Director, Medical & Scientific Writer (San Diego Based)

Location
San Diego, CA
Salary
Base plus Bonus plus Options!
Posted
Jun 01, 2018
Required Education
Bachelors Degree
Position Type
Full time

This an exciting time to join a rapidly growing and dynamic Arena, with a robust portfolio of assets across multiple therapeutic areas.  We are in search of a service-oriented Director, Medical and Scientific Writer (DMSW) will act as a subject-matter-expert (SME) for the medical and scientific function. This writer is responsible for the creation of documents pertaining to clinical and safety data to support scientific product development and license applications on behalf of, and in conjunction with, corresponding project teams. The medical writer supports writing activities across departments assisting in numerous areas including authorship of abstracts, CSRs, regulatory submissions, posters and manuscripts, style guides and templates, and patient education materials. 

What you’ll dive into

  • Partners with key stakeholders to plan for the writing of protocols, study reports, consent forms, investigator brochures, health authority meeting briefing packages, CTD summaries, etc.
  • Provides expertise on regulatory requirements and ensures assigned documents are produced in accordance with such guidance and relevant internal SOPs
  • Provides strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents
  • Contributes to overall project management and cross functional working groups to facilitate development and finalization of assigned documents; ensure quality and consistency among formatting and style
  • Builds roadmap and deliverables for assigned projects

What we expect

  • Bachelor’s degree in related field, scientific PhD degree highly preferred
  • 12 years of relevant and progressive experience
  • 5+ years of experience working in biotech/pharma/scientific industry
  • Recent and significant experience in writing regulatory documents such as Clinical Study Reports, Protocols, Summaries and Overviews
  • Experience in Phase I, II and III Clinical Trials documentation required; Commercialization of a asset is preferred
  • Expert ability to synthesize clearly written analyses of integrated patient data from single pivotal and multiple studies
  • Advanced understanding of medical concepts and significant familiarity with medical terminology
  • Experience with EDMS administration, publishing software, and writing tools (e.g. ISI Writer, preferred
  • Ability and passion to work in demanding, dynamic, fluid and fast-paced environment
  • Demonstrated ability to be strategic and hands-on
  • Demonstrated ability to interpret complex analyses of data supporting regulatory submissions
  • Demonstrated ability to lead and drive others
  • Demonstrates excellent communication skills
  • Travel up to 10%, including international

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays including a Summer & Winter break
  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com,