Director, Evidence Generation & Compliance
Director, Evidence Generation & Compliance
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$ 168000 - 312000
1 Vacancy
Job Description
Band
Level 6Job Description Summary
#LI-HybridNovartis has an incredible opportunity for a talented individual to join our team as a Director Evidence Generation & Compliance. You will be responsible for leading the safety and medical compliance function within the US Medical Affairs organization. Be responsible for direct and/or indirect management of people as well as resource and budget management responsibility for their programs. Strategically partners with internal and external stakeholders to provide a center of excellence for Safety Risk Management and Medical Compliance across USMA.
This position is based is East Hanover NJ and will not have the ability to be located remotely. Please note that this role would not provide relocation and only local candidates will be considered. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 25% travel.
Job Description
Key Responsibilities:
- Leads Medical Quality and Compliance within the department.
- May serve as delegate for the ED/Head Evidence Generation Excellence as requested.
- Collaborates and aligns with colleagues on activities pertaining to the annual IRO monitoring and annual ERC monitoring of medical activities and annual risk assessment.
- Collaborates with legal and ERC business partners as business needs dictate.
- Oversees investigations and ensures team is reporting deviations and events including driving corrective action plans.
- Oversee appropriate follow-up and full execution/implementation and deviation management in appropriate system.
- Accountable for audits conducted within the organization.
- Serves as the safety risk expert on project/product teams throughout the product life cycle and contributes to the development and implementation of innovative policies and procedures that will ensure optimized compliance with minimized risk.
- Provides guidance to USMA on Patient Safety processes and requirements.
- Ensures USMA compliance with Pharmacovigilance (PV) Standard Operating Procedures and Working Practices
- Partners with the GDD risk management team and overall Patient Safety organization to work collaboratively towards addressing evolving needs and provide innovative solutions to balance the PV requirements of the Patient Safety organization with the business needs of USMA.
- Strategically partners with Global Patient Safety RA US Medical and Global development and other functions to ensure that Global and US Risk Management strategies are aligned.
- Represent USMA requirements for any Patient Safety system enhancements
- Takes the lead on any Patient Safety related compliance activities (e.g. audits and remediation).
- Partners with medical contracts and Patient Safety organization to resolve questions and requests for changes in template safety reporting language from institutions.
- Serves as the US MAP Medical Governance Lead (MGL) as single point of contact interacting with MAP governance representing US voice suggesting process and system improvements and reporting back to US key messages.
- Collaborates with key MAP stakeholders to ensure process alignment assists in audits metrics and maintains oversight of US MAP program.
- Partners with clinical team and other line functions to ensure successful implementation of MAP programs from onset until product launch
- Serve as the MAP data steward by partnering with the clinical team to ensure system data is accurate and updated in a timely manner
- Ensures cross collaboration with other team members to develop reports and metrics for monitoring medical activities for compliance including development and implementation of risk management plans.
- Oversees monitoring on predefined areas of business risk or ensure business conducts monitoring of its own business activities.
- Proactively identifies potential gaps or risk areas related to quality and compliance regulations guidelines and trends affecting Novartis and supports implementation of improvement initiatives.
- Lead innovative solutions and communications that enhance compliance awareness across the organization.
Essential Requirements:
- Minimum of 7 years in drug development in a major pharmaceutical company including 5 years in safety at anoperational or medical position preferred.
- Experience in clinical trial management drug development regulatory requirements scientific methodology and/or broad understanding of Medical Affairs business functions .
- Clear understanding of GCP regulations and knowledge of international and FDA regulations PhRMA code and other industry guidelines and regulations.
- Strong leadership project management communication presentation and interpersonal skills .
- Proven organizational skills with demonstrated expertise in influencing across a matrix and in managing multiple priorities.
- Ability to communicate effectively manage issues resolve conflicts and mitigate risks
- Experience in preparation of clinical safety assessments and regulatory reports/submissions involving safety information.
Desirable Requirements:
- Experience of REMS/RMPs preferred.
Novartis Compensation Summary:
The salary for this position is expected to range between $168000 and $312000 per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other benefits. In addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Auditing Compliance Risk Corrective Action Plans (Cap) Cross-Functional Teams Drug Development Due Diligence Global Project Management Internal Audit Regulatory Reporting Risk Assessment Risk ManagementRequired Experience:
Director
Employment Type
Full-Time
