Director Medical Writing
Director Medical Writing
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1 Vacancy
Job Description
Director Medical Writing
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
This position is accountable for the timely delivery of highquality 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 minimal supervision.
You will be responsible for:
- Lead development and implementation of document strategy for clinical regulatory submission documents and other clinical documents including clinical study protocols clinical study reports Investigators Brochures and clinical Common Technical Document components (eg Module 2 summaries).
- Contribute to the development of briefing packages responses to health authority inquiries and other IND/CTA or global regulatory submission documents.
- Support clinical project teams by authoring and managing highquality 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.
- Support consistent messaging across all submission documents (nonclinical clinical and product labeling).
- Review to ensure 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.
- Direct and mentor MW team members (internal and external) ensuring quality and efficiency in the production of clinical regulatory documents.
- Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical clinical regulatory quality and drug safety colleagues.
- Develop effective collaborations with other functional lines within Alexion and externally with regulatory industry professional and academic organizations.
You will need to have:
- Excellent oral written and presentation skills; advanced user of MS Office suite.
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
- Demonstrated aptitude for managing the work of external and/or internal medical writers as well as training and fostering development of less experienced staff.
- Welldeveloped sense of ethics responsibility and respect for others.
- The duties of this role are generally conducted in an office environment. As is typical of an officebased 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 nonlinear 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.
- Ability to establish excellent internal and external relationships including alliance partners and vendors.
- Skilled at planning budgeting and project management as well as problem solving organization and negotiation.
- Experience in rare and ultrarare diseases.
- Resultsdriven and with high standards of excellence for self and others.
- High level of flexibility and ability to innovate and adapt to changing conditions.
At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.
Ready to lead and inspire Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.
#LIHybrid
Date Posted
26Mar2025Closing Date
08Apr2025Alexion 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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.
Required Experience:
Director
Employment Type
Full-Time
