Sanofi
Healthcare
R&DSubmission&DocumentServicesLead
“R&D Submission & Document Services Lead at Sanofi. Skills: Team Leadership, Documentation Management, Process Excellence, Talent Development. Provide direct supervision and management. Contribute to revisions/updates of work instructions”
What You'll Achieve.
Deliver high quality, compliant documents and dossiers; Support departmental goals and quality standards; Support effective change management; Ensure completion of related on-boarding documentation procedures; Achieve new levels of effectiveness; Progressing the pipeline via timely and high-quality documents and dossiers; Efficiently deliver top quality documents and timely submissions; Confirm that all processes and procedures are being followed; Confirm that timelines will be adhered to; Confirm all Sanofi and Health Authority standards are met; Ensure staff is delivering activities in a timely and high-quality fashion; Meet organizational pipeline submission demands; Assist in compilation of departmental metrics and performance goals; Drive efficiencies
Industry & Context.
Identify critical submission or publishing issues; Propose creative and achievable solutions; Determine the causes and find efficient solutions; Support submission and technical issue resolution
Operate with discretion and confidentiality about sensitive data
What They're Looking For.
Must Have
Extensive experience in the pharmaceutical industry, Diverse regulatory experience, Regulatory operations experience, Technical aptitude with various software/troubleshooting, Demonstrated ability to lead teams, Collaborate with functional partners, Operate with discretion and confidentiality about sensitive data, Excellent verbal and written communication skills, Manage simultaneous priorities, Lead projects, Proven track record to meet timelines, Attention to detail, Apply project management skills, Advanced working knowledge of eCTD standards, CTD methodology, Identify critical submission or publishing issues, Propose creative and achievable solutions, Determine causes and find efficient solutions, 5+ years’ experience in managing teams in a matrixed environment, Demonstrated leadership abilities, Negotiating/influencing skills, Effective people management, Bachelor's degree, or equivalent
Nice to Have
Master's degree
What You'll Do.
Provide direct supervision and management
Contribute to revisions/updates of work instructions
Train team members on processes
Global Submission Management
Provide oversight to support departmental goals
Oversee standards and process efficiencies
Support effective change management
Oversee onboarding of new team members
Embody and promote the One Sanofi vision
Deliver top quality documents and timely submissions
High-level oversight of document preparation
Ensure staff is delivering activities
Provide subject matter expertise
Support submission and technical issue resolution
Participate in project teams
Provide input for strategic decisions
Support the execution of initiatives
Drive Operational Excellence
Stay up to date with industry changes
Meet organizational pipeline submission demands
Assist in compilation of departmental metrics
Strive for continuous improvement
Conceptualize new processes
Oversee the implementation and sustained management
and implement innovative technological solutions
Drive operational excellence
Mentor direct reports and team members
Manage direct reports’ performance
How You'll Work.
Team & Collaboration
Partner with Head, Global Submission Management and team; Partner with peers/colleagues; Collaborate with functional partners; Work with product team
Communication Scope
Excellent verbal and written communication skills
Process & Methodology
Apply project management skills to appropriate activities
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