北京招聘

500强医药公司

合规专员Health Care Compliance

POSITION – HCC RIBD Specialist – AsPac (regional) and PMO (global) – Contract Position

MAIN ROLES:

PART 1:  RIBD Asia Pacific

1)      HCC RIBD AP Monitoring & Internal Controls  

-          Responsible for supporting the RIBD AP HCC Team,  to execute testing and monitoring plans for HCC RIBD, working closely with GACS and DSRM.

-          Lead and supervise the following activities: 

·         Implement annual Monitoring Plan.

·         Conduct of related training, as needed.

·         Preparation of written reports summarizing observations and recommendations that will be presented to business stakeholders.

·         Providing consultation regarding process efficiency and corrective action effectiveness. 

·         Developing new and updated testing, audit and monitoring protocols and procedures for selected focus areas in partnership with legal, finance and compliance stakeholders. 

-   Shape the internal and external environment by leading or participating on other assigned special project teams or industry working groups related to auditing and monitoring and TPI management.

2)      GOEX AP Support and System Administration

·         Own and manage GOEX application, Functional System Admin for all Research, Innovation, and Business Development (RIBD) in ASPAC

·         Provide transactional/day-to-day support.

·         Monitor for any issues (e.g. duplicate transactions or vendor adds, etc.). Take corrective action to fix identified issues.

·         Analytical support for business initiatives for significant process improvement projects.

·         Provide technical support and resolve end user issues; escalating as needed.

·         Create and maintain training materials and conduct new user and ad hoc trainings

·         Maintenance of GOEX records.

·         Maintain user’s database by adding, removing or updating access.

·         Coordinate alignment of changes/feedback on the system

·         Conduct TPI reputation check & FMV validation for GEI projects, as required to complete the HCC approval process

3)      Data Management support for RIBD AP

§  Training Records

§  Deviation Records

§  Exception Records

·         Transactional Records

·         Communication Blueprint reports

·         Dashboard reports

·         MAP reports

4)      SharePoint site/portal development and maintenance for RIBD AP

PART 2:  Global RIBD Support for Seven Elements Activities

A)     RIBD Training Strategy

o   responsible for supporting the planning and deployment of 2021 RIBD Training strategy, working closely with GPTC, PMO, HCC LT sponsor and functional area leads (Pharm/MD R&D, GEI).

o   Tasks and responsibilities as main contact point for RIBD and GPTC include:

o   Lead deployment of the HCC Annual Training in RIBD

o   Customize Training communication resources from global

o   Target audience identification for functional area specific training (mini-modules) based on business rules, in coordination with functional area leads;

o   Submission of training deployment plan to Summit

o   Level 2 support for issues resolution beyond Summit

o   Develop RIBD completion reports, as required by RIBD LT

o   Report back to RIBD LT, as needed.

B)      Policy/Communications/Governance

a.       Management of RIBD policies in TruVault.

b.      Coordinate the identification, tracking and updating of RIBD guidance resources.

c.       Review and provide recommendations for aligning Communication Blueprint items across RIBD.

d.      Prepare reports from Communication Blueprint including Compliance Committee status and RIBD future and completed communication items.

C)      Risk Assessment Data Collation / Risk Review

a.       Pull data reports across the risk data elements (monitoring, MAPs, Unplanned Deviations, Exceptions, SIs, audits, etc. for risk reviews; collate data for presentation.

b.      Gather Annual Risk Assessment output files, prepare for presentation.

D)     Highbond Monitoring Super User

o   Manage Monitoring plans in Highbond, including annual plan entry and updates under direction from HCCOs.

Some of the key competencies crucial for success in this role include the following: Critical thinking and problem solving skills, Planning and organizing, Decision-making, Communication skills, Influencing and leading, Delegation, Team work, Negotiation, Conflict management, Adaptability, and Stress tolerance.

Qualifications:

?       A minimum of a Bachelor’s Degree with +3 years is required.

?       Experience in the pharmaceutical and/or medical device industries is highly desired. 

?             Direct experience implementing monitoring programs is preferred. Direct experience is required conducting audits, developing and managing auditing programs in one or more of the following compliance areas: HCC, FCPA, Finance or Quality. 

?             Working knowledge of HCC/fraud and abuse laws; regulatory promotional practices; FCPA or financial auditing practices, including system solutions, is required. 

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