Position SummaryThis 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
- administrative skills
- 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
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.