Location: Barcelona, Spain
Job reference: R-211285
Date posted: 10/21/2024
This is what you will do:
This position is accountable for the timely preparation of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will support the operational and regulatory writing activities across the Alexion portfolio. This position will function with moderate supervision.
You will be responsible for:
- Supporting clinical project teams by authoring high-quality NCCP regulatory documents, including, but not limited to, early-stage protocols, Investigator's Brochures, module 2 summaries for IND/CTA/NDA submissions.
- Managing development of NCCP regulatory documents from first draft to approval. Representing MW cross-functionally, 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, and processes, standard operating procedures and regulatory requirements in partnership with colleagues from statistical, clinical, nonclinical, 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.
- Reviewing, editing, and ensuring production of high-quality documents, or sections of documents, prepared by other writers (internal or contractors), or functional area representatives as required, and ensure adherence to Alexion's MW standards.
You will need to have:
- At least 3 years of regulatory MW experience authoring NCCP documents to support global submissions.
- Demonstrated capability to understand and summarize complex NCCP data and write and manage NCCP regulatory documents.
- 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 timeline negotiation.
- 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; maintain general availability during standard business hours.
We would prefer for you to have:
- Ph D or MS degree in life sciences, preferably pharmacology, 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 with subject matter experts, 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.
Astra Zeneca 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.