Associate Director, Clinical Regulatory Writing

Are you passionate about transforming science into clear and compelling regulatory documents that drive successful drug development? We are seeking a talented and experienced Associate Director, Clinical Regulatory Writing to join our CVRM (Cardiovascular, Renal and Metabolism) Clinical Regulatory Writing team in Gothenburg, Sweden. With more than 2,400 employees from over 50 countries, our vibrant Gothenburg site is a truly inspiring place to work - where the history and future of scientific breakthroughs come together. We believe that the diversity of our people is crucial to bringing new discoveries to life.

Accountabilities:

The CVRM Clinical Regulatory Writing group provides expert strategic leadership and communications expertise to clinical drug programs, ensuring delivery of high-quality, label-focused documents aligned with project strategy, regulatory requirements, and communications best practices. Role holders not only author critical clinical-regulatory documents but also act as critical reviewers to achieve the highest quality standards. Team members also represent the Clinical Regulatory Writing skill set on both drug and non-drug projects, advocating for best practices and continuous improvement.

Key Responsibilities

As an Associate Director, Clinical Regulatory Writing, you will:

Provide strategic leadership and communication expertise to clinical drug programs across the CVRM portfolio.

Author and critically review clinical-regulatory documents, ensuring the highest regulatory, technical, and quality standards.

Represent Clinical Regulatory Writing on project teams, advocating for communication best practices.

Provide strategic communications leadership within clinical delivery or submission teams, establishing standards and promoting quality and efficiency.

Act as NDA/MAA submission lead, driving the development of the clinical Submission Communication Strategy (cSCS) and successful submission delivery.

Lead both internal and external authoring teams and cultivate strong partnerships with vendor medical writers to ensure timely, high-quality document delivery.

Translate complex clinical data into clear, concise, and accurate messages tailored to specific audiences.

Support the development and upskilling of colleagues within the Clinical Regulatory Writing function.

Champion continuous improvement and operational excellence in communications.

Essential Skills/Experience:

Bachelor's degree in Life Sciences or a related discipline.

Significant medical writing experience within the pharmaceutical industry or a Contract Research Organization (CRO).

Proven ability to advise and lead communications projects and teams.

Strong understanding of drug development and the communications process from early development through to launch and lifecycle management.

In-depth knowledge of technical and regulatory requirements relevant to clinical regulatory writing.

Desirable Skills/Experience:

Advanced degree in scientific discipline (e.g., Ph.D.).

If you are driven to deliver impactful regulatory communications, excel in multidisciplinary teams, and want to shape the future of clinical development, we encourage you to apply.

Apply with your CV and cover letter by 30 August!