Associate Director, Medical Writing

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:

• Author and manage the completion of clinical documents including clinical study protocols and amendments, clinical study reports, Investigators Brochures and updates, and clinical Common Technical Document components (eg, Module 2 summaries). Contribute to the development of briefing packages, responses to health authority inqueries, pediatric investigational plans, 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 development and implementation of strategy for writing and completion of high-quality clinical documents.
• Participate with other MW team members to develop and implement process and standards and take responsibility for execution in cross-functional teams.
• 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.
• Review, edit, and 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.
• Mentor less experienced MW team members (internal and external), ensuring quality and efficiency in the production of clinical regulatory documents.

You will need to have:

• Clinical regulatory MW experience, including global clinical studies and regulatory submissions. Will consider less MW experience combined with other relevant pharmaceutical industry experience.
• Demonstrated capability to write clinical study documents (eg, clinical study protocols, clinical study reports, Investigators 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.

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.