Global Biopharma client looking for a Legal Counsel to join their team. 12 Month FTC Contract - can be worked remotely from Ireland or EMEA.
We are seeking a motivated and adaptable Lawyer to cover up to 12 months of maternity leave.
The successful candidate must have a commercial outlook, flexible attitude and enjoy working in a fast-paced
international environment. We are a high-performing, team-based organization, where colleagues are
flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation
are key role requirements, as well as organizational skills.
The primary focus of the position will be on serving the legal and compliance needs of the diverse EMEA
business, supporting the EMEA operations across over 60 countries in the region.
The role requires a talented lawyer with superior skills and substantial experience in making sound business
judgments to enable them to support the management of the Compliance Program relating to operations in EMEA which, in collaboration with the Global Compliance & Ethics department, functions
as an independent and objective body that reviews and evaluates compliance issues/concerns within the
Generally, the position supports the Brand and Healthcare Compliance team who along with
the broader EMEA Compliance team, is responsible for ensuring that EUMEA management and
employees are in compliance with the rules and regulations of regulatory agencies, that company policies
and procedures are being followed, and that behavior in the organisation meets the company s Standards
of Conduct, as outlined in the Global Code of Conduct and Business Ethics.
In addition, the Associate Director will support interactions with third parties with whom conducts business in order to
ensure compliance with applicable anti-corruption laws, transparency reporting requirements, and other
external legal/compliance responsibilities are met.
Support in the development, implementation and maintenance of policies and procedures for the
general operation of the Compliance Program and its related activities to prevent illegal, unethical, or
Periodically review and update regional corporate business policies to ensure continuing relevance in
providing guidance to management and employees;
Collaborate with other company functions, including, but not limited to Commercial Operations,
Medical Affairs, Clinical Sciences and Regulatory Affairs to provide advice and counsel regarding
potential compliance issues and risks;
Draft memoranda providing analysis and risk-based recommendations regarding various compliance
rules and regulations implicated by proposed or existing business strategies;
Evaluate, approve, and monitor company interactions with healthcare professionals, healthcare
organisations, patient organisations and other relevant third parties, to ensure they are compliant and
permitted for appropriate business purposes, including organisation of advisory boards, meetings and
Work with the Sales and Marketing teams to review promotional materials for approved products to
ensure, among other things, the pieces are compliant with applicable rules and regulations, are not
misleading in any way and balance risks and benefits associated with treatments;
Review of communications related to the company s development programs to ensure they
accurately and appropriately inform interested parties as to relevant information about the status and
progress of clinical trials;
Support the maintenance of an effective and proactive compliance communication and training
program for the EUMEA region (through Learning Management System and Live trainings), including
promoting use of the compliance hotline and expeditiously and thoroughly fielding questions relating
to new and existing compliance issues and related policies and procedures raised by management
Support global anti-bribery/anti-corruption efforts, including managing the due diligence program
relating to the organisation's partners and distributors;
Manage ongoing maintenance of various healthcare compliance program-related activities and
requirements, including but not limited to review of aggregate spend disclosure reports; activity
reports; monitoring; and investigations.
Manage and collaborate with Global Compliance & Ethics colleagues to ensure EUMEA region
transparency reporting requirements are satisfied;
Assist the Global Compliance and Ethics team in managing the privacy and data protection program
throughout all company functions;
Investigate alleged violations of laws, regulations, company policies and procedures, and/or the
Global Code of Conduct and Business Ethics by evaluating and/or recommending the initiation of
investigative procedures in, collaboration with other internal stakeholder groups (e.g., Human
Resources, Information Technology, etc.);
Assist in developing and overseeing a system for uniform handling of such violations;
Implement corrective action plans for resolution of compliance issues, and provide guidance on how
to avoid or deal with similar situations in the future;
Remain current on external legal and compliance trends in the biopharmaceutical industry to identify
potential areas of compliance vulnerability and risk;
Consult with outside counsel as needed to resolve difficult, complex or particularly sensitive
legal/compliance issues; and
Provide reports on a regular basis, and as directed or requested, to keep Global Compliance &
Ethics, other functions and senior management informed of the operation and progress of the
EUMEA region s compliance effort and tuned in to key regional issues.
Related skills and education requirements
A Bachelor's degree is required; a law degree is required as well as being a qualified lawyer in a EMEA
A minimum 5 years of experience practicing law or working in the pharmaceutical/healthcare
compliance field. In-house experience at a pharmaceutical/biotechnology organisation or regulatory
agency strongly preferred. Major law firm experience is plus.
Experience with and/or understanding of corporate compliance issues confronting the
pharmaceutical, biotechnology, and/or healthcare industry generally.
Demonstrated knowledge and understanding of the legal and regulatory framework affecting the
pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and
abuse issues and other industry guidance documents, EU country regulations on the promotion of
marketed products, clinical trial regulations, and issues arising under the Anti-bribery and Anti-
corruption global law.
Demonstrated effectiveness operating in complex organisational and regulatory environments.
Excellent written and verbal communication and interpersonal skills.
Proven ability to work with all levels of management and the general workforce.
Strong problem solving and risk analysis skills.
Demonstrated ability to partner effectively with others in a matrixed organisation to ensure addressing
Strong persuasive skills and sound business judgment.
Motivated, self-starter with ability to appropriately prioritize issues and allocate resources. Sound
project management skills.
Ability and willingness to travel around the EMEA region.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.