Compliance and Legal Specialist

Compliance and legal specialist for well-known pharmaceutical company.

Major objectives of the role:

Active participation in development and implementation of a compliance program to ensure the company operates in accordance with all laws and regulations.

Serve as the first point of contact for compliance matters, ensuring business practices are complaint with applicable legislation and internal guidelines. Maintaining of a compliance culture within the organization as part of the task to support effective business processes.

Provide legal support for various functions (HCO/HCP engagement, Partners check Process management, Contracts legal check support).

Report: directly to Compliance officer (Financial Director).

Responsibilities:

Compliance

Assistance in the harmonization, preparation, updating and implementation of policies and procedures. Support in implementation of global compliance programs.

Reviews of activities where collaboration with health care professionals is required, detection of gaps in the processes in order to further develop them (e.g. revision of SOPs, training and communication, limits of hospitality). Review and monitor document flow related to events organization with HCPs. Advice re. cooperation with HCPs in transparent manner according to AIPM Code of Practice.

Perform compliance monitoring to determine whether established policies are being followed and where they can be improved (routine compliance check).

Raise awareness and engagement of employees on compliance topics withing the company. Development and conducting Inductions / Trainings for the employees and relevant stakeholders on Health Care and general Compliance requirements. Creating training materials. Provide of advice to the employees in the field of compliance and ethics.

Participate and drive the projects on implementation of legal & compliance topics: Personal Data protection, Changes in Law on Advertisement, anti-corruption law.

Develop the compliance communication plan of activities.

Participation in regular compliance committees.

Preparing of the reports on Transfer of Values to HCPs (according to AIPM standards).

Monitoring any changes of AIPM ethic and compliance principles (AIPM code of Practice).

Support for tasks / projects delegated by Compliance Officer.

Internal Audit support (when needed).

Legal support:

Due diligence of partners.

Participate in drafting of contracts and legal check support.

Assistance in preparation of various legal documents (PoAs, protocols, regulations, Memos).

Prepare protocols of compliance committees.

Close collaboration with external lawyers.

PROFILE:

Legal degree / background / experience in compliance / health care compliance not less than 1-2 years.

English – upper intermediate or fluent

Demonstrate endeavor and ability to learn and grow, contribute to personal development.

Eager to identify areas of simplification/optimization proposing solutions to enable business acting fast without losing in safety of business operations.
Ability to communicate information to colleagues in a clear and transparent manner.