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.
Associate Director, Nonclinical and Clinical Regulatory Writing Location: Barcelona, ES
This is what you will do: This position is accountable for the timely preparation of high-quality nonclinical and clinical (NCC) regulatory documents supporting the clinical development portfolio at Alexion. This position will support the operational and regulatory writing activities across the Alexion portfolio. This position will function with limited supervision.
You will be responsible for: Supporting clinical project teams by authoring high-quality NCC regulatory documents in terms of scientific content, strategic organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Managing development of NCC regulatory documents from first draft to approval, representing MW cross-functionally, and negotiating timelines as necessary. Participating with other MW team members to develop and implement processes and standards, and taking responsibility for execution in cross-functional teams. Maintaining adherence to standard operating procedures and regulatory requirements in partnership with colleagues from statistical, clinical, nonclinical, regulatory, quality, and drug safety functions. Developing effective collaborations with other functional lines within Alexion, and keeping abreast of regulatory, industry, and medical writing knowledge and best practices. Reviewing, editing, and ensuring production of high-quality documents, or sections of documents, prepared by other writers (internal or contractors), or functional area representatives as required, and ensuring adherence to Alexion's MW standards. Mentoring as needed less experienced MW team members (internal and external), ensuring high-quality standards and maximal efficiency in the production of NCC regulatory documents. You will need to have: 5-7 years of MW experience authoring NCC documents to support global regulatory submissions. Will consider fewer years of experience if combined with other relevant pharmaceutical industry experience. Demonstrated capability to summarize complex NCC data and write NCC regulatory documents (e.g., Investigator's Brochures, IMPD, 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 timeline 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, preferably pharmacology, or advanced degree in a relevant scientific/clinical/regulatory field. Experience with global clinical studies and regulatory submissions. 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. 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.
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