Senior Medical Writer

Prepare study documents such as protocol synopses, protocols, protocol amendments, clinical study reports (CSRs), and other documents in accordance with regulatory requirements and Agenus SOPs.
Full Time Remote in United States Medical Writing
Annually: USD 0 - 0
(UTC-08:00) Pacific Time (US and Canada)
Medical Writer
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We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

In the role you will:

Tasks may include but are not limited to:

  • Prepare study documents such as protocol synopses, protocols, protocol amendments, clinical study reports (CSRs), and other documents in accordance with regulatory requirements and Agenus SOPs.
  • Prepare product documents such as investigator’s brochures (IBs), development safety update reports (DSURs), summary documents, and others in accordance with regulatory requirements and Agenus SOPs.
  • Coordinate internal and external document review cycles.
  • Attend project-related meetings, as needed.
  • Perform review and QC of documents, as needed.
  • Serve as publishing point-of-contact in conjunction with Document Coordination to publish CSRs or other documents, as needed.
  • Create and manage project-specific timelines, adaptation of timing and milestones based on team needs/feedback.
  • Identify and appropriately communicate risks associated with document delivery and propose mitigation plans.
  • Advise project team on Medical Writing-related issues.
  • Complete project-specific and company training, as assigned.
  • Perform other duties as assigned.

OTHER SKILLS AND ABILITIES:

  • Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner.
  • Excellent project/time management and organizational skills, and ability to work independently.
  • Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
  • Comprehensive Microsoft Office, especially WORD but also PowerPoint and Excel skills, as well as internet skills.
  • Ability to communicate with professionals from a variety of backgrounds.
  • Attention to detail—style, consistency, grammar, syntax, scientific accuracy.
  • Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).

 Qualifications: About You

  • University/college degree (life science or related allied health profession) and American Medical Writers Association (AMWA) Certification or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities.
  • Graduate degree preferred.
  • Minimum of 3 years of clinical pharmaceutical industry experience including skills and competency in Medical Writing.
  • Available for domestic and international travel, including overnight stays (valid passport), as needed.

Posted 6 months ago

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