Global Compliance Operations Cover Letter

I submit this application to express my sincere interest in the global compliance operations position.

Previously, I was responsible for advisory to Business and Functions on KYC/AML related issues.

My experience is an excellent fit for the list of requirements in this job:

• Experienced in managing and developing training for medical affairs
• Experience with strategic thinking to identify and address risks and hurdles in a timely fashion
• Negotiations skills across hierarchical levels to align and develop functional processes and address different needs
• Significant supervisory/leadership experience managing people or multiple projects
• Excellent leadership, self-management and organizational skills
• Strong working knowledge of US and International pharmaceutical laws, regulations, and guidance, such as US federal and state anti-kickback laws, international prohibitions against off-label promotion, US federal Sunshine law, EFPIA codes on HCP interactions, disclosure, and interactions with patient advocacy organizations, US Foreign Corrupt Practices Act, UK Bribery Act, so can guide the business and explain the “why” behind Amicus policies and training
• Meticulous documenter
• Experience with Lexis Nexis, Excel and/or Tableau preferred

Please consider me for the global compliance operations opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for kYC/AML support to designated business areas and to countries within the regions as required.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Talent selection, development and engagement
• Adhere to SLA’s/SOP’s and resolve operational issues for the team
• Experience building a new business or organization
• Trade related specialization/ license/ certification (Broker’s license
• Advanced Skills in MS Excel, Access, and ERP query tools
• Proficient in Microsoft Outlook and Office with expertise in Microsoft Excel
• BA/BS or equivalent experience, preferably in customs
• Drive continuous improvements of site systems & processes against current Compliance requirements and influencing key stakeholders on recommended Compliance improvements

I am excited to be applying for the position of global compliance operations. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for internal training as necessary AML, anti-fraud, and KYC, other necessary compliance matters.

Please consider my experience and qualifications for this position:

• Thorough knowledge of applicable international GxP regulations and standards
• Sound pharmaceutical industry awareness and understanding, especially with respect to quality and regulatory requirements
• Strong mature leader with influencing skills
• Capable of identifying and mitigating risks
• BS/BA in science or related field
• Exposure to project management & process improvement techniques will be an added advantage
• Pharmaceutical and/or Medical Device industry experience directly involved with the collection and creation of a variety of Trial Master File (TMF) content is preferred
• Demonstrated experience in the conduct of inspection-readiness activities preferred

I would like to submit my application for the global compliance operations opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for oversight and support to the business with respect to firm AML and KYC requirements.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Experience with activities related to regulatory and internal inspections preferred
• Knowledge of the drug development process, including International Council on Harmonization (ICH)/Good Clinical Practices (GCP), and local regulatory requirements preferred
• Knowledge of DIA TMF Reference Model preferred
• Intermediate knowledge of anti-money laundering typologies related to the payments and e-commerce space
• High level of personal integrity, interest in payments as evidenced by related work experience, proven dedication to excellence, leadership qualities and a flexible, creative, innovative approach to problem solving
• Familiarity of SQL and data querying skills a huge preference!
• Trade compliance risk management experience
• Result driven performance

I am excited to be applying for the position of global compliance operations. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for subject matter input regarding content development and identification of audience for key AML/KYC training courses.

Please consider my qualifications and experience:

• Host/lead/manage inspections of site by External Customers, internal assessors, and Regulatory authorities
• Strong knowledge of global regulatory and cGMP requirements, industry best-practices
• Strong familiarity with production operations
• Strong leadership, project management, and technical writing
• Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 11/50/54/56/812/820) ISO14155/13485, ICHs, and other applicable regulations
• Demonstrated knowledge of and experience working in global compliance programs
• Significant experience drafting policies, procedures and other guidance documents
• Organized individual who displays initiative