We are seeking an experienced Medical Writer to manage, write and edit scientific, clinical and regulatory documents, communications and publications for all Alpine programs.
· Manage scientific and/or medical writing activities for all Alpine programs. May manage contractors and/or other staff writers.
· Write, edit and facilitate the review of study reports, study protocols, investigator's brochures, clinical data summaries, and other medical/regulatory documents, including the development and management of timelines, as well as publications such as abstracts, posters, Powerpoint presentations, manuscripts.
· Responsible for study registration and results disclosure in compliance with US and EU requirements.
· May oversee clinical library / information systems
· May develop standards and processes for scientific and/or clinical document production
Desired Skills and Experience
· Bachelor's degree in a life sciences discipline (advanced degree preferred) and a minimum of 2 years biopharmaceutical industry experience.
· Experience preparing regulatory documents and scientific publications. Prior regulatory submission experience preferred, including eCTD standards.
· In-depth understanding of regulatory/ICH guidelines and GxPs, Good Publication Practices (GPP) and related standards (e.g. CONSORT, ICMJE), and clinical trial transparency requirements (e.g. EudraCT, CT.gov)
· Expert abilities in Microsoft Office Suite, Adobe Acrobat, and electronic content management systems.
· Strong written and verbal communication skills
· Experience in oncology and/or inflammatory disease drug development. Successful experience in managing teams and mentoring staff preferred.
· Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment.
· Exceptional attention to detail.