at Horizon Therapeutics in Remote, United States
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.
Primary responsibility is to develop high-quality scientific documents to support development programs. Oversee outside vendors and internal medical writing team, in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals.
+ Responsible for preparation of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc.
+ Oversees and participates in the development of documents for assigned programs in compliance with company standard operating procedures (SOPs). This may include developing timelines, authorship, review/approval workflow management, and/or QC/publication readiness.
+ Works with cross-functional internal teams to ensure wide acceptability of documents.
+ Manages external service providers/contractors to ensure delivery of outsourced documents/projects.
+ Manages internal medical writer(s) to ensure delivery of documents/projects.
+ Critically analyzes, synthesizes, and presents complex information.
Qualifications and Skills Required:
+ Advanced scientific or clinical degree (MD, PhD, or PharmD) required.
+ Minimum of 5-9 years with a strong current working knowledge of the pharmaceutical environment.
+ Track record of developing high-quality scientific documents.
+ Proficiency in the use of Microsoft Office applications and experience working in electronic document management systems.
+ General knowledge of the drug development and approval processes and GXP principles.
+ Ability to work with high-level contacts and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment.
+ 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
+ Excellent written, verbal, and interpersonal communication skills. Highly attentive to detail. Self-motivated and able to self-manage effort to maintain alignment with corporate goals.
Horizon Core Values & Competencies:
+ Manages Ambiguity
+ Strategic Mindset
+ Demonstrates Self-awareness
+ Cultivates Innovation
+ Develops Talent
+ Drives Results
+ Ensures Accountability
+ Decision Quality
+ Instills Trust
Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with Pfizer that has been fully approved by the Food & Drug Administration (FDA) or one of the vaccines currently granted emergency use authorization by the FDA such as Moderna or Johnson & Johnson. Fully vaccinated is defined as two weeks after your final dose of the Pfizer, Moderna or Johnson & Johnson vaccine. We 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.
Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter , LinkedIn , Instagram and Facebook .To view full details and how to apply, please login or create a Job Seeker account