Aufgabengebiet:

Als Mitarbeiter im rheumatologischen Außendienst (m/w) im Gebiet (Heidelberg, Mannheim, Karlsruhe, Stuttgart, Heilbronn) sind Sie verantwortlich für den Verkauf von unserem Produkt ORENCIA. Wir suchen Kolleginnen und Kollegen, die Ihrem Job mit Leidenschaft und hoher Motivation nachgehen

Sie beherrschen moderne Verkaufstechniken und betreuen und beraten niedergelassene Fachärzte und Fachärzte in Kliniken. Sie konzipieren selbstständig Vertriebspläne und innovative Veranstaltungskonzepte für Ihr Gebiet und setzen diese zuverlässig um. Sie beobachten und analysieren den Markt und reagieren umgehend durch die Anpassung Ihres Gebietsvertriebsplanes. Sie sind geübt im Umgang mit modernen Analysemethoden des Außendienstes und entwickeln sich gerne weiter. Zudem sind Sie für die Organisation, Einladung und Durchführung von Fortbildungsveranstaltungen in Ihrem Gebiet verantwortlich. Auch übernehmen Sie Standdienst und Kundenbetreuungen auf nationalen und internationalen Fortbildungsveranstaltungen und Kongressen.

Anforderungsprofil:

Sie sind Pharmaberater/in gemäß § 75 AMG und haben ein naturwissenschaftliches Studium abgeschlossen oder Sie sind Geprüfte/r Pharmareferent/in; ein betriebswirtschaftliches Studium ist von Vorteil. Zudem verfügen Sie idealerweise über gute Englischkenntnisse, sehr gute PC-Kenntnisse runden Ihr Profil ab. Sie nutzen Ihr kommunikatives Talent, denken konstruktiv und strategisch, um neue Kundenkontakte aufzubauen und bestehende Geschäftsbeziehungen zu vertiefen. Mit Ihrer gut organisierten, eigenverantwortlichen und teamorientierten Arbeitsweise überzeugen Sie Ihre Geschäftspartner und tragen damit zur Erreichung der gemeinsamen Ziele innerhalb der Region bei. Der Umgang mit modernen Kommunikationstechnologien ist für Sie selbstverständlich. Räumliche Mobilität und Flexibilität sowie das Potenzial und die Bereitschaft zur Übernahme zukünftiger Führungsaufgaben im Marketing und/oder Vertrieb komplettieren idealerweise Ihr Profil.

Meetings Management Specialist (D04)

POSITION PURPOSE

Pharmaceutical Meetings Management is one of the fastest growing capabilities. The Specialist role in the Events & Meetings team proactively ensures that the needs of the business are met through strong, engaged collaboration with our Healthcare Professionals (HCPs), Commercial, R&D and Medical colleagues.  They are an expert on the end to end Health Care professional transactions and meetings management process.  Close alignment to the Commercial Business within the local market is crucial in addition to supporting training and resources specific to Meetings Management across the multi-disciplinary team.  The Specialist will be expected to support the implementation of key projects associated with the Events and Meetings Management Centre of Expertise (EMCoE) team and lead on smaller scale projects where appropriate.  The role will provide multiple opportunities for process simplification, innovation and personal development.

Efficient meetings management and speed with HCP payments by the EMCoE team will enable incremental business performance through empowerment of the team to simplify  processes, technologies and develop local innovative solutions that will enhance the overall customer experience (both internal and external) at BMS meetings and events.  By demonstrating a strong value proposition to the Commercial business EMCoE will be able to deliver sustained long term operational cost savings without compromising efficiency. 

MAJOR DUTIES AND RESPONSIBILITIES

• Acts as an expert facilitator of Meetings & Events with respect to Health Care professionals, venue contracting and coordination of invitations, travel logistics, material preparation and  budget management from event initiation through execution and close out.
• Accountable for own actions contributing to the execution of all events, in accordance with BMS Standard Operating procedures (SOPs) as well as statutory compliance requirements for the local market.  Conducts due diligence across all activities
• Develops and maintains strong relationships across the matrix environment, building alignment and strong communication with multiple internal and external stakeholders
• Collaborates with other experts including the Meetings Management Business Partner, Strategy and Ops,  Legal & Compliance, Global Expenditures, , Global HCP, Congress & Meetings Management, and Business control, seeking advice where appropriate
• Proactively seeks opportunities for process simplification, seeks input and engages the support from multiple stakeholders
• An expert facilitator on contract management, advising stakeholders on the HCP contracting process within the local market and simple cross border activities.
• Supports driving the strategy for continuous improvement with standardization, automation and process simplification.
• Responsible for ensuring speed with escalation and resolution of issues relating to meetings management and HCP payments
• Supports the meetings Management Business Partner with implementation of training in both the local market and cross border, supports the development of training materials and maintenance of local market SharePoint site.

KNOWLEDGE, SKILLS, and COMPETENCIES:

Education/Experience

• Insight and experience of having worked in a sales/marketing environment  or experience in a commercial customer facing role with a minimum of 1-2 years’ experience
• Business or technical undergraduate degree or recognised professional qualification
• Experience of leading and managing small to medium scale projects with complexity
• Experience in Contracting,  HCP Payments, Event Management in the HCP transactions area
• Has a comprehensive understanding of internal compliance processes and external statutory code requirements across the local market, including transfer of value reporting in relation to HCP meetings and transactions and HCP tiering/payment rates
• Understanding of corporate infrastructure and deployment methodologies in order to drive continuous improvement
• Fluency in English

Functional / Technical

• Demonstrated team orientated approach with examples of local leadership
• Demonstrated ability to work independently and effectively in an internal and external matrix environment, with strong interpersonal and influencing skills
• Strong written and verbal communication to facilitate relationships with peers and management
• Demonstrated ability to assess, escalate where appropriate and promptly resolve problems
• Demonstrated ability to apply strong quantitative and analytical skills to provide business solutions with a customer-centric focus
• Demonstrated ability to effectively manage own workload in line with business needs
• Proven ability to demonstrate an innovation mind-set, including simplification of processes
• Demonstrated high level of proficiency in using IT and online systems for managing processes and reporting purposes

DEVELOPMENTAL VALUE

• Opportunity to directly impact customer experience
• Development of effective collaboration skills working across the matrix with a wide range of business partners
• Opportunity to develop Local leadership across own market
• Provide support for training and project implementation across own and other markets
• Develop the ability to effectively communicate, negotiate challenging situations and positively influence change
• Develop an expert understanding of the changing healthcare environment and the customers within it
• Opportunity to take ownership for specific processes and small to medium scale projects with involvement in complex activities
• Opportunity to work within a global or regional team, with technically and culturally diverse people

Summary:

The Regulatory Affairs area is strategic for the growth of the company. Through regulatory processes with ANVISA, the company expands and renews its portfolio. The regulatory environment is constantly changing, requiring companies to be ready to anticipate them, analyze their impacts, plan and implement them in a timely and effective manner. In addition, the Regulatory Affairs area is also responsible for ensuring that the company complies with the applicable health regulations in order to continue business, avoid penalties and protect the company's image. The Regulatory Affairs Analyst should be prepared to work in this environment and deliver the expected results through teamwork, timely and quality. 

The position is in full compliance with BMS laws, regulations, policies and procedures, including business rules, as well as BMS Conduct and Ethics

Primary objectives include, but are not limited to: 

• Understands and fulfills current and local regulations and internal policies, as well as the extent of impact of evolving changes, while assessing, planning and executing regulatory processes.
• Prepares any type of regulatory filings (registration, post-approval variation and DDCM for biological and synthetic drugs; GMP certificates and sanitary licenses submission and renewal) without supervision.
• Understands and formulates options for regular or exceptional issues, being able to propose mitigation / contingency plans and drive execution.  He/she does not make decision on this matter.
• Prepares and updates local labeling components, reviews and approves promotional materials in full adherence to the BMS policies and local applicable regulations. 
• Timely and accurately feeds systems, databases and archives.
• Drives contacts and consultations with the HA within his/her area of responsibility, including technical – operational HA interactions
• Participates in external forums as might be required and represents the company upon designation
• Develops its own working plan taking full accountability for resource allocation, timely and quality results within his/her function, adequately

CONNECTIVITY

• Connects and collaborates across the local, regional and global  functions as required
• Builds personal credibility and strong working relationships
• Focus on patient and customer needs to drive results
• Learns and shares best practices across the function
• Demonstrates commitment to timely deliver quality results

Education:
Bachelor degree in Pharmacy.

Experience:
• Experience in the regulatory area for at least 5 years in the various types of regulatory processes: preparation of new product registration, post registration, renewal, maintenance of records and administrative documents (GMP certificate, Licenses, etc.) and routine regulatory activities.
• Previous experience with biological drugs is mandatory.
• Previous knowledge about DDCM is desirable

Skills, Competencies and Knowledge
• Ability to develop new projects, contingency plans and solution / mitigation of regulatory problems
• Knowledge of the regulations applicable to new and biological drugs
• Knowledge of Clinical Research regulations will be considered a differential
• Ability to interact in all functions and geographies
• Teamwork, interpersonal relationships, commitment and dynamism
• Ability to communicate fluently (written and verbally) in English and Portuguese
• Ability to organize / prioritize tasks

CONNECTIVITY

• Connects and collaborates across the local, regional and global  functions as required
• Builds personal credibility and strong working relationships
• Focus on patient and customer needs to drive results
• Learns and shares best practices across the function
• Demonstrates commitment to timely deliver quality results

Develop strategies focused on private health care providers’s market in order to minimize the hurdles to market access, provide knowledge and work along with private managers and auditors, with the objective of fostering patients' access to BMS drugs, breaking down barriers, optimizing the patients’ journey, following all the rules and guidelines of Ethics and Compliance.

Wallingford Transition

ASSOCIATE DIRECTOR-EPIDEMIOLOGY

Job Summary:
• Directly supervises the work in one therapeutic areas (TA),
• Prioritizes activities across multiple projects in the assigned TA and effectively negotiates plans with colleagues and customers.
• Communicates the role of pharmacoepidemiology within GPV&E and throughout BMS.
• Ensures TA epidemiologists apply theoretical principles to real problems and bridge uncertainty of the real world with innovative pharmacoepidemiologic solutions.
• Ensures TA team epidemiologists evaluate risk-benefit of pharmaceuticals in context of worldwide regulatory agency use of epidemiologic data.
• Advises on pharmacoepidemiology principles to others in R&D.
• Ensures that all tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness; and in accordance with current global regulatory requirements, good pharmacoepidemiology guidelines, and BMS cost effectiveness goals.

Qualifications:
• PhD in epidemiology or (MD, DO), MPH, at least 3-5 years’ experience in the pharmaceutical industry, some management experience preferred

Strong senior contributor who also leads a team of individual contributors to drive strategic and tactical delivery of Biomarker activity at the asset level while ensuring rational alignment of asset strategy and protocol execution, including:

• Responsible for the design and evolution of the functional processes for, and drives individual development of, Program Level Biomarker Sample strategy documents (Laboratory Test Plan and Sample Risk Matrix) for a complex collection of assets under his/her accountability in close collaboration with one or more Biomarker Lead.
  • Multi-functional team engagement and leadership
  • Seeks opportunities to enhance value of external vendor relationships through early strategic engagement and ongoing partnership
  • Drives the IT environment that delivers strategic documentation and supports the analysis of study designs vs. strategic plans.
• Team Leader who develops his/her staff in the application of a disciplined project approach to develop and execute operational plans to ensure delivery of Biomarker data to meet the requirements of the Program and the studies executing within them; documenting and managing associated issues and risks; setting agendas for operational program reviews and documenting outcomes, decisions and key learnings
• Responsible to evolve IT capabilities to enhance operational effectiveness in the initiation and oversight for request management of Biomarker assay development or sample analysis; ensures all work is documented in alignment with the protocol and the program strategy
• Independently or in partnership with one or more Biomarker Lead identifies and activates samples for analysis
• Collaborates with Execution Analysts to ensure effective sample movement through analysis and to final storage; partners with Biomarker Execution leadership to identify opportunities for increased leverage of internal and third party capabilities to drive sample execution
• Drives integration with clinical operations organization and data management to execute and streamline the processing for cleaning sample metadata as needed to ensure integrity of specimens and downstream analysis

• Experienced program manager counsels staff in the execution and maintenance of a clear Book of Work/Program Plan to facilitate cohesive and uniform transparency across many projects and external partners; also, responsible for his/her own complex, highly visible, book of work

• Process owner for those processes and tools necessary to manage and triage critical, “systemic”, issues for the Biomarker Operations function; ensures his/her staff maintains the discipline to document issues from identification through resolution.  For his/her complex program of assets, maintains highest standard of program discipline and ensures learning is shared across the organization 
• Demonstrates strong communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution
• Serves as TMES liaison to lead or support other strategic and process improvement initiatives affecting his/her platform area(s) as required

Qualifications:

• B.S., M.S. in a scientific discipline; 8+ yrs direct line management experience; with experience in Biomarker Operations or Clinical Study execution desired.
• 4+ years of complex relationship management expertise e.g. vendor management, lab operations management
• Demonstrated knowledge of legal/regulatory environment governing sample management and informed consent; experience applying consistent interpretation for self and others as needed to drive compliant specimen use
• Demonstrated ability to establish a team mission/vision, define key metrics needed to measure organizational effectiveness, develop staff and grow a diverse team of individual contributors
• Balances team leader responsibilities and his/her own, complex, workload; strong voice to empower leadership and remove barriers for self and others.
• Sustains and demonstrates experience growing a diverse network within BMS and outside of BMS; leverages broad relationships to enhance personal and organizational outputs
• Experience establishing effective priorities for self and staff, while working with a sense of urgency, delivering on multiple projects and challenging, and often volatile, deadlines
• Experience designing effect business process flows and developing measures of process efficiency
• Skilled listener with ability to manage complex internal and external relationships through constructive conflict management; experience with third party governance oversight desirable
• Strong attention to detail and ability to work with high volumes of data independently and in collaboration with a multi-disciplinary scientific team; demonstrates mastery of and experience in coaching technical skills such as Excel and/or Spotfire
• Experienced in developing and implementing agile, creative solutions, utilizing direct and indirect resources, to solve business challenges within the line organization, across the company, and in partnership with external collaborators
• Highly collaborative, team leader and team-player who regularly seeks perspectives both within and outside of his/her direct accountability to develop and implement high value solutions

Accountable for all marketing activities related to I-O brands, ensuring budget delivery. Management of team of Tumor Leads. Direct interface with Medical I-O DAT

Operatore di Produzione: Effettua le operazioni previste nelle varie fasi della produzione farmaceutica (manualmente o con l'ausilio di macchinari). Svolge attività di cambio formato, cambio prodotto, gestione materiali e caricamento della linea, gestione scarti e difettosità. Compila la documentazione prevista riportando i risultati ottenuti durante i controlli di processo, in allineamento con gli standard e le procedure GMP.

Operatore di Magazzino: Effettua la ricezione, lo stoccaggio, la spedizione di merci, utilizzando il muletto o sistemi automatizzati, provvedendo anche all'imputazione dei dati su terminale; prepara i documenti di trasporto in caso di spedizioni; consegna la merce alla produzione sulla base di appositi ordini di consegna; collabora alla verifica dell'esistenza della merce in magazzino in occasione dell'inventario. Il tutto nel rispetto delle normative e delle procedure aziendali vigenti.

Operatore di Manutenzione: Effettua gli interventi e le regolazioni elettriche, meccaniche e strumentali. Le attività comprendono il sopralluogo presso la macchina o l'impianto, la diagnosi del malfunzionamento, la sostituzione dei pezzi, il collaudo finale. In manutenzione ordinaria, effettua la verifica del regolare funzionamento, lubrifica, sostituisce le parti usurate. Per lo svolgimento della sua attivita' utilizza attrezzature manuali e strumentazioni specifiche, agendo nel rispetto delle procedure aziendali.

Sono requisiti indispensabili:

• diplomi: preferibilmente perito tecnico, chimico, chimico biologico, industriale, commerciale, ragioneria; liceo: classico e scientifico
• motivazione a riscoprire un ruolo operativo, a tempo deterrminato, eventualmente con contratto di somministrazione lavoro;
• esperienza in produzione farmaceutica o, in subordine, esperienza  in produzione generica (es. aziende meccaniche, alimentari, elettroniche);
• flessibilita'/disponibilita' a lavorare su turni a ciclo continuo e discontinuo;
• capacita' di lavorare in team;
• estrema attenzione alle procedure di Qualita' e Sicurezza.

Rappresentano, inoltre, requisiti preferenziali:

• esperienza pregressa (anche se breve) nelle mansioni proposte e/o nel settore farmaceutico in generale;
• essere automuniti

Per il reparto Controllo Qualità Chimico dello Stabilimento di Anagni, ricerchiamo un Analista di laboratorio che si occupi di effettuare analisi fisiche e chimiche su campioni di materie prime, prodotti finiti e semilavorati e di eseguire campionamenti in produzione.

Nello svolgimento delle varie attività l’Analista Controllo Qualità Chimico è tenuto al rispetto dei tempi, metodi e standard di qualità, della normativa vigente e delle procedure aziendali.

Requisiti:

• Diploma perito chimico e o industriale e/o laurea in Chimica o Chimica e Tecnologie Farmaceutiche
• Preferibile esperienza pregressa nelle mansioni descritte in aziende farmaceutiche o in laboratori.
• Buona conoscenza lingua inglese
• La risorsa deve essere in grado di utilizzare un’ampia gamma di apparecchiature di analisi come l’HPLC, IGC, spettrofotometria e gascromatografo.

Il candidato ideale è preciso, metodico, affidabile, motivato ed orientato al risultato; è dotato di estrema attenzione alle procedure di qualità e sicurezza, problem solving, ottime capacità di relazione e propensione al lavoro di squadra.

Independently monitors the progress of assigned Investigator sites by maintaining close contact with site

personnel and Site Monitors. Coordinates and maintains effective communication (oral, written), and serves as

a BMS contact for the Investigator. Provides feedback and status updates to internal stakeholders on an

ongoing basis. Demonstrates an understanding of the overall project goals, the indication studied and the

purpose of the assigned study in meeting the objectives of the project. Works closely with other study team

members in the coordination of study activities to meet the appropriate timelines at the site / protocol level.

•

Independently manages activities at the site by providing guidance as required and by collaborating with other

key stakeholders (e.g. Medical Monitor, Protocol Manager, Site Manager(s)). Documents substantive contacts

concisely and in accordance with SOPs. Identifies potential issues and suggests resolutions. Answers and

resolves routine or site related questions independently. Knows when to defer difficult or unresolved issues to

the appropriate team member

•

Coordinates data management activities (e.g., reviewing edits, data listings and tables, sending queries to

Investigator sites, etc.) and updates the clinical data base. Collaborates closely with other study team members

(e.g., Site Manager(s), Protocol Manager) to monitor study progress and resolve issues at the site or protocol

level.

•

Independently disseminates information to appropriate BMS team members to ensure timelines are met (e.g.,

Site Manager(s), Site Monitors, Clinical Trial Associate). Identifies and resolves issues noted during site and

data management of the overall protocol timelines and informs the appropriate BMS team members (e.g.

Protocol Manager, Data Specialist) and coordinates follow-up.

•

Ensures program level standards are applied at the protocol level from study start-up to data base lock. Shares

experiences and best practices through coaching and feedback.

•

Skilled in the use of technology. Is able to function independently in addition to coaching other team members

within an environment that relies heavily on this knowledge for information and communication. Effectively uses

available tools (e.g., IMPACT, IReview, SMTs, eDM) to gather information needed to manage site activities,

generate reports and to provide feedback to Site Manager(s), Protocol Manager and Medical Monitor.

•

Communicates information and issues (globally or on a country level) to Site Monitors, Site Managers, and

Protocol Manager to ensure that site management activities, protocol execution and study documentation are in

compliance with study timelines, ICH-GCP guidelines, BMS SOPs and local regulatory guidelines or

regulations.

•

Demonstrates a thorough understanding of all steps in the clinical research process. Coordinates initial and

ongoing training of Investigators, site personnel, vendors etc, and collaborates with Study Strategy and

Planning when appropriate.

•

Provides on-going training and mentoring to team members through a mentoring process using informal and/or

formal presentations. Serves as a resource for colleagues. Understands how the issues of a single study can

impact the overall project and contributes to establishment of best practices through coaching and feedback.

•

• Leads or participates as an active member of cross functional teams or task forces.