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