This position is accountable for the timely preparation of high quality, regulatory-compliant clinical
document deliverables for Alexion. This position will lead the medical writing (MW) activities across a
disease area or set of clinical programs. This position will function with moderate supervision.
The scope of this position includes the writing, document management, and development support for
clinical study-related documentation including, but not limited to, clinical study protocols, Investigator s
Brochures, and clinical study reports; and to collaborate with cross-functional teams to write and
development regulatory submission documents, risk management plans, briefing books, regulatory
response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission
Authors and manages the completion of clinical documents and other assigned tasks within established timelines with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Clinical document types include clinical study protocols, clinical study reports, Investigator s Brochures and updates, clinical Common Technical components (includes Module 2 summaries), risk management plans, contributions to briefing books, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents.
Supports development and implementation of strategy for writing and completion of high quality clinical documents.
Actively supports clinical project team(s), representing MW, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary.
Participates with other MW team members to develop and support process and standards to be implemented, and takes responsibility for execution across cross functional teams.
Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues.
Develops effective collaborations with other functional lines in Alexion, and externally with regulatory, industry, professional, and academic organizations.
Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards.
Ensures that all activities are conducted in compliance with relevant regulatory requirements.
At least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
Experience with global trials and regulatory submissions preferred
Experience with partnering and managing CRO relationships a plus
Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of MW processes and systems across multiple projects
Experience desired in MW for rare diseases and capability to develop and implement innovative solutions for optimizing MW for rare disease studies
Demonstrated writing capability for clinical study documents, (eg, clinical study protocols and clinical study reports, Investigator s Brochures)
Demonstrated capability to accurately present clinical study data within the context of a specific type of clinical document.
Excellent oral, written, and presentation skills
Thorough knowledge of global regulatory requirements and ICH/GCP guidelines
Ability to establish excellent internal and external relationships, including alliance partners and vendors
Excellent project management skills, with emphasis on time management and timelines, and
Excellent problem solving, organizational, and negotiating skills
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 or independently, seeking advice as required.
Results- and compliance-driven; sets standard of excellence for self and others
High level of flexibility and ability to innovate and adapt to changing conditions
MS degree in life sciences or equivalent required; advanced degree in a relevant