Manager, Clinical and Regulatory Writing

AstraZeneca; Barcelona; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Barcelona is seeking a Manager in Clinical and Regulatory Writing. This role requires fluency in English and focuses on producing high-quality clinical-regulatory documents essential for successful submissions and approvals. Key qualifications include a Life Sciences degree, medical communications experience, and strong leadership skills. This position offers a unique opportunity to impact patient lives and work within a collaborative environment.

Servicios

Diversity and equality of opportunity

Inclusive and collaborative work environment

Formación

• Education: Life Sciences degree in an appropriate discipline.
• Experience in medical communications required.
• Strong communication and leadership skills needed.
• Knowledge of technical and regulatory requirements related to the role.

Responsabilidades

• Lead and deliver timely high-quality clinical-regulatory documents.
• Ensure compliance with regulatory, technical, and quality standards.
• Drive clear communications for customer requirements.
• Collaborate effectively with other functions and external providers.

Conocimientos

Fluency in English

Strong communication skills

Leadership skills

Knowledge of technical and regulatory requirements

Educación

Life Sciences degree

Advanced degree (Ph.D.)

Descripción del empleo

Introduction to role

This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.

Are you ready to lead the charge in transforming breakthrough science into life-altering solutions? As a Manager in Clinical and Regulatory Writing, you'll be at the forefront of driving strategic communication excellence. Our team is dedicated to crafting high-quality clinical-regulatory documents that align with project strategies and regulatory requirements. We support core therapeutic areas throughout all phases of clinical development, aiming for successful submissions and approvals. Join us in making a tangible impact on patient lives!

Accountabilities

• With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents.
• Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
• Balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.
• Drive the clinical interpretation of data and information and condense it into clear, concise, and accurate messages that address customer information requirements.
• Provide critical review of documents for correctness, clarity, completeness, and compliance.
• Proactively collaborate with other functions during document development, including, as needed, with external service providers/contractors.
• As part of a clinical delivery team, provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required.
• Work independently but with the guidance and support of more senior members of the group.

Essential Skills/Experience

• Education: Life Sciences degree in an appropriate discipline.
• Experience in medical communications.
• Strong communication and leadership skills.
• Knowledge of the technical and regulatory requirements related to the role.

Desirable Skills/Experience

• Education: Advanced degree in a scientific discipline (Ph.D).
• Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by science and success. Our rich pipeline offers exposure to groundbreaking medicines across diverse therapy areas at all stages of development. We thrive in an inclusive environment where collaboration fuels innovation. By embracing change and taking smart risks, we deliver rapid global approvals that transform science into real value for patients. Here, you have the autonomy to be an agent of change while benefiting from global opportunities to develop in multiple roles.

Ready to make a difference? Apply now and be part of our journey to bring life-changing medicines to patients worldwide!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.