Director, Medical Writing

This is what you will do:

This position is accountable for the timely delivery 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 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, Investigator's 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 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.
• 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.
• Well-developed 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 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.
• 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 ultra-rare diseases.
• Results-driven and with high standards of excellence for self and others.
• High level of flexibility and ability to innovate and adapt to changing conditions.

Date Posted

Closing Date