Associate Director, Medical Writing

Alexion Pharmaceuticals, Inc. Boston , MA 02298

Posted 1 week ago

Position Summary

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.

Essential Qualifications

  • 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

Preferred Qualifications

  • 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

  • LI-MW1

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Medical Writing

Vertex Pharmaceuticals, Inc

Posted 9 months ago

VIEW JOBS 4/13/2019 12:00:00 AM 2019-07-12T00:00 Job Description The Associate Director manages the overall operations of a team or major project and implements this through effective leadership. The Associate Director provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. The Associate Director applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing department activities with those of other departments. This will be a full time role located in Boston, MA. Key Responsibilities: * Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objectives * Identify new technologies and initiatives related to the preparation of clinical documents, provide well-informed recommendations, and facilitate integration into department processes * Proactively anticipate risks, solve complex problems, and seek out and implement process improvements * Provide input to strategies and tactics for the Medical Writing department * Provide coaching and performance management #LI-SO1 Minimum Qualifications * PhD (or equivalent degree) and 5+ years of relevant work experience Vertex Pharmaceuticals, Inc Boston MA

Associate Director, Medical Writing

Alexion Pharmaceuticals, Inc.