Associate Director, Medical Writing

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 

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, Investigator's 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, Investigator's 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. 

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. 

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