Director, Safety Cover Letter

I submit this application to express my sincere interest in the director, safety position.

In my previous role, I was responsible for statistical subject matter expertise to clinical/medical groups and Biostatistics staff in preparing analysis plans for reporting clinical trials results, determining details of data analysis and statistical methods, and formatting tables/listings/graphs for result presentation.

Please consider my qualifications and experience:

• Part 121 experience
• Knowledge of Clery Act requirements
• Knowledge of Title IX compliance for institutions of higher education
• Knowledge of local training program and local operations
• Knowledge of best in class safety and training programs
• Previous experience working in medical safety
• Managerial, organizational, and leadership skills in a dynamic environment running multiple clinical trials
• Strong working knowledge of relevant U.S. and international regulatory requirements and excellent knowledge of FDA and international guidelines

I submit this application to express my sincere interest in the director, safety position.

Previously, I was responsible for leadership over clinical trials for current CDx development and partner programs and strategic guidance on anticipated pre/post market clinical trials including internal product validation studies and marketing studies.

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:

• Subject Matter Expertise in core risk areas, control systems, and safety regulations
• Solid employee relations experience, interpersonal and verbal/written communication skills
• Safety management experience in a related industry
• OSHA 501 30hr instructor
• Proficiency in MS Office applications (Word, Excel, PowerPoint, Visio, SharePoint )
• Confined Space Awareness training certificate
• American Heart Association CPR/AED certified
• Certified in aerial platform, boom lift, fork lift

Please consider me for the director, safety opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for dynamic leadership, strategic direction and global oversight of key pharmacovigilance activities across Moderna’s portfolio and throughout the clinical development and post-marketing phases of the life cycle including:.

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:

• Assist in evaluating field operations and corporate-based support functions' business processes and initiatives to ensure effective safety practices
• Develop, deliver and manage Sundance Security and Workplace Safety Programs
• Conduct other duties as assigned by the President of Sundance
• Certified Safety Professional (CSP) or International Society of Safety Professionals (ISSP) certification preferred
• FAA Commercial-Instrument
• Class I or II medical certificate
• Possesses sound judgment and objectivity in decision-making
• Experience with a large fleet of vehicles and safety programs for employees

I would like to submit my application for the director, safety opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for clinical leadership to allow for initiation of trials in EU in collaboration with regulatory and clinical operations team members.

Please consider my experience and qualifications for this position:

• Manage and conduct safety assessments, trend analysis, audits, incident investigations, and site inspections
• Partner with various departments to analyze, develop, implement, and maintain safety-related policies, standards, procedures, and programs
• Lead efforts to minimize and mitigate risks throughout the organization, including industrial hygiene, safety, environmental, and facilities
• Provide vision, direction, and alignment with Academy’s safety efforts
• Manage daily activities of the safety team
• Implement and maintain non-insurance risk management programs and procedures to drive continuous safety performance improvement
• Monitor and audit field activities to ensure safety compliance
• Develop root cause analysis studies of incidents and hazards in an effort to identify and implement safety measures

I am excited to be applying for the position of director, safety. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for strategic US Medical input to Global Development on clinical development pre-registration, label extension, pre- and post-market launch strategies, and life cycle management.

Please consider my qualifications and experience:

• Maintain an effective balance of technical writing and creativity / communication to create highly refined work products for nationwide facility use / implementation
• Proficient with modern Microsoft Windows Office software such as Word, Excel, PowerPoint, and Outlook email
• Eligible for Professional Engineers Ontario (PEO) Certification
• Experience managing RAMS Engineering lifecycle activities and/or managing auditing and assessment activities
• Extensive knowledge of railway signalling principals is desirable
• Hogere Veiligheidskunde (HVK) or Master of Safety, Health and Environment Management (MoSHE), professional certifications and/or Green Belt and Lean/Six Sigma experience
• Experience with occupational exposure control system strategies – prevention, engineering controls, work practice controls, and personal protective equipment (PPE) including respiratory protection
• Familiar with regulatory requirements for occupational exposure, including EU Directive for Worker Protection for CMR Substances and EU Directive on Chemical Agents