This position is accountable for the timely delivery of high quality, regulatory-compliant clinical document deliverables for Alexion.
This position will lead the medical writing activities across a disease area or set of clinical programs.
The scope of this position includes the management and oversight of clinical study protocols, Investigator’s Brochures, clinical study reports, and collaborate on smaller scope regulatory submission documents, risk management plans, briefing documents, response documents, pediatric investigational plans, and other IND / CTA or global regulatory submission documents with minimal supervision.
Job Duties & Responsibilities
Develop and implement clinical document strategy for clinical documents, including clinical study protocols, clinical study reports, Investigator’s Brochures and updates, smaller scope regulatory submission documents (includes Module 2 summaries), risk management plans, contributions to briefing documents, response documents, pediatric investigational plans, and other IND / CTA or global regulatory submission documents, working cross-functionally and with minimal supervision.
Manages the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
Actively supports clinical project team(s), representing Medical Writing and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary.
Participates with other medical writing team members to formulate writing strategies and standards to be implemented and takes responsibility for execution.
Develops effective collaborations with other functional lines in Alexion, and externally with regulatory, industry, professional, and academic organizations
Ensures consistent support and implementation of medical writing standards
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.
Partners with Scientific Communications to support clinical trial results, publication activities, and scientific presentation and promotional material for assigned projects
Maintains adherence to uniform processes and stands in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues.
BS degree in life sciences or equivalent required
At least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of medical writing processes and systems across multiple projects
Experience desired in medical writing for ultra-rare diseases and capability to develop and implement innovative solutions for optimizing medical writing for ultra-rare disease studies
Thorough knowledge of global regulatory requirements and ICH / GCP guidelines is essential
Ability to establish excellent internal and external relationships; including alliance partners and vendors
Excellent Project Management and administrative skills
Excellent oral, written, and presentation skills
Excellent problem solving, organizational, and negotiating skills
Experience with adult and pediatric clinical research in various therapeutic areas
Well-developed sense of ethics, responsibility and respect for others
Thrives in a team-based environment
Results-driven and sets standard of excellence for self and others
Fast learner and ability to work independently while seeking advice as required
Demonstrates an entrepreneurial energy and enthusiasm which brings a positive approach to all challenges and fosters the idea that nothing is impossible
High level of flexibility and ability to innovate and adapt to changing conditions
Advanced degree in a relevant scientific / clinical / regulatory field preferred
Experience with global trials and regulatory submissions preferred
Experience with partnering and managing CRO relationships a plus
Experience with ultra-rare disease and Orphan Drug clinical research is highly desirable