Reimbursement dossier and negotiation responsibility
Lead cross-functional development of reimbursement dossier strategy and ensure internal pricing strategy alignment and approval
Prepare and submit compelling reimbursement dossiers including NA / GÄL / LOE / APD / PEG / Delisting / 3yPI / PM using local and international data and insights
Lead negotiation of dossier with Federal Office of Public Health in order to achieve fast, broad and sustainable access for our patients
Strategy and budgeting responsibility
Co-develop overall reimbursement strategy taking into account BMS internal requirements, external framework and competitor landscape
Plan for optimal submission timelines for BMS-portfolio
Forcast with cross-functional various budget scenarios
Shape the Pricing & Reimbursement environment
Understand Swiss P&R framework and anticipate health policy trends and its implications for BMS in order to accelerate access for our patients
Actively shape future reimbursement framework through collaborating with national policy/access stakeholders and ensuring BMS perspective is represented at Interpharma in order to ensure that patients have continued, broad and fast access
Inform, educate and collaborate with all BMS functions on Swiss pricing and reimbursement framework and integrate local P&R strategy in company strategy
Key Stakeholders/Contacts – describe this position’s key internal matrix relationships and key external stakeholders/clients
Key internal stakeholders:
MA Lead & Market Access Team
Medical Advisors and Medical Director
Regulatory Manager and Regulatory Director
Product / Brand Manager and Business Unit Director
HEOR Experts (WIG/ ECPM) & key experts in all for BMS relevant therapeutic areas
University degree in sciences/medical or health economics
Market access or payer experience with relevance for P&R and proven success record, preferably Swiss system
Strong analytical skills
Strong project management skills
Strategic pricing & reimbursement leadership
Efficient goal-oriented and self-dependent working style
Basic health economic knowledge
Data management/quantitative analytics capabilities and the ability to transform insights into actionable value models and messaging
In depth knowledge of the Swiss P&R process and the legal-frame work and stakeholder environment
Excellence in cross-functional matrix working
Strong communication and negotiations skills in required languages
Collaboration with all relevant parts of the BMS organization, based on effective teaming and an integrated data/ value demonstration strategy
BMS BioPharma Behaviors required
Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.
· Primarily responsible for manufacturing utility systems including glycol, process waste, clean-in-place (CIP), and others.
· Issue or contribute to safety permits and job hazard analyses (JHAs) to ensure the safe execution of projects or maintenance activities.
· Manage engineering projects to improve plant utility systems. Seek out and apply novel engineering approaches.
· Coordinate projects and maintenance activities with operations in order to minimize disruption.
· Provide technical guidance for maintenance technicians, outside service providers, and operations users.
· Engage with Facilities & Engineering (F&E), Global Engineering, and external resources to engineer solutions.
· Review and approve drawings and other technical documentation to ensure that it remains current.
· Ensure compliance of GMP critical utilities with GMPs, industry best practices, and BMS directives.
· Investigate adverse trends, and implement corrective actions.
· Create or contribute to quality plans that ensure orderly service interruptions and smooth return to service.
· Collaborate with other functions such as quality assurance or safety to resolve compliance issues.
· Remain informed about the current industry practices and guidelines for critical utilities.
· Respond to unplanned outages in order to minimize disruption to manufacturing operations.
· Serve as a site SME for critical utility systems and interact with regulatory authorities or internal auditors. Ensure inspection-readiness of key systems. Develop responses and action plans to correct any deficiencies.
· Leverage appropriate resources from our site integrated facilities management (IFM) provider.
· Identify continuous improvement, energy conservation, and cost savings opportunities.
· Apply modern reliability concepts to ensure effective maintenance and prevent failures.
· Maintain and revise standard operating procedures (SOPs) governing system operation and maintenance. Train in-house technicians and contractors as required.
· Bachelor of science degree in Engineering.
· Knowledge of pharmaceutical utility operation, cleanrooms, and building systems.
· Experience with (or ability to learn) Maximo CMMS, Ariba purchasing, and SAP cost center functions.
· Demonstrated ability to work across organizational boundaries to resolve a range of technical and compliance issues.
· Strong technical knowledge in a focus area such as pharmaceutical water systems, HVAC, or electrical engineering.
· Experience safely managing multiple projects and balancing priorities.
· Strong analytical and problem solving skills, especially as applied in a team environment.
· Willingness to provide on-call, off-hours support as needed to assist with planned activities or respond to unplanned problems.
· Understanding of applicable regulations (GMP, OSHA, DEC, etc.). Familiarity with quality systems governing GMP utilities (change control, SOPs, investigations, CAPAs).
· Familiarity with modern maintenance management and reliability concepts.
· Ability to compose sound technical and compliance documents, including thorough investigations, meaningful corrective action plans, and justifiable change controls.
· Ability to articulate complex technical issues and communicate in a variety of forums to stakeholders and site leadership.
· Experience working in a GMP environment is a plus.
Seeking an experienced Clinical Research encoding specialist to be responsible for the management of industry standard terminologies (MedDRA, UMC WHO-Drug) along with the oversight of coding for major project or programs.
Responsible for delivering accurate and consistency medical coding for all assigned protocols within established timelines and in compliance with all processes, guidelines and conventions.
Oversight of the review and approval of coded terms in clinical trials designated for coding with MedDRA ensuring that coding is clear, appropriate and complete based upon the investigator’s entry on the CRF and in compliance with all processes, guidelines and conventions.
Establishes and maintains communications between GPV&E, clinical and vendors to ensure MedDRA mapping consistency between AWARE, TMS and CRO systems.
Establish and enforce the versioning strategy and timeline for routine version updates for industry standard dictionaries (MedDRA, UMC WHO-Drug).
Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution.
Perform periodic review of industry best practices and BMS coding guidelines to ensure alignment.
Assist with development and update of Medical Encoding best practices, SOPs and coding process documents.
Assist with the development; creation and maintenance of company specific Standardized MedDRA Queries.
Knowledge of general clinical research and of the pharmaceutical industry. Thorough understanding of
Regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.
Must Have Requirements:
Minimum of 5-7 years coding in clinical research and of the pharmaceutical industry
Knowledge equivalent to that attained with a Bachelor's degree in the Life Sciences
Experience with hierarchical dictionary reporting dictionaries; MedDRA and UMC WHO-Drug.
Thorough understanding of the versioning of MedDRA and UMC WHO-Drug
Complete understand of the construction, versioning and maintenance of MedDRA company Standardized MedDRA Queries (SMQs)
Understanding of medical concepts, biology and chemistry in support of medical encoding
Thorough understanding of regulations, GCP, ICH Guidelines as they apply to coding of medical terminology.
Complete understand of the construction, versioning and maintenance of UMC WHO-Drug company Standardized Drug Groupings (SDGs)
Ideal Candidates Would Also Have:
Experience with encoding computer systems: Oracle Clinical, Thesaurus Management System (TMS), dsNavigator, or Medidata Rave and/or Coder.
About Bristol-Myers Squibb: Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Executive Associate position provides administrative support for multiple directors and teams within Worldwide Publication & Scientific Content organization (WW P&SC). This individual will perform highly diverse administrative duties, which by nature of the position may involve high level contact and exposure to confidential information necessitating the use of tact, diplomacy, discretion and judgment. The candidate must have proven competencies in excellence organization, prioritization, multi-tasking, communication skills, as well as the ability to remain poised and focused in a fast-paced working environment. This Executive Associate can expect high volume in-person and virtual interactions with internal staff or external customers.
Responsibilities (include, but are not limited to):
Provides general administrative support to multiple directors and their teams within WW P&SC organization. Specific activities to support the directors are,
Correspondence management - collect, research, and analyze information; draft letters and documents; proofread and routing correspondence.
Communication management – maintain team and subject focused distribution lists; distribute or cascade messages on behalf of team leaders
Phone and calendar management - schedule and prioritize meetings, resolve meeting conflicts.
Travel & Expense (T&E) management - follows BMS T&E policies, assist on business travel arrangement, visa application and reconciliation of business expenses reports.
Major department/team events/meetings management - plan and execute a variety of different events such as governance meetings, international video conferences, SVP/VP meetings, matrix team meetings, and department off-site meetings; enable and monitor meeting readiness by assembling meeting materials, meeting venue technology testing, distribute pre-read materials and meeting minutes, meeting scribing, etc.
Issue management - liaise issues to proper resolution support teams related to technology equipment, software applications, facilities, etc.; escalates urgent issues to proper management teams or individuals for expedited resolution.
Business operations support -filing system, purchase orders (POs), office supply orders, andotheradministration services. Incumbent will be an expert and point of contact for WW P&SC organization regarding SOW, POs, invoicing, business travel, onboarding, eSetup, etc.
HR related support - partners with People Services to reconcile Workday changes, manage multiple teams’ headcount, and other HR related situations.
General WW P&SC department objectives and project support - collaborates with other Executive Associates within WW Medical Capability to plan and execute special events or projects; assists on ad hoc projects and manage unexpected situations within the WW P&SC organization.
High School degree; Junior Collegedegree desirable.
8 yearsadministrative or comparableexperience;prior BMS or ExecutiveAssistance experience is a plus.
ProficientwithMicrosoftSuite(Outlook, Word, Excel,PowerPoint, Visio). KnowledgeofBMS systems and processes preferred.
Demonstrates ability to prioritize, proactively workindependentlyandcollaboratively with other administrativeassistants/externalpartners across organizationallevels,functions, tosupportbusinessneeds across differenttime-zonesandduringperiodsofheavyworkload.
Ability to multi-task andadapt competing priorities quicklywhileremainingfocused.
Successfulcandidate must be able to learnnew tools and systems in an ever-evolvingenvironment.
Exhibits a positiveworkattitude; a passionate, motivated andhighly flexible individual.
The Contracts Associate is a critical role responsible for negotiation and management of contracts and budgets for clinical trials run across Belgium, Netherlands, UK and Ireland.
Prepares, negotiates and finalises Clinical Trial Agreements (CTAg) with investigator sites across Belgium, Netherlands, UK and Ireland
Negotiates budget and generates financial exhibit/appendix to all CTAgs.
Manages legal exception process for contract negotiations, answers and resolves routine contractual questions independently and promptly escalates legal issues and country specific questions to legal and compliance for advice and tracks resolution.
Manages the financial exception process for contract negotiations by collaborating with financial counterparts and clinical team.
Responsible for driving the internal fund approval process to ensure timely turnaround of contract signature and clear generation of site financial agreement information.
Primary point of contact on indemnity related queries and for consultation on insurance policy requirements.
Primary point of contact for investigator sites to address legal questions and concerns
Interface between the Central Contract and Grant group and hub management to ensure country Site Budget Worksheets are fair, reasonable, adequate, consistent and in-line with local expectations.
Training will be provided but successful candidate must have at least 2 years experience in clinical trials covering the majority of key responsibilities listed above. Excellent communication skills and proficient use of Microsoft Office, especially excel also required.
Product/Brand Reference Point • Have expertise in and knowledge of products, patient treatment trends, Clinical trials and scientific activities within relevant Disease Area(s) and must continuously update this expertise and knowledge •Be the first point of contact for sales force and other functions, if necessaryExternal Expert Manager • Develop and maintain contacts with External Experts based on their expressed needs to further understand and gain both insight and/or input into treatment patterns, including but not limited to: 1 the scientific activities taking place within the relevant Disease Area(s) 2 the needs and treatment trends of healthcare providers • Utilizes therapeutic expertise in contacts with External Experts, to further understand and gain insight into: 1 treatment patterns 2 the scientific activities taking place within the Disease Area(s) 3 the needs and interests of healthcare providers 4 the medical needs of patientsContributor to Customer Focused Activity • Involve in developing scientific presentations (e.g., abstracts or articles based on secondary data) under the guidance of the DAH/DAS/MSM Manager which presentation should be reviewed according to the appropriate internal review processes to ensure medical accuracy and ethical and legal compliance • Propose or conduct scientifically meaningful medical programs such as Continuous Medical Educational Program, Symposia, Round Table Meeting, and Advisory Board Meeting etc. • Identify and prepare speakers for BMS Symposia, under the guidance of DAS, DAH and/or MSM Manager • Provide medical support for promotional activities such as In Hospital Meeting with presentation of scientific information, answering participants' questions within Disease Area or product-related information in a balanced mannerSupport & Trainer • Prepare and/or contribute as appropriate to the initial and ongoing Medical / scientific disease area and product-specific training of internal BMS customers (sales force, etc) – in collaboration with the training department, if any - enabling the sales representative to understand and convey the scientific information of a Brand appropriately in a medical accurate and compliant manner • Liaise with the Medical Information team to provide ongoing scientific and medical support to the business, in particular by responding to queriesContributor to Brand Plans & Strategies • Contribute to the development of Brand Plans and Strategies by communicating his or her medical insight and knowledge derived from healthcare providers or scientific publications about the product or disease area, in particular with reference to patient needs and treatment trends Pharmacovigilance • Work with appropriate BMS personnel to help ensure that all the information regarding SAEs in the field is collected to facilitate a correct and transparent communication of SAEs internally and to the competent Health AuthoritiesClinical Trial/Survey Involvement • Provide feedback to medical data operation (MDO) on Investigator sponsored applications and assist MDO in providing feedback to investigators • Provide input to DASs on trial and survey feasibility and site suitability, based on knowledge of the field •For Investigator sponsored research, refers all questions regarding review status, review process or outcome to the MDO Protocol Manager • May Support BMS sponsored research activities as listed in related DirectivesCommunicator of Medical Information • Presents approved scientific data of varying levels of complexity to Healthcare providers in both group and one-to-one settings • Provides appropriate response and documents the provision of accurate, approved scientific data in response to unsolicited scientific questions or requests posed by healthcare providers for approved Products/Brands and for products in development • Shares medical insights reports in a timely manner with the matrix teams and other internal personnelDaily work recording Record Field Medical daily work in a Customer Relationship Management (CRM) Tool or equivalent system timely and accurately.
Performs administrative duties for department manager. Responsibilities will include but not limited to screening calls; managing calendars; receiving and directing visitors, word processing, making travel arrangement, etc.
Overall department level administrative support, responsibility includes but not limited to department meeting and internal/external event coordination, reports preparation and project coordination, team travel arrangement, systems and email groups update / maintenance.
Data collection, basic analysis and database records maintaining.
1 To facilitate value selling within the allocated budget 2 To develop and plan marketing strategy successfully 3 To implement marketing strategy and tactics optimally 4 To build up and maintain excellent collaboration with other functions
We are seeking a skilled and enthusiastic Research Associate to join our Protein Interactions Group. The candidate will be supporting a variety of biology projects by providing kinetic and epitope information to select and optimize therapeutic antibodies.
- Run high-throughput binning and kinetic screens - Perform detailed analysis of antibody-antigen binding and other protein interactions - Determine active concentrations - Design and analyze experiments under minimal supervision - Present data in written and oral form to project leaders and teams - Collaborate closely with biology, hybridoma and protein engineering groups
- Bachelors and/or Masters degree in Biochemistry, Biophysics, Cell Biology, or similar field - 4+ years of professional experience - Solid math skills, strong attention to detail and excellent bench skills a must - Hands-on experience with biosensor platforms (Biacore, Octet, etc.) as well as cell binding assays (e.g., FACS) highly desirable
- Experience with automation and R scripts desirable - Excellent written and oral communication skills - Excellent time management and organizational skills - Ability to contribute to multidisciplinary discovery teams
The Protein Interactions Group is seeking a skilled and enthusiastic Scientist 1 who loves hands-on bench work to provide quantitative data that drive decisions in a highly collaborative environment. You will represent the Protein Interactions Group at discovery team meetings for a variety of oncology projects, where you contribute with your biophysical expertise to selecting and optimizing therapeutic antibodies.
- Drive the development of new biophysical assays - Improve automation in data collection and analysis, implement new automation features - Characterize antibodies biophysically, notably by determining binding kinetics and epitope bins - Present data and analysis in written and oral form to project leaders and teams - Collaborate closely with Biology, Hybridoma and Protein Engineering groups
- PhD in Biophysics, Biochemistry or related field with 0-5 years of professional experience - Strong understanding of biophysical concepts and solid math skills a must - Expertise in characterizing protein interactions with a variety of techniques - Hands-on experience with biosensor platforms (Biacore, Octet, etc.) as well as cell binding assays (e.g., FACS) highly desirable
- Experience with automation and R scripts desirable - Strong attention to detail and excellent bench skills a must - Excellent written and oral communication skills - Excellent time management and organizational skills - Ability to contribute to multidisciplinary discovery teams