Medical Writer (Contractor)

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