CGI Technologies and Solutions, Inc. Senior Life Sciences Consultant-Regulatory Operations in Burlington, Massachusetts
Senior Life Sciences Consultant-Regulatory Operations
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Senior Life Sciences Consultant-Regulatory Operations
Category: Business Consulting, Strategy and Digital Transformation
City: Burlington, Massachusetts, United States
Position ID: J0419-1668
Employment Type: Full Time
Become a member of CGI as we collaborate with our Life Sciences clients to transform the way they work today and enable their path forward. CGI’s capabilities and our client engagements will offer you an exciting path for growth. We strongly encourage and facilitate our members’ development through various avenues including leading engagements, developing new service offerings, designing solutions, and preparing proposals. Our practice’s focus on the New England region allows our consultants to work predominately with local clients, while CGI’s national and international operations offers opportunities for travel if desired. We are seeking candidates with strong core consulting and analysis skills, who will be flexible, and able to play a variety of roles depending on the engagement. If you are looking to make your career journey extraordinary while delivering innovative client projects, come and be a part of CGI’s continued success.
Your future duties and responsibilities:
As a Senior Life Sciences R&D Consultant, your future responsibilities and duties will include:
• Managing and leading R&D advisory projects
• Acting as a subject matter expert or domain lead on engagements
• Delivering the business process transformation and change management aspects of large scale programs
• Performing business analysis, including structuring the project approach, analysing data from interviews, workshops, and documents, and developing solutions
• Deepening CGI’s relationships with its clients by providing valued advice and identifying unmet needs
• Contributing to the practice through thought leadership, offering development, and mentoring other team members
• Develop proposals for new opportunity pursuits at existing and potential clients.
Required qualifications to be successful in this role:
• 5+ years experience in pharmaceutical or biotech Regulatory Operations.
• 3+ years consulting experience.
• Experience defining future state business processes within Regulatory functions.
• Demonstrated project and operations management experience and/or strategy development and business management A keen, flexible and aggressive intellect; superior conceptual thinking as well as analytical and problem solving skills
• Strong communication skills, both verbal and written, at all levels
• Proven record of creating and maintaining business partnerships and relationships
• Demonstrated ability to effectively collaborate with cross-functional virtual teams as well as independently
• Knowledge of Regulatory guidelines such as US FDA, EU, ICH, GCP, GMP and ISO.
• Experience in gathering and documenting requirements, Business Process Analysis, Change Management Concepts, Current/Future State Analysis
• Highly organized, details and results oriented
• Able to work under tight deadlines
• Strong Microsoft Excel and PowerPoint skills
• Interest in applying new or existing technologies to address client challenges.
• Desire to contribute to developing of more junior team members through mentoring.
• Strong Microsoft Visio skills
• Experience working in an Agile development environment
What you can expect from us:
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com .
No unsolicited agency referrals please.
CGI is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned .
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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.