Associate Director, Medical Writer
Company: Horizon Therapeutics
Location: Rockville
Posted on: June 14, 2022
Job Description:
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. Position Summary: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
guidelines.Responsibilities:
- 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
experience.
- Previous experience with document authoring in Veeva RIM is a
plus.
- Track record of developing high-quality clinical development
and scientific documents.
- 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
priorities.
- 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: Growth
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent Accountability
- Drives Results
- Ensures Accountability
- Decision Quality Transparency
- Courage
- Collaboration
- Instills Trust 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, Rockville , Associate Director, Medical Writer, Advertising , Rockville, Maryland
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