Job title:
Associate Director, Medical Writing
Company:
Alexion Pharmaceuticals
Job description
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.
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.
Expected salary
Location
Dublin
Job date
Sat, 10 May 2025 22:52:55 GMT
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