This is what you will do:
This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will support the medical writing (MW) activities for one or more clinical programs. This position will function with moderate supervision.
You will be responsible for:
* Supporting clinical project teams by authoring and managing the development and completion of high-quality clinical regulatory documents including, but not limited to, clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (eg, Module 2 summaries).
* Ensuring strategic organization, clarity, accuracy, format, and consistency of scientific content.
* Representing MW cross-functionally and with external vendors, negotiating timelines as necessary.
* Participating with other MW team members to develop and implement process and standards, and take responsibility for execution in cross-functional teams.
* Maintaining adherence to internal guidelines, styles, processes, standard operating procedures, and regulatory requirements in partnership with colleagues from statistical, clinical, regulatory, quality, and patient safety functions.
* Developing effective collaborations with other functional lines within Alexion, and keeping abreast of regulatory, industry, and medical writing knowledge and best practices.
You will need to have:
* 3-5 years of regulatory writing experience; will consider fewer years of writing experience combined with other relevant experience.
* Demonstrated capability to understand and summarize complex clinical data, and write and manage clinical study documents (eg, clinical study protocols, clinical study reports, and Investigator's Brochures).
* Knowledge of global regulatory requirements and ICH/GCP guidelines.
* Excellent oral, written, and presentation skills; advanced user of MS Office suite.
* Results- and compliance-driven; sets standard of excellence for self and 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; and maintain general availability during standard business hours.
We would prefer for you to have:
* MS or PhD degree in a relevant scientific/clinical/regulatory field.
* 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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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