Senior Manager, Compliance Operations - EMEA
Senior Manager, Compliance Operations - EMEA
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1 Vacancy
Job Description
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo solve problems and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration accountability passion respect and integrity we aim to foster an inclusive diverse and flexible work environment where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Sciences Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day our employees turn their passion for science and research into innovative solutions for patients. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special and our employees July 2024 we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma Best Workplaces in New York PEOPLE Companies That Care Best Workplaces for Women Best Workplaces for Millennials and Best Medium Workplaces lists.
Summary
Responsibilities
- Trainings
- Develop new compliance trainings on identified high risk areas
- Deliver and track compliance trainings
- Maintain the training matrix for compliance trainings in the region
- Identify training needs and develop a risk-based training strategy for the region
- SOP/Process Developments
- Review and update existing SOPs Policies and processes as needed
- Support the development and drafting of new SOPs and/or processes
- Support the Implementation of such new SOPs/processes
- Monitorings
- Support the monitoring efforts in the EMEA region under the guidance of the Senior Director Compliance
- Select and review samples
- Conduct monitorings and complete monitoring checklists
- Prepare monitoring reports
- Conduct field rides and other live monitorings in the countries
- Pull through remediation actions from monitorings
- Maintenance and Enhancements of tools and systems
- Serve as the regional point of contact for the HCP/HCO engagement tool
- Provide help and support on the system and functionalities
- Ensure activity close outs are done timely and complete
- Look for efficiencies and enhancements
- Train/educate the teams
- Maintain the compliance intranet site for the region
- Serve as the regional point of contact for the HCP/HCO engagement tool
- Provide additional operational compliance support as needed
- Support new compliance projects and initiatives (e.g. speak up code of conduct campaigns etc.)
- Prepare risk assessment reports
- Prepare compliance committee material (agenda slide decks etc)
- 4-6 years of experience in the healthcare industry (bio/pharma/med device) and/or in a compliance role
- Profound experience in developing and delivering meaningful and engaging compliance trainings
- Good understanding of the UK ABPI Code and other European Compliance regulations codes and laws
- Experience across the pharmaceutical compliance elements: written standards training effective communication risk assessment auditing monitoring and corrective action.
- Experience in communicating with and influencing mid-level and senior-level management
- Bachelors degree required
- Advanced degree or certification is a plus specifically in training healthcare compliance law or business.
- Excellent written and verbal communication skills and comfort presenting in front of small and large groups
- Highly organized with a strong attention to detail clarity accuracy and conciseness.
- Highly proficient in Microsoft Office (Word Excel PowerPoint Outlook)
- Ability to collaborate and advice management and colleagues on compliance and ethics matters and develop pragmatic business solutions to mitigate risks
- Proficiency in English other languages are a plus
- Flexible and adaptable
- Problem solving skills
- Must successfully exhibit Insmeds five (5) core corporate values of: Collaboration Accountability Passion Respect and Integrity; along with any other position specific competencies.
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
- Up to 20% travel based on requirements
Compensation & Benefits
At Insmed were committed to investing in every team members total well-being now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members regardless of geographic location:
- Flexible approach to how we work
- Competitive compensation package including bonus
- Equity Awards (Long-Term Incentives)
- Employee Stock Purchase Plan (ESPP)
Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability protected veteran status or any other characteristic protected by federal state or local law. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access equal opportunity and reasonable accommodation for individuals with disabilities in employment its services programs and activities. To request reasonable accommodation to participate in the job application or interview process please contact us by email atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Required Experience:
Senior Manager
Employment Type
Full-Time
