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. 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.

Responsibilities:

The role of Director, Global Clinical Documentation & Submissions will report to the Head of Global Clinical Compliance & Continuous Improvement (GCC&CI) within Global Clinical Operations (GCO), and will be a key member of the GCC&CI Leadership Team.

This role will support GCO through the management of three major processes in the end to end life cycle of Clinical Trials.

Clinical Trial Application (CTA) documentation and submission. This includes tracking of submission requirements ex-US, determination of the appropriate submission strategy with Health Authorities and Ethics Committees, generation of the appropriate documents needed for initial CTAs and subsequent submissions globally including end of trial and distribution of the Clinical Study Reports. Clinical Trial Transparency across the portfolio of clinical trials. This includes providing clinical trial data to patients and the public while ensuring that the applicable legal and regulatory requirements for clinical trial disclosure are met. Informed Consent Form process. An evaluation of the current state and a proposal for improvement and for global oversight will be performed, including the establishment and maintenance of a central Library, and the transition to the future state with eConsent.

This role will lead a team of individuals who have demonstrated core expertise Good Clinical Practice (GCP), ICH and Health Authority rules and regulations. As a matrix leader, the Director of Global Clinical Documentation & Submissions will collaborate with key stakeholders throughout Research and Development including Regulatory, Safety, Quality and other members of GCO to assure document standards are applied consistently across the globe. They will look for opportunities to streamline processes, leverage technology and establish clear metrics for performance.

Externally, this will be an opportunity to help shape the regulatory landscape through engagement with PhRMA, EFPIA, TransCelerate, and other organizations.

Qualifications

• A minimum of a Bachelor's Degree in Life Sciences or equivalent is required. At least 10 years in the pharmaceutical industry and 5 years of experience in clinical trial operations is required.
• Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a diverse and international team
• Customer focus and ability to navigate a matrixed organization and multiple cultural diversities
• Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact. Thorough knowledge of drug development process and clinical operations as well as core understanding of good documentation practices.
• Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks
• Attention to detail with excellent planning, time management and organizational skills
• Excellent communication and presentation skills, high level negotiation skills and the ability to resolve conflict in a constructive manner
• The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.

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.  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.

Key Responsibilities and Major Duties:

• Senior-level clinical operational leader who drives and leads the successful execution of all operational components of a large-scale global clinical program using strong project management, leadership and organizational skills.  Excellent communication skills required.
• Accountable for operational execution across approximately 10-15 clinical trials and addresses and manages risks and issues.
• Contributes to the development of clinical operational strategy and shapes the clinical development plan.
• Represents GCO on the Development Team and serves as the key GCO operational point of contact for the program and respective clinical trials. 
• Drives the development of program level documents and plans and effectively leads a large global team of individuals assigned to the program.

Program Management

• Develops project standards and ensures consistency and efficiency across the program
• Manages a disciplined approach to accurate documentation of the team’s work
• Consistently uses the PMF principles (initiate, plan, execute, control and close) to manage project progress
• Leads and oversees cross-functional teams to ensure successful and efficient execution of studies from start up to final CSR or Regulatory submission
• Integrates lessons learned across the project
• Supports the team in the using the Risk Based Monitoring methodology
• Advises and serves as an expert resource for a broad range of organizational-related issues requiring clinical knowledge
• Acts as point of contact for operational expertise for FDT (Full Development Team)  members and development partners
• Works with GCO functional management and across R+D to secure necessary resources to adequately support the program
•  Achieves results by effective mobilization, development and utilization of resources
• Provides input (as needed) to Health Authority submissions

Operational Leadership/Decision making

• Consistently makes operational decisions in a timely manner
• Uses expert judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities
• Acts decisively to address team challenges
• Contributes to business strategy from an operational perspective
• Leads/co-leads the Clinical Development Team (CDT) and Operations Team meetings; active participant and GCO representative on the FDT
• Facilitates issue escalation and resolution in collaboration with other functional areas
• Actively contributes to issue identification and strategy discussions at senior level meetings

Stakeholder Management

• Addresses the concerns and needs of stakeholders and manages stakeholders’ expectations
• Appropriately seeks input before making a decision
• Facilitates issue resolution and communication/collaboration with stakeholders and other functional area team members
• Builds alliances to gain key stakeholder support, buy-in and ownership
• Builds and nurtures partnerships with internal and external team members that develop and maintain trust
• Partners with business leaders to resolve competing priorities and issues related to stakeholder management

Communication

• Provides vision to build partnerships across functional area leadership
• Consistently demonstrates positive attitude about the team’s ability to deal with challenges
• Drives issues to resolution; communicates to insure that issues have been worked through to completion
• Applies change management principles  to support communication and implementation of integrated change
• Demonstrates diplomacy when interfacing with other functional areas, CROs and other outside vendors.
• Frequently communicates program status to different levels of stakeholders

Development of team members

• Consistently provides accurate, motivating and constructive feedback and coaching to team members
• Invests time in getting to know others to understand their attitudes and views; learns others’ style to interact effectively
• Accommodates cultural differences
• Builds high performance teams to align program and company objectives, assesses training needs and  recommends training where needed
• Partners with functional management to assess skill sets of and set objectives for each team member to enhance developmental opportunities and career development

Minimum requirements

• Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in clinical drug development. 
• Strong leadership competencies and influencing skills with senior leaders and cross functional leaders. 
• Effective oral and written communication skills to influence, inform and guide a large scale global operational team.
• Broad clinical operational experience and strong project management skills.
• Proven team building skills and ability to foster partnerships across projects and multidisciplinary teams.

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.  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.

Responsibilities:

• Partner strategically with the Medical Team (MT) Lead to facilitate the development and execution of Medical Plans for assigned products. Ensure Medical Plan is aligned with TA portfolio objectives/strategies
• Drive transparency of the NRDG/ISR book of work, including decision making across or for individual markets and support operational improvements in that space
• Direct the activities of multi-disciplinary groups to meet the strategic objectives and implementation milestones outlined in the Medical plan(s)
• Maintain Medical plans and manage dependencies across functions and geographies (ie. US) and provide transparency to Medical Directors and senior leaders. Prepare comprehensive project plans and progress reports for team leads, senior management and other stakeholders
• Identify risk areas or barriers that may or are impeding team success and work with teams, Medical leadership, and/or senior management to resolve
• Partner with HQ/US Medical Lead to facilitate MT meetings and ensure the agenda is focused on key deliverables, risk management, issue identification and resolution. Ensure that key actions and agreements are understood and the team is held accountable for their commitments
• Partner with Finance to facilitate the budget process including trade-off discussions and on an ongoing basis ensure the brand budgets (including facilitation of annual budget, monthly projections, accruals, and variance analysis) are on track.
• Identify, develop and implement new processes to facilitate continued evolution of the Operations function and improve efficiency of the Medical organization.
• Build relationships with key stakeholders, including Development, FDT PM’s, Health Economics and Outcomes Research, Commercial and Medical team members, to influence strategic alignment on key Medical objectives.
• Ensure MT members are fully represented in the decision-making process and knowledge exchange is taking place across markets globally.
• Ensure key communication points are captured and disseminated.

Qualifications:

• MBA, MS, PhD, PharmD or other advanced degree or equivalent experience preferred
• Advanced project management skills and relevant experience on matrix management, budget management, metrics and senior leadership communication
• Five or more years of relevant industry experience (Medical Affairs or Development)
• Highly organized and motivated individual possessing strong communication skills and ability to work effectively with cross functional teams
• Experience with drug development and commercialization

Lead Digital Capability Manager responsible for providing technical leadership to plan and execute overall roadmap & portfolio of Veeva related platform & capabilities in Quality domain across the globe. The role will manage and own the delivery of Veeva platform across Quality & Manufacturing across the globe.

Key Responsibilities:

• Responsible for Global delivery of Veeva platform & Programs across Quality & Manufacturing
• Manage and oversee financial budgets of $5-10M+ in portfolio projects
• Responsible for Vendor management, approval of SOWs and invoices in collaboration with Program Manager and IT Business Partners
• Lead and Manage a team of 5-10 indirect reports
• Collaborate with highly matrix team including IT Business partners & Senior Business leaders to contribute, define & own technical strategy & roadmaps for Veeva platform in Quality & Manufacturing area
• Lead a complex matrix team of smart individuals to deliver on large-scale programs
• Responsible for Solution Architecture of Veeva Platform implementation across the globe in Quality & Manufacturing
• Collaborate & contribute to Business case, ensure Architecture reviews & approvals with Enterprise services on all architecture artifacts
• Responsible for building estimations & costs for new programs in the roadmap
• Responsible for building systems which satisfy business needs, appropriately aligned with BMS and industry standards, and are engineered to be reliable, cost effective, scalable, and sustainable throughout the expected lifecycle
• Work with Plan & Build team to plan transition and transition the capabilities built successfully to Operations/Support team
• Work with Enterprise Services team, Architects & support team to implement best practices across the platform

Qualifications:

• BS/BA in Engineering, Computer Science or Life Sciences (or other quantitative related discipline)
• 12+ years overall work experience in Information Technology with 5+ years in Lifesciences and a minimum of 2 years in Quality & Manufacturing domain
• 3+ years’ experience in leading and delivering large-scale global implementations
• To be effective in this role, the incumbent must have technology expertise in Veeva Platform, strong working knowledge of various design patterns and ability to work with matrix team
• The candidate should have a demonstrated track record implementing complex technical solutions, developing software applications following structured SDLC processes in a regulated environment and leading large technical teams
• Experience with industry standard QMS applications like ETQ, TRACKWISE etc would be a plus
• Experience integrating with SaaS and Cloud based applications (e.g., salesforce.com, Amazon Web Services, etc.) would be a plus
• Strong leadership, communication and interpersonal skills; effective manager of people and strong team-building skills
• Strong communication and relationship building skills to establish trust and rapport with the Senior Business leaders
• Proficiency at demonstrating the Core BMS Behaviors

Key Responsibilities:

• Responsible for Global delivery of Veeva platform & Programs across multiple domains
• Responsible for Vendor management in collaboration with Program Manager and IT Business Partners
• Lead and Manage a team of 5-10 indirect reports
• Collaborate with highly matrix team including IT Business partners & Business leaders to contribute, define & own technical strategy & roadmaps for Veeva platform in Regulatory, Medical & Safety area
• Lead a complex matrix team of smart individuals to deliver on large-scale programs
• Responsible for Solution & Integration Architecture of Veeva Platform implementation across the globe
• Collaborate & contribute to Business case, ensure Architecture reviews & approvals with Enterprise services on all architecture artifacts
• Responsible for building estimations & costs for new programs in the roadmap
• Responsible for building systems which satisfy business needs, appropriately aligned with BMS and industry standards, and are engineered to be reliable, cost effective, scalable, and sustainable throughout the expected lifecycle
• Work with Plan & Build team to plan transition and transition the capabilities built successfully to Operations/Support team
• Work with Enterprise Services team, Architects & support team to implement best practices across the platform

Qualifications:

• BS/BA in Engineering, Computer Science or Life Sciences (or other quantitative related discipline)
• 10+ years overall work experience in Information Technology with 3+ years in Lifesciences and a minimum of 2 years in either Regulatory, Medical or Safety domain
• 3+ years’ experience in leading and delivering large-scale global implementations
• To be effective in this role, the incumbent must have technology expertise in Veeva Platform, strong working knowledge of various design patterns and ability to work with matrix team
• The candidate should have a demonstrated track record implementing complex technical solutions, developing software applications following structured SDLC processes in a regulated environment and leading large technical teams
• Experience integrating with SaaS and Cloud based applications (e.g., salesforce.com, Amazon Web Services, etc.) would be a plus
• Strong leadership, communication and interpersonal skills; effective manager of people and strong team-building skills
• Strong communication and relationship building skills
• Proficiency at demonstrating the Core BMS Behaviors

One shared journey moves us forward. Bristol-Myers Squibb is a BioPharma leader offering opportunities to learn and grow professionally, working alongside smart, talented colleagues who are committed to helping patients prevail over serious diseases.

Our medicines help millions of people around the world in their fight against cancer, heart disease, HCV, and rheumatoid arthritis. Our commitment to patients’ unmet medical needs drives innovation and pride in our record of achievement and we are recognized as having one of the most innovative pipelines in the industry with launches in Oncology and Specialty products.

The Scientist/ Engineer is a member of a core team of experts that provide technical expertise and project leadership on location with one of the company’s external manufacturers of Bristol-Myers Squibb biological products. The Scientist/Engineer is knowledgeable and proficient in downstream purification processes for biologics processes.

Duties/Responsibilities:

• Responsible for process fit, technical transfers, process validation, maintenance and continuous improvement of process performance at third party manufacturing and other internal manufacturing facilities.
• Maintain strong working relationship with third party entity.
• Develop and maintain keen technical familiarity with process and process equipment, process optimization, and technical problem solving.
• Prepare, produce, and/or review GMP document, regulatory documents and other technical reports.
• Monitor process parameters and process performance, evaluate any excursion out of history trend.
• Initiate, conduct or lead investigation into any process excursion and quality events.
• Align and maintain collaborative partnership with internal BMS functions such as Process Sciences, Manufacturing Science and Technology, Analytical Development and Testing, QA, QC, and facilities engineering.·
• Independently lead cross functional project team to drive complex process improvement or to enable or enhance organizational capabilities.

Qualifications:

• Direct experience with cGMP protein therapeutic manufacturing.
• Scale-up experience in downstream purification process of biologics.
• High skill level in process development, process scale-up, technical transfers, process troubleshooting, and continuous improvement.
• Working knowledge of regulatory and compliance requirements for biologics.
• Technical writing, computer, and written and verbal communication skills.
• Ability to work effectively as a member of larger cross functional team.
• Travel up to 20% of the time.

Education/Experience/ Licenses/Certifications:

• PhD in protein chemistry, biochemistry, biochemical engineering or other related discipline with 5+ years of relevant experience.
• MS with 10+ years of experience.
• BS with 12+ years of experience

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.

The successful candidate will be part of the Analytical Regulated Testing GMP team at BMS New Brunswick New Jersey within Analytical Strategy & Operations.  The Project Coordinator (PC) provides strategy and oversight to analytical cGMP activities to support clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Products.

Position Responsibilities include but limited to:

• Effective collaboration and communication with  the Integrated Development Team ensuring all  API and drug product release testing, stability testing and filing requirements meet associated clinical timelines
• Management of all analytical cGMP requirements from Phase I through Registrational filing to ensure project deliverable timelines are met.
• Provide technical expertise for evaluation and feedback of methods Provide technical expertise and troubleshooting for technical problems and investigations
• Participate in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.
• Technology transfer of analytical methods to external BMS partners.
• Provides input into audit readiness and expertise for Internal and regulatory inspections.

Qualifications/experience:

• PhD or MS degree in analytical chemistry, organic chemistry, biochemistry or Pharmacy with more than 8 years relevant industrial experience or equivalent.
• Demonstrated knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
• Excellent interpersonal communication skills with capability of interfacing with and influencing multi-disciplinary teams.
• Experience with regulatory submissions and interaction with regulatory agency inspectors.
• Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.

Competencies:

• Demonstrates ability to prioritize project responsibilities to effectively assign and manage resources across the team to meet competing requirements.
• Ability to adapt to change, manage multiple projects effectively meeting timelines.
• Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
• Able to identify opportunities and implement solutions to improve efficiency, productivity and quality/compliance.
• Strong verbal and written communication skills to effectively communicate with key partners both internally and externally.

Responsibilities:

• Directs the daily operation of a biologics QC department testing and reporting of release and stability samples for drug substance and drug product. 
• Defines departmental roles and accountabilities and, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.
• Establishes and communicates performance objectives for QC staff that are consistent with the businesses unit goals, Quality and BDO objectives. 
• Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent.   
• Directs the efficient and timely technology transfer of methods.
• Directs the training and scheduling of scientists in cell and immunological biochemistry, separation sciences, spectroscopy and physical analyses to assure testing activities occur in an efficient and cGMP compliant manner.
• Ensures that all QC personnel have adequate training, education and experience to perform their GMP related job function effectively.
• Directs programs or procedures which assure the proper qualification/calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends and the completion of written investigations in response to unusual or unexpected results or deviations.
• Participates in compliance related teams working towards the goal of continuous improvement. 
• Participates in the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
• Ensures all necessary testing is carried out.
• Issues and prepares or approves laboratory investigations using electronic investigation management system (e.g. TrackWise), as needed.
• Administers and maintains Laboratory Information Management System (LIMS), stability and retention programs.
• Ensures that stability data supports the retest / expiry date and storage conditions of the product.
• Ensures that stability studies performed at the site are performed according to approved protocols and procedures.
• Ensures an effective process is in place for reserve sample collection and storage.
• Completes Annual Product Quality Review Report elements as established in products/systems schedule.
• Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.

Qualifications:

• Knowledge of science generally attained through studies resulting in a Master of Science degree in science, engineering, biochemistry, related discipline, or its equivalent is required
• A minimum of 10 years experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility of a biologics Quality Control laboratory or a related biopharmaceutical industry.
• In depth knowledge of analytical biochemistry quality control procedures, and the application and interpretation of GMP concepts and compendia requirements e.g. USP, CFR of daily laboratory operations. 
• Knowledge of laboratory equipment, instrumentation, and techniques including, but not limited to, HPLC, LCMS, spectroscopy, cell culture and immune assays.
• Experience in building and growing an organization into a high performance team is highly desirable.
• Experience leading and managing a large, multi-leveled organization is essential.
• Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance is required.
• Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Knowledge of applicable business systems including: SAP, LIMS, Maximo and Trackwise.
• Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as DeltaV is desirable

Associate Directors have business needs to interact with any employee at any level of the Devens facility with daily interactions with other Quality Unit staff, Supply Chain, IT/Automation, Technical Services and Manufacturing staff.  Additional contact with general business functions includes human resources, EHS, Finance and interaction with BMS staff at other locations including corporate.  In addition there is periodic contact with outside vendors as well as the occasional direct interaction with representatives from health authorities / regulatory agencies.

Work is largely performed in a modern office, laboratory and manufacturing facility where one must be aware of the presence of workplace hazards including pressurized liquids gases, steam and hazardous chemicals.  Use of Personal Protective Equipment (PPE) will be required in some portions of the facility.

Establishes operational objectives and delegates assignments to subordinates.  Objectives are reviewed by senior management to determine success of the operation.  The incumbent is involved in developing, modifying, and executing company policies that affect immediate operations and may have company-wide effect.  Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.  Ensures budget, schedules and performance requirements are met.  Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

Works with minimal supervision on the accomplishment of agreed upon goals and objectives.  Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.

Titre : Gestionnaire, Analyse et planification financières – Médicaments novateurs

Lieu de travail : Montréal

Responsabilités :

• Préparer et analyser le budget annuel, le plan stratégique et les prévisions financières en collaboration avec l’équipe commerciale, Analyse et planification financières, les collègues en comptabilité et le chef des Finances.
• Effectuer une analyse coûts et avantages, faire des rapprochements profits et pertes et prendre des mesures correctives pour assurer que les objectifs de croissance et de productivité sont pris en compte avec exactitude et font l’objet d’un rapport (entière responsabilité de l’analyse liée à Orencia).
• Établir des prévisions mensuelles pour les niveaux de rentabilité et de dépenses. Assumer la responsabilité de tous les aspects du budget lié au coût des biens, et de l’analyse des écarts, y compris les coûts de gestion, les redevances, les biens gratuits, la taxe d’accise, la réévaluation et le suivi de l’obsolescence et les rapports connexes.
• Établir les prévisions et faire l’analyse des ventes d’Orencia. Créer des liens avec l’équipe de la marque et l’équipe Perspectives et analyse des activités commerciales afin de coordonner et de modéliser les tendances des ventes et les hypothèses en matière de ressources.
• De concert avec l’équipe de la marque, présenter à la haute direction les changements, les recommandations de même que les risques et les possibilités liés à la marque.
• Exprimer son point de vue financier de façon précise, opportune et de manière à susciter la réflexion dans toutes ses interactions avec les équipes de la marque et la haute direction.
• Assurer la liaison avec le groupe Accès aux marchés afin de veiller à ce que toutes les hypothèses pertinentes au chapitre de l’accès soient prises en compte avec exactitude dans les prévisions des ventes.
• Participer aux activités de l’équipe de la marque et se tenir au courant des enjeux commerciaux et des possibilités d’affaires.
• Coordonner les dépenses directes liées à un produit avec les principaux intervenants. Effectuer un suivi et une analyse des dépenses en temps opportun afin de veiller à ce que les équipes soient bien informées de l’état de leur budget et soient en mesure d’exécuter leurs activités conformément aux plans transmis à la haute direction.
• Posséder les connaissances techniques requises pour appliquer les règles de comptabilité et pour déterminer les incidences sur les activités commerciales (c.-à-d. comptabilisation des revenus, incidences fiscales et comptabilité de l’alliance).
• Assurer une sensibilisation et une conformité accrues aux politiques, aux procédures et aux contrôles dans toute l’organisation.
• Réaliser divers projets ponctuels et diverses initiatives ayant trait à l’amélioration du processus, à des initiatives de simplification; aux exigences réglementaires et gouvernementales et aux besoins des administrations centrales locales ou régionales.
• Être en mesure d’assurer une communication efficace avec tous les paliers de gestion, tant à l’échelon local qu’à l’échelon régional est une approche essentielle à la réussite.
• Toutes les tâches doivent être exécutées de manière proactive et professionnelle.

Exigences :

• Dix (10) années d’expérience pertinente dans le domaine des finances.
• Excellentes aptitudes analytiques combinées à un sens aigu des affaires et une expérience solide dans le domaine.
• Connaissances en comptabilité; connaissance approfondie des logiciels comme Excel, PowerPoint, etc. Compréhension de la fonctionnalité SAP relative aux actifs.
• Excellente capacité en résolution de problèmes, en relations interpersonnelles et en facilitation.
• Capacité à travailler sans supervision, à s’adapter à des priorités changeant rapidement et à exécuter des projets en respectant des délais serrés.

Études :

• Maîtrise en administration des affaires (MBA), ou accréditation professionnelle en comptabilité ou spécialiste des finances (une exigence).

RESPONSIBILITIES:    

•    Preparation and analysis of the annual budget, strategic plan and financial projections in association with commercial team, FP&A and accounting colleagues and Head of Finance.
•    Cost/benefit analysis, profit and loss reconciliations and corrective measures to ensure growth & productivity objectives are accurately accounted for and reported (with full ownership for Orencia analysis).
•    Forecasting monthly profitability and expense levels.  Responsible for all aspects of Cost of Goods budgeting and variance analysis including management cost, royalties, free goods, excise tax, reval and obsolescence tracking and reporting.
•    Forecasting and analyzing Orencia sales.  Liaise with brand team and BI&A to coordinate and model sales trends and resource assumptions.
•    In conjunction with the brand team, present senior management with changes, recommendations and risk & opportunities related to the brand.
•    Articulate finance point of view in an accurate, timely and thought provoking manner in all dealings with brand teams and senior management.
•    Liaise with Market Access to ensure any relevant access assumptions are accurately accounted for in the sales forecast.
•    Participate in brand team activities to keep abreast of business issues and opportunities.
•    Coordinate direct product expense with key stakeholders.  Provide timely tracking and expense analysis to ensure teams are well informed of the status of their budget and are able to execute according to the plans communicated to senior management.
•    Technical knowledge required to apply accounting rules and determine implications for the business (e.g. revenue recognition, tax implications, alliance accounting).
•    Increases awareness and compliance of policies, procedures and controls throughout the organization.
•    Complete various ad hoc projects and initiatives dealing with process improvements, simplification initiatives; government & regulatory requirements, and local or regional head office needs.
•    Effective communication with all levels of management, both local and regional is critical to the success of this position.
•    All duties must be executed in a proactive and professional manner.

Job requirements:

• Ten (10) years of relevant experience in finance.
• Excellent analytical skills, combined with solid business experience/acumen.
• Knowledge in Accounting; Strong knowledge of software usages such as Excel, PowerPoint etc. Familiarity with SAP an asset.
• Excellent problem solving, interpersonal and facilitation skills.
• Ability to self-manage, adjust to rapidly shifting priorities and deliver projects with tight deadlines.

Education:

• MBA or Professional accounting/finance designation required.

Description de la société

Bristol-Myers Squibb est une entreprise biopharmaceutique globale dont la mission est de découvrir, développer et mettre à disposition des médicaments innovants pour aider les patients à combattre des maladies graves.  Le modèle « BioPharma » qui combine les forces d’une grande firme pharmaceutique avec les atouts et l’agilité d’une société de biotechnologie, est aujourd’hui devenu une référence pour l’industrie.

Avec près de quarante molécules en développement dont trois en phase finale, Bristol-Myers Squibb dispose aujourd'hui de l'un des portefeuilles les plus prometteurs de l'industrie pharmaceutique.

• 25 000 collaborateurs
• Chiffre d'affaires 2014 : 15,9 milliards de dollars

Bristol-Myers Squibb France, 1ère filiale du groupe hors Etats-Unis en termes de R&D et deuxième en termes de chiffre d’affaires, compte 2400 collaborateurs (14ème laboratoire en France). Le siège social de l’entreprise est situé à Rueil-Malmaison, en banlieue parisienne.

Entreprise consciente de ses responsabilités sociétales, Bristol-Myers Squibb déploie en France, un vaste programme d'actions environnementales. L’intégrité, l’éthique et le respect de la diversité culturelle, font partie des principes fondamentaux de Bristol-Myers Squibb. Pour nous, le pluralisme au sein d'une entreprise, est un des facteurs de sa performance, sa compétitivité et sa créativité.

Description du poste :

• Activités principales
• Management hiérarchique d’une équipe de 12/15 Moniteurs Régionaux, basés en région ou à Rueil-Malmaison
  
  En collaboration avec le Sr Manager Moniteurs Régionaux :

• Définir les besoins en ressources humaines pour les projets de développement clinique en Oncologie et Immunosciences et animer et coordonner les équipes réalisant le monitoring dans le respect de la règlementation et des délais
• Interactions avec équipes globales et coordination avec les autres équipes du Hub
• Management de l'équipe des Moniteurs Régionaux
• Allocation et réallocation des ressources humaines interne ou externe
• Contrôle de l'application des procédures et de la réglementation en matière de
  monitoring
• Validation des compétences techniques des moniteurs
• Planification et suivi des activités des moniteurs
• Accompagnement des moniteurs sur le terrain (développement des compétences) et tutorat
• Collaboration quotidienne avec le Sr Manager Moniteurs Régionaux en assurant la transparence, la coordination et la complémentarité des 2 équipes de monitoring
   
• Compétences
• Anglais courant parlé et écrit impératif (toutes activités et documents/outils en anglais + correspondance et téléconférences avec équipes globales)
  • Esprit d'équipe, flexibilité, leadership, orientation résultats, gestion de priorités, ouverture au changement

• Formation & Expérience
• Formation scientifique > 5 ans
• Expérience de monitoring ou coordination clinique internationale > 5 ans
• Expérience de management hiérarchique
• Formation GCP/ICH + formation recherche clinique