To spearhead DSM Biomedical initiatives relating to ethical and legal aspects in the Company’s interactions with health care professionals (HCP ethics). Including establishing policies and procedures, developing and administering related training initiatives, implementing related auditing and monitoring efforts, and performing tasks related to federal and state disclosure requirements.
Functions as the center of expertise in respect to interpretation of laws & regulations pertaining to medical device manufacturer interactions with health care professionals including, but not limited to, recording and reporting payments.
Serve as a resource for the business by providing guidance and answering employee questions about DSM Biomedical policies and procedures concerning interactions with health care professionals, teaching hospitals, etc.
Interacts with BU and COE personnel as an internal consultant to ensure interactions with health care professionals, teaching hospitals, etc. are undertaken in conformance with applicable regulations, policies and procedures.
Works with various functional groups, e.g. finance & legal, to coordinate processes for data collection and reporting.
Work independently or collaborate with functional heads of other departments to implement an effective HCP ethics program.
Works with external entities, e.g. CMS and regulatory advisors, to obtain necessary feedback and guidance to keep abreast of pertinent regulations.
Serves as an objective entity during the performance of investigations of potential violations of policy or procedure.
- Write and maintain policies and procedures concerning interactions with health care professionals, teaching hospitals, etc.
- Plan and perform annual HCP ethics training, new hire orientation sessions, and other training sessions as needed.
- Perform HCP ethics program audits in accordance with the annual audit plan.
- Participate in the investigation of reports HCP ethics program non-compliance as needed.
- Track requirements of state and federal governments, and perform activities related to disclosure reporting in accordance with all applicable laws.
- Track, keep informed, and communicate to Supervisor all changes in government regulations.
- Manage the DSM Biomedical grant and contribution process and serve as administrator/secretary/member of the Grant Review Committee.
- Draft HCP ethics program updates for circulation to employees.
- Assist with the development and implementation of effective internal reporting mechanisms to ensure that DSM Biomedical employees are able to report suggestions or concerns regarding the HCP ethics program.
- Embody the Company’s Vision, Mission and Values.
- Other duties as assigned
Education Level: B.A. or B.S. or 2-4 years equivalent work experience required
Knowledge and experience:
- AdvaMed Code of Ethics
- Sunshine Act
- Experience with and understanding of medical device or pharma HCP ethics programs
- Audit experience
Required level of experiences
- Minimum one year working in a medical device or pharma ethics/compliance function
- Strong interpersonal skills to interact with employees of all organizational levels
- Strong verbal and written communication skills, including the ability to interact effectively with a wide variety of individuals
- Demonstrated ability to work independently and accomplish project goals
The Procedure and Contact
Please apply online and send your resume and cover letter in English and include information on your current remuneration and salary expectations.
Please submit application before deadline: 12/31/2013
DSM - 15 months ago
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