Medical Writer – Contractor
ProKidney Corp.
contract
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- 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
Requirements
- 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.
Benefits
- Equal employment opportunity employer
- Does not discriminate based on protected classes.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingregulatory documentsclinical documentscontent strategyproject managementstandard operating proceduresregulatory guidelinesHealth Authority GuidelinesBLA writingdrug development process
Soft skills
excellent communication skillsinterpersonal skillsactive listeninginfluencing skillsattention to detailindependent workflexibilitypersistenceteam collaborationproblem-solving