Principal Medical Writer
Company: Arrowhead Pharmaceuticals
Location: Pasadena
Posted on: March 20, 2023
Job Description:
Compensation DescriptionThe base salary range for this position
in the selected city is $140,000 - $200,000 annually.The
PositionThe Principal Medical Writer collaborates with members of
cross-functional teams to prepare high-quality regulatory and
clinical documentation for submission to global regulatory agencies
including the preparation of components for INDs/NDAs, annual
reports, Orphan Drug Designation applications, and briefing books
as well as clinical study documentation such as protocols,
investigator brochures, etc. as required within agreed-upon
timelines. The Principal Medical Writer also assists with the
preparation of publications, abstracts, and other external
communications in support of Arrowhead business functions. The
Principal Medical Writer also assists in implementing processes and
standards to ensure company scientific documents are prepared to
the highest editorial standards and quality.Responsibilities
Prepares, edits, and finalizes
protocols, investigator brochures, synopses, clinical study
reports, regulatory documents (INDs/NDAs, annual reports, Orphan
Drug Designation applications, Agency Response to Questions,
briefing books, pediatric study plans, etc)Prepares related
clinical documents, such as abstracts, posters, presentations, and
manuscriptsCollaborates with and manages contract medical writers
as required for project assignmentsAdvises and assists in the
review and management of nonclinical and CMC technical reports as
requiredManages the document development and review process;
schedules and conducts document-related meetings including kickoff
meetings and document review discussions -Collaborates with program
managers and teams to develop and maintain document timelines and
ensure milestones are achievedEnsures conflicting and ambiguous
document comments are clarified and appropriately addressedDevelops
and maintains company house-standard templates and best review
practices for regulatory and clinical documentation. Ensure vendors
and contractors maintain company standardsParticipates in
regulatory and clinical team strategy meetings to ensure that
results and messages in clinical documents accurately reflect the
data in tables, figures, and listings (TFLs) and other information
sources. Partners with the scientific staff including participation
in the review of mock and/or blinded TFLs, and narrative planning
for relevant documentsAssists in the development and maintenance of
Development Core Product Data Sheets, draft labeling, and company
work instructions and SOPs, as requestedEnsures that medical
writing deliverables conform to International Conference on
Harmonisation (ICH) and other relevant regulatory guidelines and
medical editorial boardsEnsures documents are generated in
accordance with agreed internal processes and standards, are
submission ready, and are appropriately stored in appropriate
document management system(s)Ensures that appropriate documented
quality control and data verification checks are performed on
regulatory/medical writing deliverables, responds to findings, and
recommends quality process improvementsRequirements:
Bachelor's degree in a medically
related field or life scienceA minimum of 6 to 8 years of relevant
medical writing experience in the pharmaceutical industry is
essentialMembership in professional medical writing, regulatory, or
drug information associations would be usefulMust have a thorough
knowledge of clinical research concepts, practices, and FDA
regulations and ICH Guidelines regarding drug development phases,
clinical research, and medical writing standards; demonstrated
ability to interpret and apply these guidelines to document
writing. Familiarity with basic statistical analysis concepts and
techniques is requiredA demonstrated track record of contribution
to successful regulatory components used in filings eg, IND/CTAs,
NDA/BLA/MAAs is importantPrior experience in interacting with
cross-functional study team members is essentialHighly proficient
in the use of MS Word, Excel, Endnote, Adobe Acrobat, PowerPoint,
and structured document templatesPreferred:
Post-graduate degree (masters or
doctoral)Experience writing in one or more of the company's key
therapeutic areas, eg, liver disease, oncology, or rare
diseasesExperience with electronic document management
systemsExperience managing contractors or in-house medical
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Keywords: Arrowhead Pharmaceuticals, Pasadena , Principal Medical Writer, Advertising , Pasadena, California
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