Compliance & Risk Management Cover Letter

I would like to submit my application for the compliance & risk management opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for guidance on and ensure compliance with relevant regulations applicable to GH&CR activities, including industry codes and Novartis internal policies & procedures.

Please consider my experience and qualifications for this position:

• Cyber Certifications
• Direct experience with compliance-related issues and activities
• Requires experience working across multidisciplinary areas of preclinical and clinical development (including pre- and/or post-commercial activities)
• Strong knowledge of the drug development process, international risk management standards and scientific and quality terminology
• Knowledge of GxP regulations and guidance
• Proactive strategic thinker with strong innovative problem solving skills
• Conflict management/negotiation/influencing skills
• Experience working with multidisciplinary functional leaders (director level and above)

I would like to submit my application for the compliance & risk management opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for compliance guidance in regulatory change, business change and/or issue management related projects as well as during regulatory audits and examinations - Provide compliance review of business line procedures and customer communications in applicable systems.

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:

• Proficient in programming and scripting languages for data science and analysis including SQL
• Compliance experience in Futures, financial and physical commodities trading
• Spanish language skills would be an advantage
• Working knowledge of EPA Part 79 & 80, regulations and reporting requirements
• Experience with regulatory Exams
• Experience in pharmaceutical or biotechnology drug development
• Basic knowledge of international GxP drug development regulations, including USA (FDA), EU (EMA, MHRA), Japan (PMDA), and ICH Guidelines
• Working knowledge of MS Word, Excel, PowerPoint, SharePoint, Outlook, and audit management systems

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

In the previous role, I was responsible for proactive and timely communication of regulatory developments and compliance obligations (research of existing, amended or new legislation/regulations) to stakeholders and take appropriate action to ensure compliance with new or amended regulations;.

Please consider my experience and qualifications for this position:

• Extensive knowledge of sponsored programs regulations in particular Uniform Guidance and related areas of regulatory compliance
• Understanding levels of potential risks and how to address each risk
• Experience in sponsored programs administration in a university, hospital, or non-profit research setting
• Designation of Certified Research Administrator (CRA) or Certified Financial Research Administrator (CFRA)
• Advanced knowledge of Excel, Business Objects, Access, PowerPoint & Tableau
• Advanced conflict management and problem resolution skills in managing internal and external customer relationships
• Identify and define plans for risk mitigation and opportunity
• Collect, organize and analyze information to monitor the effectiveness and efficiency of processes and systems

I submit this application to express my sincere interest in the compliance & risk management position.

In the previous role, I was responsible for compliance Services to colleagues regarding regulatory (GxP) and Data Privacy compliance for projects and ongoing service delivery.

Please consider my experience and qualifications for this position:

• Work closely within Q&OP functional infrastructure and Integrated Technology Teams (ITT’s) to provide day to day support of structure, processes, procedures, artifacts, and awareness/training needed to meet business objectives
• Support and monitoring the compliance programs, including responding to government investigations and queries
• Pro-active, a team player capable of prioritizing own work and handle multiple tasks
• Excellent written and oral communication skills in English and Chinese (Mandarin)
• Intermediate to advanced MS Office skills including Word, PowerPoint, Excel skills, including v lookups, pivot tables, macros, charting and formulas
• Leans into a challenge - turns problems into opportunities
• Previous experience working in a web services, cloud, and user interface design environment
• Entrepreneurial spirit, with a track record of delivering results

I would like to submit my application for the compliance & risk management opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for compliance and regulatory advice and analysis in relation to relevant business initiatives, projects, issues or events to ensure compliance with all relevant laws, regulations and policy.

Please consider my qualifications and experience:

• Knowledge and experience in Antitrust, Antibriberty & Corruption, Privacy, Fraud Prevention
• Proven success with project management, continuous improvement, SSAE, HiTrust or other control methodologies
• Successful at working independently
• Skilled at presenting to varied groups, including senior executives
• Prior demonstrated experience in compliance organizations
• Experience with Excel, Access, and Database Architecture will be helpful for some of the internship opportunities but not needed for all
• Proven leader with strong analytical skills, able to balance and prioritize business needs with security and compliance goals
• Ideally some compliance or risk management experience (although this is not essential)