Independently writes clinical protocols, reports, and
investigator brochures and mentors junior writers. The Sr. Medical
Writer will collaborate with other writers, other departments, and
medical writing vendors to ensure quality and consistency of
clinical documents submitted to regulatory agencies.
Collaborates with Biostatistics, Clinical Operations, Clinical
Science, Translational Medicine, Regulatory Affairs, and other
departments on the development and/or revision of protocols,
protocol amendments, clinical study reports, clinical sections of
regulatory submission documents, investigator’s brochures,
presentation material, etc. Writes CTD Module 2 summary documents
and Module 5 integrated summaries
Manages all aspects of the medical writing processes for
document development including quality control, scheduling/timeline
management, driving document preparation, coordinating document
reviews and revisions, maintaining version control, and
coordinating final reviews and approval
Researches and collects source documentation (eg, literature
searches, project files). Helps maintain database of literature
Participates in reviewing, editing, and creating SOPs, job aids,
and templates. Acts as recognized technical resource for peers.
Improves operational procedures for the Medical Writing group and
Attends regular project meetings, identifies project tasks, and
with the Sr. Director of Medical Writing, formulates strategy for
completion. Plays an educational role on cross-functional project
teams, advocating for better understanding and appreciation of
Medical Writing’s place in clinical development
Acts as an internal and external liaison for Medical Writing.
Plays an active role in negotiating timelines for primary projects.
Provides guidance and expertise to work teams regarding all aspects
of clinical writing, including the correct usage of templates as
well as the content of regulatory guidances on documents
Routinely contributes to the training and development of
less-experienced peers. Coaches less-experienced team members in
problem solving. Provides constructive input for performance
Supervises and reviews the work of more junior medical writers,
as well as contract medical writers
Minimum Education & Experience Requirements
BS in medical or life sciences or related area, plus a minimum
of 3 years of writing experience in a clinical development or other
scientific environment, OR
M.Sc./MPH, and 2 years of experience as a medical writer OR
Ph.D. in life sciences, and 18 months of experience as a medical
Good understanding of experimental design and ethical principles
in human clinical trials
Proficiency in clinical writing, including protocols, study
reports, and investigator brochures. Familiarity with the writing
of CTD summary documents. Good understanding of clinical research
documentation, ICH guidelines, and GCP.
Must be very skilled in written and oral communication.
Intermediate-to-advanced negotiation skills required, to allow
effective collaboration with other disciplines on complex projects.
Exemplary proficiency in presentation skills needed.
Good understanding of the work of other clinical functional
areas. Sufficient understanding of biostatistics to correctly
interpret and describe results in clinical reports and other
Demonstrated proficiency in Microsoft Office software and
advanced proficiency in MS Word. Skilled in using and developing
document templates. Proficiency using EndNote software.
Capacity to provide thoughtful coaching of junior writers
Alkermes, Inc. is an equal employment opportunity employer and
does not discriminate against any applicant because of race, color,
religion, sex, sexual orientation, gender expression and identity,
national origin, ancestry, age, mental and physical disability,
genetic information, any veteran status, military status or
application for military service, or membership in any other
category protected under applicable law.