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
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
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. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
Alexion Pharmaceuticals, Inc.