Regulatory and Compliance Life Sciences Manager|
Compensation: $128K - $169K / Year
Minimum Education: Bachelors
Job Type: Full Time
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Regulatory and Compliance Life Sciences Manager
Arthur L Crume
*Recent consulting background preferred over Industry candidates.
*Experience in Regulatory and Compliance focus in medical devices preferred. *Experience managing engagements and teams up to 10 individuals.
*Life Sciences experience required.
** Ability to travel Monday-Thursday (Boston, NJ, NY and PA) is expected.
No Relocation Assistance Available
My client is a collaborative, entrepreneurial firm that is part of a dynamic, global organization of more than 47,000 people serving clients in more than 140 countries with the agility and focus it takes to be a leader.
This organizations Advisory professionals are progressive thinkers who create, protect and transform value today in order for their clients to have the opportunity to thrive and grow.
Their advisory practice creates holistic solutions delivered by innovative, curious professionals who bring technical depth and industry insight to clients.
Business Risk Services protects value.
This company's Business Risk Services (BRS) practice includes Risk Advisory Services, Forensic Advisory Services and Data Analytics.
The Life Sciences Regulatory Risk Compliance Manager assists clients in developing and executing regulatory risk strategies delivering projects on time, on budget, and with a high level of quality that promote innovation and growth, operational efficiency and process excellence and sustained regulatory compliance across the life sciences value chain.
Essential Duties and Responsibilities:
Perform project engagement responsibilities including project planning, execution and risk management, client management, subject matter expertise and guidance, project financials, and performance reviews for project team members.
Support business development activities throughout the entire sales cycle, client relationship building, opportunity creation/identification, opportunity qualification, proposals, statements of work, oral presentations, developing project approaches, resource models, and pricing estimates.
Develop and present thought leadership in the forms of point-of-views (POVs), whitepapers, conference presentations, and industry articles.
Promote innovation through research and creative thinking of clients’ future needs and developing new solutions and services to address them.
Meet or exceed targeted billing hours (utilization).
Maintain a good working relationship with clients and work effectively with client management and staff at all levels to gather information and perform services.
Work closely with senior managers and partners to promptly identify and resolve client problems or issues.
Communicate (verbally and in writing) externally with clients and internally with all levels of the organization to successfully accomplish objectives portraying knowledge and confidence.
Develop, train, manage, coach, and mentor senior associates and staff on projects and assess performance for engagement and year-end reviews.
Motivate others to perform at maximum efficiency without sacrificing quality of the services delivered.
Assist management with proposals and business development.
Interview campus and/or experienced candidates.
Other duties as assigned.
*Bachelor's degree in Biomedical Engineering, Biology, Chemistry or other life sciences-related discipline.
*Graduate or professional degree is a plus.
*5-10 years of life sciences industry experience with a specialization in regulatory compliance, product quality, and risk management across both biopharmaceuticals and medical device and diagnostics.
*Demonstrated business development experience including client relationship building, opportunity creation/identification and opportunity qualification experience.
*Demonstrated consulting experience preferably at a professional services firm servicing life sciences clients at a national level.
*ASQ, RAPS or related license/certification a plus.
*Communications skills (e.g. Excellent verbal and written communication skills).
*Ability to work additional hours as needed and travel to various client sites with up to 80% travel required.
The company promotes a nationally recognized culture of health and offers an extensive array of benefits to meet individual lifestyles.
It is this organizations policy to promote equal employment opportunities. All personnel decisions, including, but not limited to, recruiting, hiring, training, promotion, compensation, benefits and termination, are made without regard to race, creed, color, religion, national origin, sex, age, marital status, sexual orientation, gender identity, citizenship status, veteran status, disability or any other characteristic protected by applicable federal, state or local law.
ALC Staffing Associates
509 N Vermilion
Danville, IL 61832