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Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

This position is accountable for the timely preparation of high-quality clinical regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with limited supervision as required.

You will be responsible for:

• Authoring and managing the completion of clinical documents including clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (eg, Module 2 summaries). Contribute to the development of briefing packages, responses to health authority inquiries, pediatric investigational plans, and other IND/CTA or global regulatory submission documents.
• Supporting clinical project teams by authoring and managing high-quality MW deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Represent MW cross-functionally, negotiating timelines as necessary.
• Supporting development and implementation of strategy for writing and completion of high-quality clinical documents.
• Participating with other MW team members to develop and implement process and standards and take responsibility for execution in cross-functional teams.
• Maintaining adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues.
• Developing effective collaborations with other functional lines within Alexion, and externally with regulatory, industry, professional, and academic organizations.
• Reviewing, editing, and ensuring quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
• Mentoring less experienced MW team members (internal and external), ensuring quality and efficiency in the production of clinical regulatory documents.

You will need to have:

• At least 5-7 years of clinical regulatory MW experience, including global clinical studies and regulatory submissions. Will consider fewer years of MW experience combined with other relevant pharmaceutical industry experience.
• Demonstrated capability to write clinical study documents (eg, clinical study protocols, clinical study reports, Investigator's Brochures, and Module 2 summaries).
• Excellent oral, written, and presentation skills; advanced user of MS Office suite.
• Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
• Skilled at project management, with emphasis on time management, organization, and negotiation.
• Results- and compliance-driven; sets standard of excellence for self and others.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• PhD or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field.
• Experience with global clinical studies and regulatory submissions.
• Ability to establish excellent internal and external relationships, including alliance partners and vendors.
• Team player who thrives in a team-based environment.
• Well-developed sense of ethics, responsibility, and respect for others.
• Agile learner with ability to work both collaboratively and independently, seeking advice as required.
• High level of flexibility and ability to innovate and adapt to changing conditions.

#LI-Hybrid

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

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 [email protected]. Alexion participates in E-Verify.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.