business stakeholders• Design and execute penetration tests and security audits• Monitor compliance with the organization's information security policies and procedures among employees, contractors, alliances, and other third parties• Oversee the development and implementation of training programs and communications to make systems, network, and data users aware of and understand security policies and procedures• Work with legal, risk and compliance staff to ensure all information owned, collected, and controlled by or on behalf of the company is processed and stored in accordance with applicable laws and other regulatory requirements. Collaborate and liaise with privacy officer to ensure that data privacy requirements are included in the security program• Stay well-informed of best practices in the IT security field, coordinate and/or evaluate new and emerging security practices and technologies, and recommend and promote adoption as appropriate• Work closely with Information Technology, and the Security Operations Center (SOC) to identify cybersecurity risks and develop remediation strategies• Inform IT security architecture to include engineering best practices for security controls• Manage an information security risk mitigation plan based on sound risk analysis • Develop and mature the organization’s security assessment program. Perform regular security assessments of effectiveness of policies/procedures and systems security safeguards• Ensure the timely remediation of security vulnerabilities within the environment and produce compliance KPIs;• Consult IT and technical teams on addressing security risk, providing security information and input to strategic and tactical planning, and the appropriate and effective use of IT resources;• Implement, manage and enforce information security directives within regulatory mandates to protect PHI, including Federal HIPAA and HITECH and any applicable state laws.• Cooperate with the regulatory bodies in any lawful compliance reviews or investigations related to patient health information security• Support compliance through participation in regulatory compliance and information security committees• Serve as the information security lead on the Privacy Council; • Build external relationships to identify external cybersecurity threats impacting the industry and influence threat intelligence sharing. • Monitor changes in legislation and accreditation standards that affect information security.
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- Ensures the Customer Service, Technical Support, and Materials Management departments are operating efficiently and effectively by providing the highest level of support to the MDD and its customers.- Develops operating budgets and operates business unit within the assigned expense budget.- Maximizes the effectiveness of internal and external resources to meet business objectives.- Assures that manufacturing and distribution partners meet their commitments to OAPI and vice versa.- Develops contracts with business partners occasionally.- Manages product inventory by working with business units and distribution centers to ensure current and future anticipated customer needs will be able to be met and delivered in a timely manner.- Communicates and addresses problems with contracted suppliers and advises management on potential supply issues.- Develops SOPs and internal training documentation where necessary.- Provides final approval on product/process documentation.- Develops and implements programs geared toward improving customer satisfaction, productivity and reducing costs.- Works closely with Marketing and Business Development to support the deployment of next-generation products and ensure future product serviceability.- Implements new processes for new products as they become available
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Lead the strategic development and tactical execution of HCP personal promotion plan. Collaborate, align, and coordinate with sales leadership/field sales, HCP multi-channel marketing, promotional medical education, consumer marketing, alliance partner, cross-functional partners, and external agencies to deliver appropriate tactical mix on time and within budget. Develop and deliver a clear communication and implementation plan for all tactics. Ensure alignment with Alliance partner on all strategic and tactical efforts. Manage and mentor two direct reports who will assist in all tactical level responsibilities associated with HCP personal promotion. This position will report to the Director, Brand Lead. Individual should have a proven track record that demonstrates breadth and depth across marketing competencies and achievement of performance objectives. Strong leadership skills are necessary to lead/contribute to overall sales execution of key deliverables and make an immediate impact. Experience working with cross-functional teams; e.g., Sales, Training & Development, Business Analytics, and Legal/Medical/Regulatory Review Committees (PRC), is required. Ability to work with a sense of urgency, manage ambiguity and lead through dynamic competing internal/external demands is also required. ● Developing HCP personal promotional strategy, aligned with brand strategic imperatives, and executing corresponding tactics that are impactful, compliant, and within budget:○ Strategic planning and tactical content development and deployment, from conception to execution and evaluation○ Working closely with legal, medical, & regulatory partners to ensure all field-delivered promotional resources are reviewed and approved by the Promotional Review Committee (PRC), resulting in compliant and impactful deliverables○ Consistently monitoring project budgets, expenses, and timelines; demonstrating strategic focus and critical thinking to ensure optimal use of limited resources○ Working with Business Analytics partners (both primary and secondary research) to ensure pull-through of customer insights and market research findings to HCP strategy, messaging, and resources○ Working closely with Alliance partner to ensure alignment on all promotional efforts ○ Managing HCP creative Agency of Record (AoR)● Working closely with sales training and development on all salesforce related training materials for new marketing resources and for training content at POA meetings● Collaborating with sales and sales leadership in identifying needed selling resources, customer concerns, and competitive threats. Developing resources in conjunction with sales and ensuring a consistent feedback loop to gain opportunities for enhancements and to monitor effectiveness● Managing, directing, and mentoring two direct reports who will assist in all tactical level responsibilities associated with HCP personal promotionAssisting brand leadership in development of annual strategic and tactical plans, and accountable for providing project updates to senior leadership committe
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The CISO position requires a visionary leader with sound knowledge of business management and cybersecurity technologies covering the corporate network and the broader digital ecosystem. As the organization's senior IT security officer, the CISO has enterprise-level responsibility for all data/information security policies, standards, evaluations, roles, and organizational awareness. The CISO is responsible for the establishment and overall management of the information security program for the company, and must proactively work with business units and ecosystem partners to implement practices that meet agreed-on policies and standards for information security. He/She must understand Information Technology and oversee a variety of cybersecurity and IT related risk management activities necessary to ensure the achievement of business outcomes.The CISO should understand and articulate the impact of cybersecurity on (digital) business and be able to communicate this at all levels of the organization, up to the board of directors. The CISO serves as the process owner of the appropriate second-line assurance activities not only related to confidentiality, integrity and availability, but also to the safety, privacy and recovery of information owned or processed by the business in compliance with regulatory requirements. The CISO understands that securing information assets and associated technology, applications, systems and processes in the wider ecosystem in which the organization operates is as important as protecting information within the organization's perimeter. A key element of the CISO's role is working with executive management to determine acceptable levels of risk for the organization. • Develop, implement, maintain, and monitor a comprehensive strategic information security program to ensure that appropriate levels of confidentiality, integrity, availability, safety, privacy and recovery of information assets are met• Provide leadership through strong working relationships and collaboration to develop strategic goals for information security compliance and risk mitigation• Liaise with external partners as necessary to ensure the organization maintains a strong security posture against relevant threats and advancing threat landscape• Develop a KPI, metrics and reporting framework to measure the efficiency, effectiveness, and continuous increase in the maturity of the information security program• Lead and coordinate the development and maintenance of information systems security policies, procedures, standards, and guidelines in compliance with corporate, federal and state laws and regulations• Develop and maintain the Computer Security Incident Response Plan. Provide hands on leadership of the C-SIRT team to contain, investigate, and prevent future breaches of personal or confidential information• Identify and assess risks in implementing business innovations. Provide assessment of those risks to business stakeholders• Design and execute penetration tests and security audits• Monitor compliance with the organization's information security policies and procedures among employees, contractors, alliances, and other third parties• Oversee the development and implementation of training programs and communications to make systems, network, and data users aware of and understand security policies and procedures• Work with legal, risk and compliance staff to ensure all information owned, collected, and controlled by or on behalf of the company is processed and stored in accordance with applicable laws and other regulatory requirements. Collaborate and liaise with privacy officer to ensure that data privacy requirements are included in the security program• Stay well-informed of best practices in the IT security field, coordinate and/or evaluate new and emerging security practices and technologies, and recommend and promote adoption as appropriate• Work closely with Information Technology, and the Security Operations Center (SOC) to identify cybersecurity risks and develop remediation strategies• Inform IT security architecture to include engineering best practices for security controls• Manage an information security risk mitigation plan based on sound risk analysis • Develop and mature the organization’s security assessment program. Perform regular security assessments of effectiveness of policies/procedures and systems security safeguards• Ensure the timely remediation of security vulnerabilities within the environment and produce compliance KPIs;• Consult IT and technical teams on addressing security risk, providing security information and input to strategic and tactical planning, and the appropriate and effective use of IT resources;• Implement, manage and enforce information security directives within regulatory mandates to protect PHI, including Federal HIPAA and HITECH and any applicable state laws.• Cooperate with the regulatory bodies in any lawful compliance reviews or investigations related to patient health information security• Support compliance through participation in regulatory compliance and information security committees• Serve as the information security lead on the Privacy Council; • Build external relationships to identify external cybersecurity threats impacting the industry and influence threat intelligence sharing. • Monitor changes in legislation and accreditation standards that affect information security.
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The Otsuka Talent & Leadership Consulting team aims to develop a rare and engaging culture made of unconventional talent. We believe a culture that defies convention will enable the business to leap forward past competitors while providing value to our patients and customers. The Talent & Leadership Consulting team serves as internal consultants that aim to challenge traditional ways of recruiting, managing performance, and developing employees with fresh new approaches.The Sr. Talent Partner, Talent Transformation Projects, will lead efforts to design and deliver key solutions that have been prioritized as part of our Otsuka “Fit for the Future” talent strategy.Just like our ever changing business environment, this role is not static and the Sr. Talent Partner will exercise agility and contribute to other areas of our HR strategy as needed. In addition, the Sr. Talent Partner will be expected to share his or her perspective, ideas, and creative recommendations that address new opportunities and gaps. This role is an important contributor to the implementation of talent and leadership development strategy and is encouraged to define new ways of contributing value to the team and Otsuka. Key Job Responsibilities: - Design, implement, and embed a talent capability building strategy that will drive value for our organization over the next 5 years- Work with the head of Talent and Leadership Consulting and peers to lead transformation projects related to Talent Acquisition, talent management, global harmonization, and executive development- Be an ambassador of the Otsuka culture- Be “in the know” with the latest research and trends that could inform Otsuka development and talent strategy (e.g. external resource gathering, networking with thought leaders, etc.)- Roll up sleeves and manage execution of talent initiatives with a focus on outcomes- Manage vendor relationships and internal stakeholder participation in the design of talent initiatives- Partner with talent team colleagues to deliver impactful talent management solutions to the organizationUnconventional Thinking- Willing to un-learn entrenched ways of doing things and is coachable- Thinks strategically; intuitively makes connections and associations- Has an eye for detail and design.- Strong interest in working in a rapid and entrepreneurial environmentExecution & Outcomes:- Strong action orientation – able to execute on ideas and execute against clear plans with autonomy- Skilled in adult learning principles and instructional design- Great organizational instincts and observant of culture dynamics- Communicates effectively; engaging workshop facilitator- Stellar presentation skills (e.g. powerpoint communication)- Analytical and comfortable using data and technologyAgility- Ability to adapt and learn on the fly (learning agility)- Deals with ambiguity and is able to change directions when neededDiversity of Thought- Humility- Is motivated when working with others- Great amount of EQ and interpersonal savvy
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We are a company that believes in performance excellence, which is based on a framework of Performance, Leadership, and Continuous Improvement. We will accelerate our sales growth through the leadership and development of our people to outperform the competition. Position Summary:The Renal Account Manager contributes to OAPI’s overall sales objective by performing assigned sales related activities. Provides hospitals, physicians, pharmacists and healthcare providers with products, services, and information that will enable them to use and prescribe OAPI products safely and effectively.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:- Think differently by challenging conventional thinking- Are intellectually curious and life-long learners- Are effective, ’get it done’ and have a sense of ownership- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect- Are remarkable in their chosen fieldKey Job Expectations/Responsibilities:- Ensures full compliance with drug laws, regulations, and OAPI policies in all aspects of interactions with healthcare professionals- Achieves the assigned sales objective for the territoryEffectively manages the formulary process to ensure product acceptance to assigned hospital accounts by establishing credibility with key hospital stakeholders, performing timely formulary review for products, expediting formulary acceptance of product, implementing effective plans for product pull-through, and organizing in-services to communicate appropriate approved product information to appropriate hospital personnel on all shifts- Attains the designated goals for calls on appropriate accounts and healthcare professionals- Communicates balanced, accurate, and complete information on OAPI products- Executes calls on pharmacists in order to provide product information and to ensure the availability of OAPI products in assigned accounts within the territory- Collaborates with market access team for formularies and product availability- Demonstrates consistent completion of all administrative requirements in a timely manner, including call reporting, budget management, log-ins, etc.- Completes all required training courses and continually updates product knowledge- Assists district manager in training new Renal l account managersCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities
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The District Sales Manager is advanced in their demonstration of sales and leadership proficiencies. They are active participants in recruiting, hiring, training and development of Account Managers to meet and exceed sales goals and other sales-related objectives.The successful Manager will lead their teams in the accomplishment of these objectives through coaching and feedback, enabling them to increase the market share of the company's products. This leader is fully self-sufficient and able to apply skills successfully in all situations.Knowledge, Skills, Competencies, Education, and Experience:Business Plan Development and Execution:- Attains the assigned sales objectives for the District and ensure achievement of designated goals for sales calls. Through the development of a local customized plan that meets the needs of the unique district market while staying aligned to organizational priorities.- Ensures effective execution of the tactical and operational segments of the sales plans for all marketed products by the District’s representative staff.- Actively participates in evaluation and refining of promotional strategies, business plans, and sales forecastsPeople Development:- Execute District plans for deployment, including recruiting, hiring, training and development of Account Managers- Provide on-going coaching through a consistent framework that allows for mutual identification of performance opportunities and dynamic action plans including follow up that measures progress towards agreed upon goals and expectations of competency- Demonstrate flexible approach, employs distance coaching to increase quality coaching touch point frequency- Develop Account Manager talent pool for higher levels of responsibility or deepen expertise and proficiency in their chosen therapeutic area- Differentiate performance, provide feedback, and proactively address performance issues- Plan and facilitate district meetings and participates in training, POA, and national meetings as requiredBudget Management:- Develops operating budgets for District’s assigned representatives, operates District in assigned expense budget- Monitors individual operating budgets and ensures team operates within budget- Works with internal partners to validate market trends and develop plans and tactics- Purposeful and ongoing collaboration to ensure successful execution and pull through of local tacticsInternal / External Partnerships:- Coordinates the deployment of personnel and resources in an effort to maximize opportunities- Coordinates with alliance partner sales management team within district geography on development and execution of sales plans- Coordinates staffing of exhibits and connections occurring within the area of responsibilityCustomer Management:- Manages key account coordination along with the Account Manager to develop relationships leading to increased profitability and better patient outcomes- Represents OAPI before selected customers (e.g. key customer’s and customer groups)- Utilizes local opinion leader relationships to stay current on dynamics and emerging influences that may impact Otsuka product portfolioCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with letter and spirit of all State and Federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to promotional activities- Identification of risks and issues associated with non-compliance and implications of regulatory infractions
