Senior Manager, Nonclinical and Clinical Pharmacology Writing

Location: Barcelona, Spain (Hybrid Model)

This role requires working from the office 03 days per week.

This position is responsible for the timely preparation of high-quality, regulatory-compliant nonclinical and clinical documents in support of the clinical development portfolio at the Alexion Rare Disease Unit (Alexion). The role supports medical writing activities across multiple therapeutic areas, modalities, and disease indications for early-stage clinical programs, and contributes to late-stage programs through the authoring of nonclinical and clinical pharmacology regulatory documents. The position operates with moderate supervision.

In support of Alexion’s mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team leads the development of strategic, high-quality, and compliant documents to enable clinical research and regulatory approval of new therapies, while ensuring ongoing compliance with applicable laws, policies, regulations, and public commitments related to transparency and disclosure.

The Alexion Medical Writing team provides expert leadership and strategic authorship of clinical and nonclinical regulatory documents and supports Alexion’s core therapeutic areas across all phases of clinical development.

Responsabilities:

• Support clinical program teams by authoring and managing the development and completion of high-quality clinical regulatory documents including, but not limited to, early-stage clinical study protocols and amendments, clinical study reports, Investigator’s Brochures, and other IND/CTA or global regulatory submission documents.

• Author documents, ensuring that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practices are applied.

• Balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.

• Ensure strategic organization, clarity, accuracy, format, and consistency of scientific content.

• Proactively collaborate with other functions including, as needed, with external service providers/contractors.

• Develop effective collaborations with other functional lines within Alexion, and keep abreast of regulatory, industry, and MW knowledge and best practice.

• Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Alexion MW.

• Work independently but with the guidance and support of more senior members of the group.

• This is an individual contributor position with no direct reports.

Essential Skills/Requeriments:

• Education or experience in science, preferably pharmacology (PhD not required, but preferred)

• Academic foundation in science, preferably pharmacology

• Strong understanding of pharmacology data sets, able to quickly analyze and summarize for submission documents.

• Experience in regulatory documentation and/or medical communications.

• Medical Writing experience in the pharmaceutical industry.

• Excellent oral, written, and presentation skills.

• Knowledge of the technical and regulatory requirements related to the role.

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's Alexion division, you'll find a place where innovation meets purpose. Our commitment to rare diseases means your work directly impacts lives. With a rapidly expanding portfolio and an entrepreneurial spirit akin to a leading biotech, you'll thrive in a culture that values connection and exploration. Supported by exceptional leaders and peers, you'll be empowered to grow your career while making a difference where it truly counts.

Ready to make an impact? Apply now to join our team!

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.