Associate Director, Medical Writing in San Diego, CA

$150K - $200K(Ladders Estimates)

Halozyme Therapeutics, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 43 days ago

POSITION SUMMARY:

The Associate Director, Medical Writing is the functional head of the medical writing team at Halozyme and has the overall responsibility of quality, targets and timelines for the medical writing activities at Halozyme. He/She is responsible for authoring and reviewing clinical documents and for the planning and coordination of the medical writing activities to ensure compliance with the company goals. He/She possesses experience and expertise to train and develop in-house and contract writers on medical writing activities.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include, but are not limited to:


  • Write, assign, review and edit clinical documents such as protocols, clinical study reports (CSRs), investigator brochures, clinical summaries, and other documents for submission to health authorities
  • Lead and manage the medical writing team
  • Develop the medical writing team in terms of resources, skills and competencies
  • Evaluate the functional needs and allocate writers, resources and workload; estimate and manage budget for contract writer resources
  • Provide functional support, and plan, coordinate and be responsible for the review of all study documents produced by in-house and contract writers
  • Track all projects assigned to the in-house and external writers, coordinate and track advance planning, deliver according to timelines
  • Consistently provide feedback and information on the projects and specific activities of the medical writing team to senior management
  • Establish procedures and policies to be applied to writing activities; develop, maintain and improve medical writing processes
  • Keep professional information and technology knowledge current, including through conferences
  • Demonstrate good organizational and interpersonal skills with attention to detail
  • Comply with established company policies and procedures, objectives, quality assurance programs, safety, and environmental standards

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:


  • Engage and manage external writing resources, as needed
  • Identify recruitment needs in the medical writing team and manage the hiring process, as appropriate
  • Assist in the preparation of scientific manuscripts, abstracts, PowerPoint presentations, and posters, as needed
  • Assist in the development of other SOPs related to clinical development activities, when appropriate
  • Provide additional support to the medical writing team and the clinical team, as needed
  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:


  • Minimum of a MA/MS with 8 years of medical writing experience or PhD with 2 to 5 years of medical writing experience at a university, scientific institution, or biotech/pharmaceutical company (an equivalent combination of education and experience, i.e. PhD with at least 6 years' experience, may be considered)
  • At least 4 years' experience successfully managing and mentoring medical writer staff
  • Previous experience managing medical writing vendors ensuring adherence to SOPs, industry guidelines and deliver high quality documents on time within budget
  • Comprehensive understanding of the drug development process
  • Demonstrated ability to work both independently and in team environments
  • Strong written and verbal communication skills
  • Attention to detail with an ability to detect errors and inconsistencies in various types of documents
  • Proven project management skills including the ability to manage medical writing deliverables for multiple studies
  • Demonstrated ability to work well with others in high pressure situations, including the ability to juggle multiple projects and tasks simultaneously
  • Clinical research experience in the biopharmaceutical industry preferred

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained

Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Familiarity with graphics programs (PowerPoint, Adobe Creative Suite) is desirable

INTERNAL AND EXTERNAL RELATIONSHIPS:


  • Routine interface with members of Clinical Development and other internal departments
  • Interface with and management of vendors including CROs and consultants


Valid Through: 2019-10-29