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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 leading timely development of high quality, regulatory-compliant clinical document deliverables spanning the product life cycle across multiple clinical programs and disease indications. The scope of this position includes the management of both internal and external resources, performing medical writing duties as needed, and contribute senior level industry experience to support strategic development of complex analytical documents for regulatory submissions.

You will be responsible for:

• Delivery of clinical medical writing deliverables and objectives across multiple programs and indications to quality, time, and budget.
• Work in close collaboration with Global Program Teams and their leaders to ensure alignment with program objectives.
• Lead, supervise, and manage performance of the global internal medical writing team across sites including development and succession planning.
• Develop strategies and manage execution of external support for the internal team with Contract Research Organizations (CRO), or other external resources including in various locations globally.
• Develop and manage program level medical writing resource plans and budgets.
• Drive operational excellence for medical writing standards, processes, systems and tools.
• Actively foster a can-do attitude to drive exceptional performance and continuous improvement.
• Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice with respect to reporting activities.
• Safeguard consistent support and implementation of medical writing standards and stand in partnership with statistical, clinical, regulatory, pharmacovigilance, and quality operations colleagues.
• Develop effective collaborations with other functional lines within Alexion, and keep abreast of regulatory, industry and medical writing knowledge and best practices.

You will need to have:

• 10+ years of clinical research experience or regulatory equivalent, with 5+ years of experience in the development & management of a medical writing function and direct management of staff in a pharmaceutical and/or biotechnology environment.
• Demonstrated experience with writing and leading deliverables for global clinical trials and regulatory submissions.
• Experience with direct management of staff in a pharmaceutical and/or biotechnology environment.
• Experience partnering and managing CRO relationships and other external resources a plus.
• Proven excellence in operational strategy and demonstrated ability to execute operationally.
• Excellent communication, planning and organizational skills.
• Ability to inspire, to lead-by-example and motivate the team to seek solutions and get results.
• 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:

• Masters or Doctoral degree or equivalent in a medical/scientific discipline.
• Experience in rare diseases
• Ability to establish excellent internal and external relationships with subject matter experts, 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.