Researcher / analyst
Dendreon is seeking a Sr. Medical Writer who will lead content development for scientific communication including abstract, scientific poster and oral presentations as well as manuscripts. He or she will be an integral member of medical affairs publication team. Other responsibilities may include the development of medical information letters, MSL slide decks, and the preparation of clinical reports, summary documents, package inserts, etc. A self-motivated individual with strong oral and written communication skills is needed for this critical position.
Prepare scientific manuscripts, abstracts and posters in collaboration with both internal medical team and external KOLs.
Pro-actively manage timelines and cross-functional meetings to meet submission-specific requirements.
Work closely with both internal and external stakeholders including KOLs to generate and update scientific content.
Collaborate with medical science liaisons and Medical Information team in developing MSL slide decks and medical information letters.
Research, write and edit pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.
Ensure the development of formats and guidelines for documentation that meet departmental and industry standards.
Coordinate with clinical research associates and medical doctors in clinical protocol development.
Keep abreast of professional information and technology through conferences.
Represent department in cross-functional teams, projects and GPP-related problem resolution.
Master’s degree in a scientific discipline or equivalent. Doctoral degree (PhD, PharmD, DVM) is preferred in life sciences, immunology, pharmacology, epidemiology, clinical research and other relevant fields.
A minimum of 3 years’ scientific research and medical writing experience in pharmaceutical industry.
Knowledge of FDA regulatory requirements, ICH, GPP and ICMJE guidelines.
Proficient in MS Office applications.