Associate Director, Clinical Regulatory Writing

hace 2 días

Barcelona, España AstraZeneca A tiempo completo

The Vaccine & Immune Therapies (V&I) unit has been created with the ambition to develop and deliver vaccines and antibodies that transform our ability to prevent and treat infectious disease. The creation and growth of this unit reflects AstraZeneca’s strong dedication to advance our ground-breaking science for the benefit of patients worldwide.

We are now recruiting an **Associate** **Director, Clinical Regulatory Writing (CReW). **In this role, you will provide strategic leadership and communications expertise to our vaccine and antibody programs. You will author clinical-regulatory documents, provide critical review to achieve high quality standards, and represent the skill on drug and non-drug projects.

**Expectations**:

- Independently lead clinical regulatory writing activities across a sophisticated portfolio of work.
- Author complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and standard methodology are applied.
- As part of a clinical delivery or submission team, provide critical communications to leadership on projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
- When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
- Lead internal/external authoring teams and provide a positive relationship with vendor medical writers to ensure delivery to time and quality.
- Drive the clinical interpretation of complex data and information and condense it into clear, concise, and accurate messages that address customer information requirements.
- Be a problem solver and demonstrate strategic review capabilities.
- Proactively collaborative with other functions at the program level.
- Support the development of Clinical Regulatory Writing Managers.
- Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.

**Minimum Qualifications**:

- At least 3 years of established experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment.
- Understand drug development and communication process from development, launch, and life cycle management.
- Ability to lead large, teams with varied strengths.
- In depth knowledge of the technical and regulatory requirements related to the role.
- Excellent verbal and written communication skills in English.
- Flexibility in adapting to changing circumstances or new information.

This opportunity is available at our Gaithersburg, MD (USA), Boston, MA (USA), Gothenburg (Sweden), Mississauga (Canada), Barcelona (Spain), and Bangalore (India) locations. We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote based working.

**Where can I find out more?

  • Associate Director, Clinical Regulatory Writing

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Role holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications...

  • Director, Clinical Regulatory Writing

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Role holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important...

  • Director, Clinical Regulatory Writing

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. We are now...

  • Senior Director, Clinical Regulatory Writing, Late

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    We are now recruiting a **Senior Director Clinical Regulatory Writing** (CReW) to lead the Late Respiratory and Immunology (Late R&I) CReW teams. The role can be placed in and will report into the Executive Director, Late R&I, respectively. Our Organization follows a hybrid work structure where employees are required to be onsite 3 days a...

  • Director, Clinical Regulatory Writing

    hace 21 horas

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (3 days/week working from the office)** The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best practices. We support...

  • Manager, Clinical Regulatory Writing

    hace 6 días

    Barcelona, España AstraZeneca A tiempo completo

    Location Barcelona onsite - 3 days at office/ 2 days at home. **Typical Accountabilities** Role holders provide communications expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level with occasional contributions to communication strategy development at a program level....

  • Regulatory Affairs Associate

    hace 3 días

    Barcelona, España Inter Regulatory A tiempo completo

    Regulatory Affairs Associate (Medicines) Company: Inter RegulatoryEmployment Type: Full-timeAbout the role Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a Regulatory Affairs Associate (Medicines) to join our consultancy based in Barcelona , primarily working from the Barcelona Health Hub .This role is suited to a...

  • Manager, Clinical and Regulatory Writing

    hace 7 días

    Barcelona, España AstraZeneca A tiempo completo

    **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...

  • Regulatory Affairs Associate

    hace 6 días

    Barcelona, Barcelona, España Inter Regulatory A tiempo completo

    Regulatory Affairs Associate (Medicines)Location:Barcelona, Spain (Hybrid – Barcelona Health Hub)Company:Inter RegulatoryEmployment Type:Full-timeAbout the roleInter Regulatory is expanding its European Regulatory Affairs team and is seeking aRegulatory Affairs Associate (Medicines)to join our consultancy based inBarcelona, primarily working from...

  • Regulatory Affairs Associate

    hace 1 día

    barcelona, España Inter Regulatory A tiempo completo

    Regulatory Affairs Associate (Medicines) Company: Inter Regulatory Employment Type: Full-time About the role Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a Regulatory Affairs Associate (Medicines) to join our consultancy based in Barcelona , primarily working from the Barcelona Health Hub . This role is suited to a...