Senior Governance, Risk and Compliance Analyst, Customer Assurance
Wiz
AWSAzureCloudGoogle Cloud Platform
Medical Manager
Sanofi
full-time
Posted on:
Location Type: Office
Location: Reading • 🇬🇧 United Kingdom
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Act as Subject Matter Expert (SME) for conduct of all scientific/clinical research within Specialty Care Medical Department in compliance with company SOPs
- Project manage externally sponsored studies (ESR) to meet local business, regulatory, safety and ethical requirements
- Project manage company-sponsored studies (CSS) to meet local business, regulatory, safety and ethical requirements
- Provide strategic input to relevant processes and support Head of Medical Operations, Compliance and Governance
- Support Risk Minimisation Materials (RMM) oversight and Managed Access Programmes management as required
- Lead ISS execution: review and approve proposals locally, draft and negotiate contracts (with Legal), undertake due diligence and fair market value processes
- Manage investigational medicinal product processes including forecasting, receipt and issue resolution
- Ensure regular status updates with Medical personnel in each Franchise and ensure publications are compliantly reviewed
- Train Medical staff in the ESR process and use of the ESR portal; provide input to local process changes and archiving of documentation
- Assist with procurement of vendors, advise on ethics and health authority approvals, and improve study setup metrics and timelines
- Prepare and submit annual Transfer of Value reporting for all evidence generation activities
- Assist in audits and inspections and provide strategic responses where appropriate
- Undertake any other tasks including Managed Access as required for the Medical Manager function
Requirements
- Educated to degree level or higher level scientific qualification or equivalent
- Proven project management capability
- Strong organisation skills, ability to prioritise own workload and deal with changing priorities
- Experience/knowledge of clinical trial design, management, analysis and reporting, including GCP principles
- Knowledge of Regulatory guidelines, Medicines Act and the Human Medicines Regulations, ABPI/IPHA Code of Practice and Standard Operating Procedures, and experience of their implementation within the business environment
- Thorough knowledge of relevant GxP, company procedures, therapy areas and products
- Preferred knowledge of Specialty Care products and related therapeutic areas
- Knowledge of the structure of the NHS
- Communication skills, written, verbal & non-verbal ability to communicate at all levels
- A team player with a flexible approach, able to collaborate and build cross-functional relationships
- Ability to learn quickly in a fast-paced environment
Benefits
- Thoughtful, well-crafted rewards package
- High-quality healthcare, prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
- Opportunities for promotion, lateral moves and international mobility
- Supportive, future-focused team and inclusive workplace
- Adjustments for interview process for disability (inclusive hiring practices)
- Visas for those who do not already have the right to work in the UK will be considered on a case by case basis
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementclinical trial designclinical trial managementclinical trial analysisclinical trial reportingGCP principlesRegulatory guidelinesGxPSOPsTransfer of Value reporting
Soft skills
strong organisation skillsability to prioritise workloadcommunication skillsteam playerflexible approachcollaborationability to learn quickly
