Global Technical Reviewer - Barcelona, España - Astrazeneca Gmbh

Descripción

Location:
Barcelona (on-site) Provide technical accuracy review for promotional and non-promotional global materials. Ensure that these are compliant with AstraZeneca Processes, EFPIA and IFPMA Codes of Practice and other applicable regulations.

Main Accountabilities Provide technical accuracy review of materials (including promotional claims documents) produced by Global Brand teams within the allocated therapeutic area for accuracy and compliance with AstraZeneca global policies and standards, applicable codes, regulatory requirements, and ethical acceptability.

Apply the AZ approach and tone for medical standards within the designated therapy area. Ensure that feedback avoids unnecessary inhibitions to creativity and innovation.

Work with and manage relationships with Global Nominated Signatories and outsourced vendors so that internal colleagues see GNS as one seamless team.

Work with Global Nominated Signatories who undertake final approval according to the local regulatory jurisdiction.

Maintain the highest standards for review of AstraZeneca global materials in line with the EFPIA and IFPMA Codes of Practice, other applicable laws and regulations and policies.

Minimum Requirements

• Education and Experience, Functional & Business knowledge, Specialist Skills Science graduate, medical qualification, or a registered pharmacist.

Experience in the pharmaceutical industry desirable, including medical affairs and/or compliance.
Good scientific understanding of the allocated therapeutic area.
Sound knowledge of international medical compliance legislation, codes of practice and their practical application.
Knowledge and experience of corporate governance are desirable.
Knowledge and understanding of the pharmaceutical industry 'political' environment and of AstraZeneca as an important and leading player.
Experience of successful cross functional working desirable.
Skills and Capabilities High ethical standards. An understanding of ethical decision-making processes and an ability to discuss ethical and regulatory issues with credibility and authority.
Strong interpersonal and leadership skills.
Strong independence and credibility. Proactive and able to work on their own initiative and in a result orientated team environment.
Excellent communication and presentation skills.

Innovative and creative approach to complex problem solving and confidence to make decisions when there is no certain right or wrong answer.

Strong strategic thinking ability.
Strong analytical skills and ability to ascertain the relevant issues from large masses of information.
Consider and manages needs of multiple stakeholders in AZ decision-making and planning.
Ability to work across boundaries to establish common purpose and goals to deliver value.
Demonstrates courage in addressing underlying issues that prevent effective decision-making.

Effectively challenges the business and positions compliance appropriately to influence decisions:
Adopts a solution-oriented approach and focuses on business enablement (ie. achievement of business goals whilst mitigating risks).


Managing compliance risk:
Anticipates future risks and works to innovate by sharing practices with colleagues.

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