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Medical Writer (Contractor)

Remote

Responsibilities:

  • Prepares, edits, reviews, and finalizes regulatory documents and related clinical documents of all complexity levels
  • Provides conceptual contributions to projects; participates and contributes to regulatory and clinical development strategy, as needed
  • Leads cross-functional teams in document preparation, including but not limited to, development of content strategy, coordination of content contributions, development and maintenance of applicable timelines
  • Collaborates with cross-functional team to interpret study results and ensure messaging is consistently reflected across relevant regulatory documents
  • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
  • Ensures that medical writing deliverables are compliant with International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Create, maintains, and ensure corporate compliance with standard operating procedures and work instructions for applicable clinical regulatory deliverables
  • Proactively identifies and subsequently leads initiatives that improve quality, efficiency, and productivity of medical writing processes and templates
  • Contribute to vendor oversight as needed
  • May serve as functional area representative
  • Participate in interdepartmental activities as deemed necessary

Qualifications:

  • Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in BLA areas; graduate degree (master’s or doctoral) preferred
  • An understanding of the drug development process
  • Broad experience managing the medical writing responsibilities associated at various stages
  • Experience interacting with cross-functional study team members
  • Must have a thorough knowledge and experience in the application of regulatory and clinical research concepts, practices, medical writing standards , and Health Authority Guidelines across drug development phases
  • Ability to work independently with minimal supervision; possess excellent project management skills; attentive to details
  • Ability to communicate with teams; monitor and communicate progress against milestones; escalate complex issues appropriately.
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
  • Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
  • Read, write and speak fluent English; excellent verbal and written communication skills

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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