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At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities

• Supports delivery of clinical supplies through effective management of assigned projects.  Manages multiple projects.  Liaise with responsible Trial Supply Manager on aspects of clinical supplies packaging and labelling design and study requirements.  Ensures production schedules meet agreed upon on-time delivery date of finished supplies.  Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects.  Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text).
• Generates internal packaging and labelling production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects.  Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including relevant checks on order accuracy.
• Executes all required SAP transactions such as goods receipt and goods consumption.  Assures Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS).  Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required.  Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use.   Liaises with Quality Assurance to secure release of finished supplies.
• Supports externally managed projects via outsourcing project management; generates and approves project specifications for label print and production.   Manages external manufacturing transactions in SAP and sample execution.  Manages and tracks all activities and milestones related to outsourced work and other departmental projects as assigned.   Ensures pricing and terms in label vendor quotation is consistent with MSA.  Circulates purchase justification memos and issues purchase orders in accordance with company policy. 
• Reviews and approves vendor generated label overprinting proofs and other related documents.  Reviews and approves vendor generated production orders and other related documents (i.e. change orders).
• Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit.  May enter change controls and deviations into quality management system and conduct investigations as assigned.
• Works cross-functionally with individuals and project teams in various areas.
• Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.
• Participates in assigned training including CGMP and safety training.
• Authors and reviews procedural documents.

Competencies Required

• Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
• Strong project management skills.
• Possesses solid oral and written communication skills.
• Good decision making and organizational skills.
• Demonstrates ability to effectively communicate ideas and to influence others to achieve results.
• Knowledge of and ability to understand and apply regulatory and CGMP principles.
• Knowledge of ERP/MRP systems and supply chain principles.
• Eager to learn and continuously improve.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Purpose:

This position is responsible for the complex activities related to Record to Report including (but not limited to) journal entry processing, closing activities, reconciliations, and other complex financial processes and also for the Continuous Improvement in R2R.

Main Job Responsibilities

• Positions require extensive remote interaction with Business Unit Finance Personnel, Finance Shared Services, Accenture Partners, Corporate Financial Reporting and Global Process Owner Team.
• Perform tasks accurately and independently as assigned by line manager through application of accounting and business knowledge (for example open purchase order review and analysis of related accruals, preparation of working files and related journal entries including GTN, Obsolescence provision and other inventory adjustments, Lease accounting).
• Prepare and review scheduled Balance Sheet Account Reconciliation Activities, action, monitor and execute escalations. Exhibit mastery of relevant Standard Operating Procedure and the reconciliation tool. Perform scheduled risk assessment in collaboration with the market, CFR, BCF and global process owners.
• Independently prepare and present balance sheet reviews.
• Monitor and manage specific month end (and year-end) related activities per Month End Close Timetable in collaboration with local market and 3rd party service provider. Understand overall closing schedule and assignment of tasks during the close and their respective deadlines and dependencies.
• Participate in daily monitoring calls during month end close. Escalate potential risks in delays to month end tasks to Satellite support/GPO via daily monitoring calls.
• Coordinate above market processes related to audit, for example, monitoring auditor system accesses, completion of PBC tasks as assigned, close partnering with centralised audit team. Independently resolving complex queries and requests.  Support on audit planning process e.g. agree scheduling of key milestones.
• Independently execute complex activities required by individual market external authorities (eg tax administration, industry representation etc.).
• Continuous improvement in R2R, co-ordinate the optimisation of processes across the markets or companies within the market, consistently implementing best practices.
• Have a good working knowledge of company systems, procedures, policies and controls, information sources and analytical techniques. Actively execute update of work instructions per defined scope and schedule and as required for routine process changes. Discuss potential impact of changes in company accounting policies communicated in Technical Accounting Meetings with line manager.
• Assist country controller in execution or execute independently legal entity budgets and projections including profitability review and transfer pricing documentation.
• Conduct complete ad hoc projects and unusual or complex assignments initiated by GPO or operations, supporting multiple projects in a time sensitive environment, with only general review from manager/project lead.

• Actively obtain understanding of local business through interaction with market contacts and GFS lead and apply this to assigned tasks. Become subject matter experts in relation to processes performed.
• Co-operate and develop strong relationships with internal and external above-market GFS services, e.g. Capability Centres, Accenture, interco COE, Tax COE, Global Process Owners, European Treasury Centre. Escalate through defined process (Vitalize tickets) any performance issues.

SOFT SKILLS

• Work and manage activities independently within assigned scope;  identify, analyse and solve problems requiring cross-department involvement; manage demands and expectations; report any potential delays or issues timely to line manager and partner on issue resolution, formulating recommendations on both specific actions and policies.
• Take responsibility and accountability for successful completion of assigned tasks.
• Daily/weekly/monthly work prioritization and planning guided by understanding of dependencies, complexity and compliance requirements. Flexibility to adjust to broader team priorities.
• Co-operate with other teams internally as well as with external parties (local authorities). Independently drive cross-functional deliverables and issue resolution process within assigned scope.
• Communicate clearly and appropriately at different levels of the company regarding assigned tasks. Propose communication regarding complex issues and involve line manager as appropriate.
  Ability to influence people at all levels both locally, regionally and globally.
• Apply understanding of overall end-to-end process in task execution, decision making and planning.
• Identify and drive areas for CI within assigned scope  by influencing and engaging business partners and supporting your peers and managers in delivering on a broader scope.

Required Skills & Desired Experience

• Degree in accounting or equivalent business experience.
• AAT qualified/ ACCA or CIMA part- or fully-qualified or equivalent.
• Maintains a high level of technical accounting knowledge of US GAAP or IFRS.
• Extensive experience in accounting or finance, with demonstrable experience in record to report.
• Fluent in English, Fluent in Italian would be a plus.
• Excellent computer skills with competencies in MS applications (Excel, Outlook) and major ERP platforms (preference SAP).
• Excellent working knowledge of record to report processes in a multinational company. Public accounting with a big four firm or Internal Audit with a large Corporation is a plus.
• Experience of audit and year-end close process.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key responsibilities:

• Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members 
• Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets  
• Develops country level patient recruitment strategy & risk mitigation.  Coordinates and ensures country level study enrolment targets and timelines are met 
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s 
• Assessment and set up the of vendors during study start up period (locally) 
• Investigator Meeting participation and preparation  
• Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel 
• Validation of study related materials (i.e. protocol, ICF, patient material)   
• Responsible for preparing country specific documents (e.g. global country specific amendment) 
• Prepares materials for Site Initiation Visits   
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level) 
• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues. 
• Coordination of database locks and query follow up.  Ensures timelines are met. 
• Ensure inspection readiness of assigned trials within country.  Provide support to Health Authority inspection and pre-inspection activities 
• Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. 
• Lead  study team meetings locally  
• Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable) 
• Management of Site relationships (includes CRO related issues) 
• May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs) 
• May perform site closure activities, including post-close out 
• May act as point of contact for Sites 
• May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.  
• Engage with Protocol Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally 
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations  

Requirements:

• Bachelors or Masters degree required.  Field of study within life sciences or equivalent
• Clinical Trial Manager:  Minimum of 4 years' industry related experience
• Senior Clinical Trial Manager:  At least 6 years of industry related experience
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management​
• Demonstrated organizational and planning skills and independent decision-making ability
• Strong organization and time management skills and ability to effectively manage multiple competing priorities
• Ability of critical thinking and risk analysis.
• Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
• Skilled in the use of technology
• Good verbal and written communication skills (both in English and local language).

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Bristol Myers Squibb Ireland

Bristol Myers Squibb (BMS) has been in operation in Ireland since 1964, employing over 600 people across a range of activities and business units.

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility, is part of the Global Product Development and Supply (GPS) network. This state of the art facility produces multiple therapies for the company’s growing biologics portfolio and plays a central role in Bristol-Myers Squibb global manufacturing network. The Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work for 2017, 2018 and 2019. 

Many of the global business services, including Commercial, the European Treasury Centre, Global Bio Lab and Global Logistics are based on the island of Ireland. Ireland is also home to External Manufacturing’s global headquarters, the organization responsible for the management of manufacturing and reliable supply across the Bristol-Myers Squibb global network. This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites.

The Role

BMS Cruiserath Biologics is seeking to recruit a permanent QA Technical Operations Specialist. Reporting to the QA Technical Operations Manager, the QA Technical Operations Specialist will support Qualification, Validation, Engineering, Warehouse, SAP, MES and Technical Transfer activities. The role will also support the Environmental Monitoring (EM) program and Investigations within the Multi Product Cell Culture (MPCC) Manufacturing Area.

Key Duties and Responsibilities:

• Quality Lead Coordinator (QLC) for local and complex multi-site investigations, deviations and subsequent CAPAs

• Support  site Validation and Qualification activities
• Review and approval of GMP documentation, including plans, protocols, reports, SOPs, forms, directives, policies and validation documentation
• Support the implementation and maintenance of Maximo, MES and SAP at BMS Cruiserath Biologics
• Metrics champion to ensure targets are achieved and remediation plans are in place where applicable
• QA Review and approval of investigation trend reports
• QA Lead for site change controls
• QA Lead for cross-functional projects at a site level and site representative on global projects
• QA review and approval of Annual Product Quality Review reports (APQRs)
• Support coaching of key members of the QA Technical Operations team
• Drive implementation of efficiency improvements in the Quality Department on a continuous basis and participation in site continuous improvement initiatives

Qualifications, Knowledge and Skills Required:

• A minimum of a Bachelors Degree in Science or a related technical discipline, with a minimum of 3 years’ Quality experience in the biopharmaceutical industry
• Demonstrated knowledge of applicable EU, FDA and other regulatory requirements.
• A strong technical aptitude, global regulatory experience and demonstrated experience interfacing with regulators
• A thorough understanding of cGMP requirements for areas of responsibility.
• Demonstrated in-depth knowledge of deviation and change management processes
• Ability to work on own initiative in addition to working as part of a team
• Capable of positively influencing others to bring resolution to complex issues
• Ability to work across a team matrix in order to meet accelerated timelines
• Excellent communication skills are essential
• Excellent trouble shooting and problem solving skills as well as an ability to coach and mentor individuals or teams through complex problems
• Demonstrated ability to recognise issues, highlight risks and prioritise workload based on site goals
• Excellent time management & organisational skills along with a proven ability to multi-task
• Ability to challenge the status quo with a growth mindset

What’s important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

• Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
• Innovation: We pursue disruptive and bold solutions for patients.
• Urgency: We move together with speed and quality because patients are waiting.
• Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
• Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
• Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Market Access team in Norway works with detection, analysis and solution of economic, administrative and political barriers to enable full patient access to BMS medicines in Norway. External focus, cross- functional and project-based work are key parameters for this role. The role will report to Market Access Lead Norway.

Key responsibilities:

• Support full patient access of BMS medicines in Norway, within therapeutic areas assigned by the Market Access Lead Norway. Work independently as well as cross-functionally both pre- and post-launch in the assigned therapeutic areas
• Build and maintain excellent relationships with key external stakeholders in the Norwegian

Health Care arena, e.g.: clinical thought leaders (TL’s) in relevant therapeutic area, tender organizations, Norwegian Medicines Agency, hospital pharmacies, regional medical committees, hospital and regional administration, politicians and other stakeholders with impact on medicines reimbursement, funding and recommendation.

• Lead various projects simultaneously across different therapeutic areas in conjunction with relevant Brand Teams (BT’s) and early launch teams.
• Actively identify and provide analysis of the access opportunities and challenges to the Market Access Lead and relevant BT’s and early launch teams; take responsibility for and actively participate in the development of access plans to reach best impact from cross-functional collaboration.
• Understand the Norwegian Health Care systems organizational structure and the decision making process in regions and at national level; micro and macro level.
• Understand administrative and political mechanisms used to steer health care. Use this knowledge actively in BT’s and early launch teams.
• Understand the Norwegian purchasing and tender system.
• Follow and analyze development trends. Examples of analysis include, but are not limited to: patient’s access to medicines (“patient path ways”), financial resources and budgeting, regional and hospital formularies’ (pre- and post-launch), health policy initiatives.
• Create solid market access plans for launch products in close collaboration with the brand team.
• Plan, follow up and implement pricing, funding and tender stratgies
• Create strong and evidence based value communication presentations and deliver them across clinical, administrative and political stakeholders
• Create high-quality partnerships between stakeholders in the health care sector and BMS;
• Leverage the commitment of BMS for professional support and services and thus help to promote BMS Norway’s image.

Expected areas of Competence (i.e. skills and abilities) and knowledge desired:

• Ability to generate innovative ideas/solutions.
• Strong network in the Regional Health Authorities - Regional medical committees and  Regional administrations
• Experience from the Norwegian health care sector
• Relevant education, professional knowledge and experience
• Health economics and governmental affairs
• Understanding of patient access systems in hospitals and open care
• In-depth knowledge of pharmaceutical market and health care environment
• In-depth knowledge about the Norwegian tender and purchasing system
• Understanding of customer constraints and the health care environment in Norway
• Strong analytical, account planning and project management skills
• Demonstrated ability in value-based communication
• Clear focus for influencing and negotiating with access stakeholders across a variety of therapeutic areas.
• Proved track record of collaboration within colleagues and matrix environments
• Ability to communicate effectively and persuasively on complex clinical and economic matters to clinicians and payers in an emerging and changing healthcare system
• Ability to communicate and operate in English

Experience desired:

• Relevant university degree, 
• Experience within Norwegian public health care administration
• Experience within the Norwegian or similar pharmaceutical market
• Experience with Market Access from the pharmaceutical industry

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility.  This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020.  

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

BMS Cruiserath Biologics is seeking to recruit a permanent Project Management Office ( PMO) Manager to manage the PMO for the organisation. In this position you will be charged with the oversight and management of the site strategic PMO. As PMO Manager you will oversee the selection, execution and closeout of the projects/ programs which have been identified as key to the delivery of the site and company strategy.

Key Duties and Responsibilities:

• Develop and implement standardized program / project management processes  and tools to facilitate and assess project planning, program budgeting, risk identification and management, change management , program governance and program / project status reporting.
• Ensure and manage effective business governance processes to support the day to day business performance.
• Ensure site strategy, objectives, and key projects in the portfolio (including updates) are clearly communicated across to the organisation .
• Ensure processes are aligned with Global Planning and Supply (GPS) PMO standards and integrated with other relevant site and GPS business process.
• Ensure all executed projects and programs are aligned with the site strategic plan
• Develop integrated, detailed plans for executing the PMO portfolio, including capture and prioritization of programs, assigning of resources and setting of key milestones.
• Lead overall program governance and reporting to key stakeholders, Leadership teams and the Global Planning and Supply (GPS) PMO team.
• Oversee the process for realization and capture of benefits from the programs/ projects.
• Facilitate cross –site, cross functional interactions and provide support between sites and HQ functions as required.
• Lead positive conflict and issue resolution at portfolio and program team level. Facilitate decision making and development of remediation plans.
• Provide training and coaching to Program Sponsors, Managers and Lead End Users.
• Manage Program /Project lessons learned processes and the continuous improvement of the PMO.
• Lead strategically important initiatives, assuming the role of Program/ Project Manager.

Qualifications, Knowledge and Skills Required:

• Bachelors degree in Sciences, Engineering or business administration.
• A minimum of 5 years leadership experience in project /program management.
• Extensive experience working within the Biopharma/ Pharma manufacturing and supply environment
• The candidate will have proven decision making ability, strong communication skills and the ability to work well and influence cross functionally.
• A qualification in project and program management is required.

What’s important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

• Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
• Innovation: We pursue disruptive and bold solutions for patients.
• Urgency: We move together with speed and quality because patients are waiting.
• Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
• Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
• Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose/Objective of the job

• Responsible for activities related to study start up and ongoing study document management
• Act as point of contact for local study teams and external stakeholders

Key Responsibilities and Major Duties

• Independently manages multiple country, study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.
• Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines
• Prepare country Informed Consent Form (ICF) and manage country ICF template
• Review and approval of Site ICFs
• Review and approval of Clinical Trial Package (CTP) documentation
• Update national registries as applicable
• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
• When applicable, conduct drug/IMP label review & translation
• Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
• May support the collection and distribution of documents from / to sites including obtaining insurance certificates
• May support Health Authority inspection and pre-inspection activities
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
• Serves as an SME for key investigational sites. Documents and maintains relevant information on the site’s structure, start-up processes, key contacts, etc (i.e., Site Playbook) for sharing with internal team members.
• Represents BMS in local (e.g. pharma association or HA driven) working groups around start up processes in the country
• Represents BMS in meetings discussing local requirements / repetitive questions from local Health Authority and Ethics Committees
• Proactively works with stakeholders (e.g. document template owners, GRS, CMC, CSO) to prevent questions from HA based on observed past questions.
• Constantly analyse the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.

Internal Stakeholders;

• Protocol Manager (PTM), Clinical Trial Managers, Clinical Trial Monitors, Clinical Trial Associates (CTA), Site Relationship Managers, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Line Managers(LM), Head of Clinical Operations , local Regulatory, local Medical Affairs and Clinical Supply team members

External Stakeholders;

• Principal Investigator, Sub-Investigators, Study Coordinators, Research Nurses, Research Managers, Data Managers, Pharmacists, IRB Personnel, Regulatory agencies (as applicable), Vendors

Requirements

• Bachelors or Masters Degree within life sciences or equivalent
• Study Start-up Specialists – Minimum of 1 year industry related experience.
• Senior Study Start-up Specialists - 5 years or more of industry related experience that includes significant experience in coordination of trial start-up activities and support to Health Authority / Ethic Committee submissions
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Demonstrated organizational and planning skills and independent decision-making ability
• Strong organization and time management skills and ability to effectively manage multiple competing priorities
• Ability of critical thinking and risk analysis.
• Good verbal and written communication skills (both in English and local language).

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary:

Accountable for leading and coordination of the site utilities infrastructure, systems and equipment,  including GMP  Heating, Ventilation & Air Conditioning, (HVAC) system activities, clean utilities, Water for Injection and Clean Steam (CS), generation / distribution systems and site Energy Program. Also, accountable for the plant High Efficiency Particulate Air (HEPA) filters certification program to fully comply with applicable manufacturing and regulatory requirements. Must comply with all security Guidelines, Environmental, Health & Safety regulations and the current Good Manufacturing Practices required by the job function.

Responsibilities:

1.    Leads the site Energy Management Program including the identification and implementation of effective energy savings initiatives and projects.
2.    Administers Plant High Efficiency Particulate Air (HEPA) filters certification program to fully comply with applicable manufacturing and regulatory requirements assuring:
-    HEPA filters certification are conducted as required by established frequencies. 
-    Documentation of  HEPA filters is revised and approved by Quality Assurance, Manufacturing and Engineering Areas prior to close the certification process.
-    An adequate inventory levels of HEPA filters in stock for replacement of filters as required.
-    The HEPA Filters certification Program Standard Operating Procedure development and/or maintenance (Assure procedure is up to date with current regulatory standards and requirements).
3.    Performs HVAC System balancing and differential pressures adjustments as required by manufacturing areas requirements and  
maintains all related documentation and files of all HVAC balancing, differential pressures adjustments and HEPA filters of the plant HVAC System.
4.    Defines and implements an Air Handling Replacement program and develops the required Capital Appropriation Request to replace AHU’s.  
5.    Supports the maintenance personnel during HVAC system troubleshooting.  
6.    Provides Subject Matter technical expertise for equipment ensuring continue compliance to regulatory company and site policy and procedure 

7.    Reviews and approves all new HVAC, WFI and CS  systems’ design.  
8.    Identifies and analyzes equipment and systems failure causes and develops corrective measures to avoid reoccurrence.
9.    Coordinates external maintenance contracts services and non-routine maintenance activities
10.    Assures maintenance related documentation complies with the current Standard Operating Procedure of Good Documentation Practices.
11.    Reviews predictive, preventive maintenance Job Plans for all HVAC, WFI and CS equipment and systems to assure compliance with applicable procedures.
12.    Supports Reliability Centered, Predictive, Preventive and Corrective Maintenance activities and recommends changes or implement changes as required. 
13.    Evaluates all HVAC units, WFI and CS  relevant operational data, reports, statistics and documentation related to identified critical equipment and systems in order to generate proactive and timely actions to optimize availability and reliability of equipment and; prepares failure analysis reports, concentrating on identifying repetitive occurrences and take appropriate actions as needed.
14.    Evaluates HVAC equipment, WFI and CS maintenance conditions and submit recommendations to site management for improvement. 
15.    Manage compliance efforts related to Deviations (QE’s), CAPA and change management.
16.    Participates on regulatory audits as SME of our GMP clean utility systems (HVAC, WFI, and CS)
17.    Evaluates and review BMS quality directives related to our GMP clean utility systems (HVAC, WFI and CS)
18.    Leads and develops the BAS, QBAS M and QBAS system requirements for HVAC monitoring.  
19.    Conducts energy conservation assessments and implement control changes to optimize HVAC systems performance.
20.    Coordinates with Project Engineers maintenance new projects reviews to assure that new equipment and systems are design, developed and constructed following adequate maintenance practices such as adequacy of space, equipment location, materials of construction, etc.
21.    Supports other Engineering & Maintenance Department functions as required by plant needs and unplanned events.

Knowledge/"Skill:

• BS Degree in Mechanical Engineering
• Five (5) years of experience in utilities maintenance, WFI , Clean Steam and HVAC System Operation or HVAC System Design and Energy programs
• Possess proven administrative and computer literacy background and abilities
• Able to analyze large databases and field observations to indicate weaknesses/ failures of equipment and systems
• Able to communicate fluently in English and Spanish (verbal and written). Must have excellent communications, analysis, organization and leadership skills
• Ability to exercise accurate judgment and to evaluate information critically
• Experience with HEPA filters certification program and with HVAC systems requirements for aseptic areas and thorough knowledge of applicable standards and regulations
• Good teamwork skills
• Capacity to interact effectively with people
• Able to exercise good judgment in special situations
• Ability to keep work pace and/or meet deadlines
• Willing to work irregular hours, rotative shifts, weekends and holidays