Director, Regulatory/Medical Writing
Company: Arrowhead Pharmaceuticals
Location: Pasadena
Posted on: May 8, 2024
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Job Description:
Arrowhead Pharmaceuticals, Inc.
A variety of soft skills and experience may be required for the
following role Please ensure you check the overview below
carefully.
(Nasdaq: - ARWR) is a clinical stage biopharmaceutical company that
develops medicines that treat intractable diseases by silencing the
genes that cause them.
Using a broad portfolio of RNA chemistries and efficient modes of
delivery, Arrowhead therapies trigger the RNA interference
mechanism to induce rapid, deep, and durable knockdown of target
genes.
RNA interference, or RNAi, is a mechanism present in living cells
that inhibits the expression of a specific gene, thereby affecting
the production of a specific protein.
Arrowhead's RNAi-based therapeutics leverage this natural pathway
of gene silencing.Arrowhead is focused on developing innovative
drugs for diseases with a genetic basis, typically characterized by
the overproduction of one or more proteins that are involved with
disease.
The depth and versatility of our RNAi technologies enables us to
potentially address conditions in virtually any therapeutic area
and pursue disease targets that are not otherwise addressable by
small molecules and biologics.
Arrowhead is leading the field in bringing the promise of RNAi to
address diseases outside of the liver, and our clinical pipeline
includes disease targets in the liver and lung with a promising
pipeline of preclinical candidates.Arrowhead's corporate
headquarters is in Pasadena, CA with research and development teams
in Madison, WI and San Diego, CA. - Our employees are nimble,
science-driven innovators who are collaborating to bring new
therapies to patients in need. -The PositionArrowhead is seeking an
experienced Regulatory/Medical Writer to lead its Medical Writing
Team. - The Regulatory/Medical Writer will work collaboratively
with Arrowhead's regulatory, clinical and scientific teams to
produce high quality documents to support the company's drug
development programs.
S/he will focus on the preparation of regulatory and clinical
documentation for submission to global regulatory agencies and
assist with the preparation of publications, abstracts, and other
external and internal communications. - (S)he is responsible for
developing and implementing processes and standards to ensure
company documentation is prepared to the highest editorial
standards and quality, and to lead the Medical Writing
Team.ResponsibilitiesLead Medical Writing TeamPrepare, edit, and
finalize protocols, investigator brochures, synopses, clinical
study reports, regulatory documents (INDs/NDAs, annual reports,
Orphan Drug Designation applications, Agency Response to Questions,
briefing books, etc.)Collaborate with the clinical and scientific
staff for narrative and data presentation planning, gather material
for relevant documents and ensure that documents accurately reflect
sourcesManage the document review process and schedule and conduct
meetings to ensure documentation timelines are achievedPrepare
abstracts, posters, presentations, and manuscripts; assist in the
development and maintenance of quality and product
documentationAdvise and assist in the review and management of
nonclinical and CMC technical reportsDevelop and maintain Company
house-standard templates and best review practices for regulatory
and clinical documentation; ensure vendors and contractors maintain
company standardsEnsure that documentation conforms to
International Conference on Harmonization (ICH) and other relevant
regulatory guidelines and medical editorial boards; ensure that
appropriate documented quality control (QC) checks are performed
and recommends quality process improvementsEnsure documents are
generated in accordance with agreed internal processes and
standards, are submission ready, and are appropriately stored in
appropriate document management system(s)Requirements: -Bachelor's
degree in medical-related field or life scienceA minimum of 6-8
years of relevant medical writing experience in the pharmaceutical
industryThorough 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 writingA demonstrated track record of
contribution to successful regulatory components used in filings
e.g.
IND/CTAs, NDA/BLA/MAAs is importantExperience interacting and
communicating timeline expectations with cross functional study
team membersExperience with electronic document management
systemsHighly proficient in the functionality of MS Word, Excel,
Endnote, Adobe Acrobat, and PowerPointExperience managing Medical
Writer staff member(s)Preferred: -Post-graduate degree (master's or
doctoral)Medical writing experience in cardiovascular, pulmonary,
or rare diseasesFamiliarity with statistical analysis concepts and
techniquesCalifornia pay range $210,000-$245,000 USDArrowhead
provides competitive salaries and an excellent benefit package. - -
-All applicants must have authorization to work in the US for a
company. - - -California Applicant Privacy Policy
Keywords: Arrowhead Pharmaceuticals, Malibu , Director, Regulatory/Medical Writing, Advertising , Pasadena, California
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