Associate Director, Medical Writing
Associate Director, Medical Writing
Reports to: Sr. Director, Medical Writing
Location: Zurich, Switzerland
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. Alexion is also establishing a premier global metabolic rare disease franchise, which includes Kanuma™ (sebelipase alfa) for patients with lysosomal acid lipase deficiency (LAL-D), and Strensiq™ (asfotase alfa) for patients with hypophosphatasia (HPP). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. As the global leader in complement inhibition, the Company is strengthening and broadening its portfolio of complement inhibitors across diverse platforms, including evaluating potential indications for Soliris in additional severe and ultra-rare disorders. Further information about Alexion can be found at: www.alexion.com.
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.
- 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.
- 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 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
- BS degree in life sciences or equivalent required; advanced degree in a relevant scientific/clinical/regulatory field preferred
- 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
- Experience with ultra-rare disease and Orphan Drug clinical research is highly desirable
- 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
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. To learn more about Alexion, please visitwww.alexionpharma.comor download our App for iPhones and Blackberries.