The WRD Operations Director will be accountable for supporting the operations and infrastructure that enable WRD colleagues to publish and/or present Pfizer-supported publications and presentations containing non-clinical content in accordance with applicable laws, regulations, industry codes, and internal policies. The Director will lead the development, revision, and/or harmonization of policies, procedures, training materials, systems, monitoring plans, and remediation plans in order to ensure compliance with internal compliance requirements and external laws, regulations and codes globally.
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Responsibilities
The major responsibilities will include but are not limited to:
• Serve as the Business Process Owner for WRD Non-Clinical Disclosures Guideline and WRD Conflicts of Interest SOP 203
• Ensure consistency, operational efficiencies and business adaptation of policies and procedures
• Ensure guidance is clear, concise and easy to understand; update documents as necessary and develop efficient processes to facilitate compliant execution
• Help ensuring consistency in processes, controls and training for data management
• Partner with key stakeholders throughout Legal & Compliance including WRD Attorneys, Corporate Compliance, and across WRD to create and/or review compliance guidelines and other compliance related documents
• Develop and provide live, online and virtual training as well as other resources with input from Legal and Compliance to ensure adherence to applicable laws, regulations, industry guidelines and Company policies
• Partner with appropriate groups to develop monitoring plan; ensure reporting to WRD leaders; and implementation of remediation/monitoring plans
• Partner with key stakeholders throughout Legal & Compliance, including WRD Attorneys, on inquiries and ad-hoc requests; analyze trends to create and execute a plan to address compliance or process needs
• Identify continuous process improvement opportunities to facilitate more efficient, effective and compliant processes through technology or process enhancements
Liaise with Legal and Compliance to keep apprised of existing and upcoming laws and industry guidelines or trends and work with Legal and Compliance to effectively disseminates changes or trends internally
Qualifications
• At least 8-10 years’ of applicable experience in Compliance/Operations and Pharma
• Bachelor’s degree; JD, MBA or PhD preferred
• Scientific/clinical experience; compliance and/or 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 Pfizer organization preferred
Travel to various Pfizer sites as needed.
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