Spain Job Openings
Alexion Pharmaceuticals,Inc.
Director, Nonclinical and Clinical Pharmacology Writing
Barcelona
October 21, 2024
This position is accountable for the timely delivery of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the NCCP writing activities across a disease area or set of clinical development programs. This position will function with limited supervision.
You will be responsible for:
- Lead development and implementation of document strategy for NCCP regulatory documents, including, but not limited to, early-stage protocols, Investigator’s Brochures, module 2 summaries for IND/CTA/NDA submissions.
- Contribute to the development of briefing packages, responses to health authority inquiries, and other IND/CTA or global regulatory submission documents.
- Author and manage high-quality NCCP MW 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. May function as submission and/or program lead.
- Review to 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 MW team members (internal and external), ensuring quality and efficiency in the production of NCCP regulatory documents.
- Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, quality, and safety colleagues.
- At least 10 years of regulatory MW experience authoring and leading global regulatory submissions.
- Demonstrated capability to summarize complex data and write regulatory documents.
- Excellent oral, written, and presentation skills; advanced user of MS Office suite.
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
- Demonstrated aptitude for managing the work of external and/or internal medical writers, as well as training and fostering development of less experienced staff.
- Well-developed sense of ethics, responsibility, and respect for 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.
- Ph D or MS degree in life sciences or advanced degree in a relevant field.
- Broad experience with global clinical studies and regulatory submissions.
- Ability to establish excellent internal and external relationships with subject matter experts, alliance partners, and vendors.
- Skilled at planning, budgeting, and project management, as well as problem solving, organization, and negotiation.
- Experience in rare and ultra-rare diseases.
- Results-driven and with high standards of excellence for self and others.
- High level of flexibility and ability to innovate and adapt to changing conditions.
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