About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Sr Manager/Associate Director, CE Compliance Operations will assist the Director, CE Compliance Operations in the design, implementation, and oversight of operations and infrastructure that enable the company R&D colleagues to engage with external customers, including healthcare professionals, academics, and scientists in accordance with the company policy and applicable laws and regulations. The individual in this role will have a strong understanding of healthcare compliance and continuous improvement principles and will be accountable for developing executable plans to improve processes, increase operational efficiency, reduce cost, track and report productivity, and ensure implementation of operational processes in support of functional strategies. Responsibilities include maintenance of divisional policies and procedures, training development and delivery, supporting colleague understanding of applicable compliance policies and procedures, and leading remediation efforts. This position will also lead the development of functional SOPs to ensure consistency and business continuity within the compliance operations team.
• Manages execution and completion of Customer Engagement (CE) related processes to ensure R&D colleague needs are met while ensuring consistency and compliance in processes to establish best practices
• Leads training and communications planning
• Assists with managing multi-functional teams
• Assists in evaluating and establishing procedures; proposes operational solutions and strategies that ensure our systems optimally support our processes and deliver value to the company
• Manages the development and ongoing maintenance of divisional CE policies, procedures and systems
• Coordinates monitoring results and facilitates remedial action; identifies and communicates executive corrective action plans when issues are identified
• Maintains a thorough and sophisticated knowledge of existing and upcoming laws and industry guidelines or trends and effectively disseminates internally
• At least 5-7 years' of applicable experience in Compliance/Operations and Pharma
• Bachelor's degree; JD or MBA preferred
• Experience in healthcare compliance policy and training development; compliance operations experience is preferred
• Ability to work autonomously, manage multiple issues/projects simultaneously and work well under pressure
• Agile learner who can adapt to a dynamic environment and nimbly shift priorities as necessary
• Demonstrated skills for guiding process improvements and new process implementation/change management
• Excellent written and verbal communication skills, including presentation capabilities, interpersonal skills and conflict resolution
• Ability to work within a matrixed global organization and develop a strong, effective network of colleagues
• Pharmaceutical industry experience and familiarity with the company organization preferred
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to various the company sites as needed.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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