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.
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