Associate Director, Medical Writer
Company: Horizon Therapeutics
Posted on: June 24, 2022
Working at Horizon is more than a job - it's personal. For us,
success is measured by the numbers that matter most - the number of
lives we touch, the number we change and those we work tirelessly
to help save. We're a team of agile, out-of-the-box thinkers who
are inspired to do more because we know we're a part of something
bigger. We strive to build meaningful careers at a company whose
values we share because when we live up to our potential, we help
others live up to theirs.
The Associate Director, Medical Writing is expected to provide
leadership within the Medical Writing function and the larger
Regulatory department. Works with minimal supervision to manage and
prioritize assignments to ensure deliverables are completed per
time and quality goals. Manages outside vendors/contractors
providing additional medical writing support in conjunction with
other Medical Affairs team members.
The Associate Director, Medical Writing is expected to be able to
advise and collaborate with cross-functional colleagues on document
strategy, authoring and review processes, establishing best
practices to generate high quality clinical and regulatory
submission documents in compliance with ICH/GCP/regulatory
Write, edit, contribute to, and manage the development of a variety
of clinical and regulatory documents, as well as other documents
per business needs.
Ensure smooth and effective document management from start to
finish (i.e., from template to final approved version), including
but not limited to first draft authoring, coordination of review
and adjudication, generation of bibliographies, and adherence to
the style guide.
Review, edit, and ensure quality of documents or sections of
documents prepared by other writers (internal or contractors) or
functional area representatives, as required, ensuring adherence to
applicable standards and requirements.
Support the development, implementation, and improvement of best
practices, the document process, and SOPs as needed.
Develop and maintain templates and outlines for key documents.
Qualifications and Skills Required:
At least 5-8 years of experience in medical or scientific writing
in the pharmaceutical or biotech industry.
Requires a PhD/PharmD in a medically relevant scientific
discipline, or a master's degree with 4 years of relevant work
Previous experience with document authoring in Veeva RIM is a
Track record of developing high-quality clinical development and
In depth knowledge of the drug development and approval processes
and GCP principles.
Strong leadership, planning, and project management skills, along
with initiative and ability to be productive with minimal
supervision and minimal administrative support.
Ability to work collaboratively and coordinate the efforts of team
members to resolve comments and complete deliverables.
Ability to manage/prioritize multiple projects under general
supervision, working in a fast-paced environment.
Flexible and able to adapt to changing deadlines and
Strong written, verbal, and interpersonal communication skills.
Highly attentive to detail.
Self-motivated and able to self-manage effort to maintain alignment
with corporate goals.
Proficiency in the use of Microsoft Office applications and
experience working in electronic document management systems.
Horizon Core Values & Competencies:
Horizon requires all U.S. employees to be fully vaccinated, as a
condition of employment, with either Pfizer (fully approved by the
U.S. Food and Drug Administration), Moderna or Johnson & Johnson
(currently granted emergency-use authorization by the FDA). "Fully
vaccinated" is defined as two weeks after your final dose of the
Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide
medical and religious accommodations as required by law.
Horizon Therapeutics plc does not discriminate on the basis of
race, color, religion, gender, sexual orientation, national origin,
age, disability, veteran status, or any other characteristic
protected by law. It is our intention that all qualified
applications are given equal opportunity and that selection
decisions be based on job-related factors. Any individual, who,
because of a disability, needs accommodation or assistance in
completing this application or at any time during the application
process, should contact the Human Resources Department.
Keywords: Horizon Therapeutics, Harrisburg , Associate Director, Medical Writer, Executive , Rockville, Pennsylvania
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