Manager, Clinical and Regulatory Writing
hace 2 días
**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**:
The Clinical Regulatory Writing Manager is expected to:
- 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.
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