Business Analyst - Drug Product Lifecycle Management

Company Description

LabAnswer is the leading and largest laboratory informatics consultancy; combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions.

LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations.

The LabAnswer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects.

Job Description

Please feel free to apply directly for this position at: https://chm.tbe.taleo.net/chm01/ats/careers/requisition.jsp?org=LABA&cws=1&rid=599

At LabAnswer, we are looking for a Business Analyst with expertise in clinical and commercial drug product lifecycle management using the Oracle Agile platform. Responsibilities of this position include analyzing and recommending improvements to business processes both internally and in collaboration with external partners; eliciting and documenting business and functional requirements; and participation in change management, end user training and post-deployment support to enable streamlined lifecycle management of clinical and commercial drug products.

The successful candidate will be an independent self-starter with expertise in drug development and a passion for working in a cGMP laboratory informatics environment.

Business Process Analyst Duties:

• Analyze business partner's operations to understand their strengths and weaknesses and determine opportunities to automate processes and functions

• Lead process design workshops and interview scientists, lab managers, IT teams, training teams, and other stakeholders

• Document business processes using customized Business Process Modeling Notation in MS Visio and/or enterprise architectural tools

• Collaborate with business partners and IT technical teams to define, plan, champion and implement process improvement initiatives including system implementations or enhancements

• Research & recommend best practices to streamline, simplify, and increase compliance of the business process; analyze the root cause of risks or issues and provide solutions

A qualified candidate will possess:

• Experience in drug discovery, clinical development and commercial manufacture processes and lab informatics or quality management systems (Documentum, Veeva or similar Document Management Systems, Trackwise or similar incident management systems, Oracle Enterprise Business Services or similar ERP systems)

• Ability to analyze information and use logic, LEAN and Six Sigma principles to address work-related issues and problems

• Ability to effectively drive change while maintaining and enhancing internal customer relationships

• Possess an understanding of business and technological trends and use this knowledge to bring solutions to process development end users to enhance the enterprise's competitive edge

• Work with project teams to ensure compliance with regulatory requirements such as FDA, EMEA, CLIA, as well as internal policies and processes

• Demonstrated ability to produce clear and compelling written communications targeted to scientific, IT and leadership team members

Qualifications

Basic Qualifications:

• Ability to effectively communicate, both verbally and through electronic media

• Ability to work on complex projects with minimal guidance

• Proven success working within matrixed teams

• Strong team player who is able to collaborate with colleagues and business stakeholders on complex tasks distributed across multiple geographic locations

• Prior work experience that demonstrates effective analytical thinking, strong customer service skills, and attention to detail

• Must be local to the San Francisco Bay Area or willing to travel 50%

Education:

Bachelor Degree in a related discipline and five+ years of systems implementation and analysis experience. Emphasis should be on laboratory tools for Clinical, R&D or Quality groups of an FDA regulated environment.

Additional Information

We offer comprehensive benefits to regular full-time employees including but not limited to:

•Unlimited ceiling for professional growth opportunities within LabAnswer

•You will also have opportunities to take advantage of training programs to advance your career; our extensive online library includes a assortment of technical and professional training tools and resources

•Opportunities to work across a variety of industries (Pharmaceutical, Medical Device, Consumer Products, Energy, Environmental, Forensics, Genomics, Government etc.)

•Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical, public health and research hospitals) •Comprehensive health and welfare programs to fit your individual or family’s needs:

•Health Insurance •Dental Insurance •Vision Insurance,

•401(k) Retirement Saving that includes a generous employer match

•Paid Time Off (vacation, sick, holiday)

•Company Paid Life Insurance

•Company Paid Short and Long Term Disability Insurance

•Wellness Plans and Rewards

•Strong company values of team work, culture and values, personal and professional development, work-life balance, and recognition

•Competitive compensation with opportunities to participate in employee bonus plan and travel bonus plan

At LabAnswer we offer a very competitive compensation package based on experience and education. We are looking for exceptional people to join our team, those who are looking to join an organization for the long term. We invite you to visit www.labanswer.com to review our Employee Value Proposition and Philosophy, and welcome you to apply, or refer a candidate to apply, through our careers page for employment consideration.