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Director, Regulatory/Medical Writing

Company: Arrowhead Pharmaceuticals
Location: Pasadena
Posted on: September 9, 2020

Job Description:

The Position:Arrowhead is seeking an experienced Regulatory/Medical Writer to join its Regulatory Affairs team. The Regulatory/Medical Writer will work collaboratively with Arrowheads regulatory, clinical and scientific teams to produce high quality documents to support the companys 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.Responsibilities:Prepare, 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 sources;Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved;Prepare abstracts, posters, presentations, and manuscripts; assist in the development and maintenance of quality and product documentation;Advise and assist in the review and management of nonclinical and CMC technical reports;Develop and maintain Company house-standard templates and best review practices for regulatory and clinical documentation; ensure vendors and contractors maintain company standards;Ensure 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 improvements;Ensure 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:Bachelors 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 writing.A 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 PowerPointPreferred:Post-graduate degree (masters or doctoral)Medical writing experience in liver disease, oncology, or rare diseasesFamiliarity with statistical analysis concepts and techniquesPasadena, CA Full Time Regulatory Affairs Experienced

Keywords: Arrowhead Pharmaceuticals, Pasadena , Director, Regulatory/Medical Writing, Advertising , Pasadena, California

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