Medical Writer

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Following Fusion's June 2020 IPO, the Company has cash to fund operations into 2024.

The Medical Writer / Sr. Medical Writer will be responsible for creating/authoring/managing clinical and pre-clinical documents required to support clinical trials and regulatory submissions as well as for publications and presentations. The medical writer may lead strategy discussions related to document development and drive activities for process improvements. This position will report to the Head of Clinical Operations.

Position Responsibilities:

  • Independently prepares complex clinical, pre-clinical and regulatory documents including clinical synopses, protocols, study reports, investigator brochures, and annual reports/DSURs for multiple programs
  • Coordinates the efforts of cross-functional teams to produce high-quality, scientifically accurate documents and ensure consistency between related documents
  • Leads document-related meetings, participates in cross-functional team meetings
  • Manages medical writing timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Performs and/or manages quality control reviews of clinical, pre-clinical and regulatory documents

Education/Experience:

  • Bachelor's degree is required. Master's degree or PhD preferred
  • At least 3 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required
  • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
  • Ability to comply with company and/or industry style guides and templates
  • Strong attention to detail
  • Ability to create strong, collaborative working relationships. Demonstrate excellent verbal/written and interpersonal skills required to effectively communicate and collaborate in a cross-functional team environment
  • Effective in identifying issues and driving team towards creative solutions and smart decisions
  • Strong organizational and meeting skills

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary($): Undisclosed

Position Type: Full Time

To view the entire job posting or to apply for this position, join the Xtalks community for free. Advance your career, get access to industry webinars, articles, videos, and more.

Similar Jobs


Cambridge, United States

Manager, Medical Writing (Remote)

Alnylam is the world’s leading RNA interference (RNAi) company. Founded ...

Princeton, United States

Clinical Trial Manager

Genmab is focused on the creation and development of innovative and diff...

Bloomington, United States

Clinical Data Manager

Principal Data Manager position is to oversee data operations tasks for ...

Canada

Clinical Trial Manager (CTM)

The Clinical Trial Manager (CTM) is responsible for the operational mana...