Consulting Advisor (m-f-n)
The service is requested as part of the Corporate Compliance Programme Ethics & Compliance HP. The project has the purpose to further development and roll out the Corporate Compliance Programme Ethics & Compliance HP based on the recommendations of internal Audit.
The scope of services includes the following tasks, which are independently performed by the external contractor:
- Further building and implementing the HP Compliance Programme including Audit remediation tasks, more specifically:
o Write, validate and roll out a corporate SOP for Interactions with HP Customers and other Stakeholders in the Corporate Function in Ingelheim; The SOP is to be written due to an earlier identified gap (Internal Audit) in regulations for Corporate HP. The mentioned internal Audit has already been conducted in 2020. The SOP will be approved by the hiring manager prior to its go-live and role out.
The SOP will be written based on the BI template for controlled documents which will be provided to the consultant by the hiring manager and based on the recommendations shared with Ethics & Compliance Human Pharma by Bi's internal audit team after an audit that has been conducted in 2020; delivery February 2021
o Create a training content concept for the corporate SOP Interactions with HP Customers and other Stakeholders based on the predefined needs of the relevant corporate roles. (An overview of those roles will be provided by the hiring manager) Creating the concept will not require the consultant to have any specific digital media knowledge. The content concept will be done in PowerPoint or Word format. This task will be documented by the consultant and is based on the previously mentioned gap analyses as well (Risk Assessment and Internal Audit from Dec. 2020); The training will be reviewed and approved by the hiring manager before go-live; delivery February 2021.
o Update the already existing Compliance Risk Assessment methodology for the Global Therapeutic Areas according to the existing process description provided by BI.
The existing methodology and existing process description will be shared with the consultant by the hiring manager as well as defined by the Internal Audit (Internal Audit already conducted in Dec 2020)The Risk Assessment will be updated according to the global methodology provided by Global Compliance and approved by the hiring manager in the final version
Create a content concept for an internal webpage for Healthcare Compliance topics based on the Audit recommendations. Creating the content concept does not mean that coding or IT knowledge is needed from the consultant. The concept will be technically implemented by a BI employee who knows website building. The consultant will present the draft results to an audience of predefined internal stakeholders (the overview of those will be provided by the hiring manager) and final approval will be provided by the hiring manager; The concept will be done in PowerPoint or World format and delivered to BI after finalization delivery during Q1/2021.
- Based on the global Procedure and more specifically on the corporate SOP on Interactions with HP Customers and other Stakeholders, an approval process for interactions initiated by the Corporate Functions in Ingelheim has been defined. The consultant will evaluate the engagement of Health Care Compliance Professionals and Health Care Compliance organisations from an HP compliance perspective ( strictly based on the above mentioned predefined BI process.) The results of the evaluation will be provided to BI. The final approval of the engagement will be done by the hiring manager; delivery during 2021