Job Description
We are a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Our team offers remote or on-site services, focusing on delivering clear, concise, accurate, and fully compliant documentation throughout the drug development process, from early stages to post-approval.
We are seeking an organized, motivated, and collaborative individual to join our medical writing team. As a Principal Medical Writer, you will work closely with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Program Management to lead the planning and preparation of high-quality clinical and regulatory documents. This role involves producing a variety of documents, including protocols, publications, study reports, investigator brochures, narratives, and module documents, in accordance with client and agency guidelines while meeting tight deadlines.
Location: Fully remote position, with a preference for candidates who can attend on-site roundtable meetings with clients as needed.
Essential Duties & Responsibilities
Strategic Leadership: Provide strategic direction for medical writing projects as the lead writer, including the development of key submission messages with cross-functional input and the creation of project lexicons with harmonized terms.
Client Liaison: Serve as the main point of contact for clients regarding issues that span multiple document types.
Project Management: Organize and proactively manage content execution, timelines, and resources to ensure successful project delivery.
Collaboration & Review: Coordinate activities, conduct reviews, and substantively edit contributions from cross-functional team members.
Mentorship: Mentor junior writers, helping them develop soft skills needed for effective team collaboration, comment resolution, and fostering a positive authoring experience.
Internal Coordination: Facilitate input from internal stakeholders and coordinate internal resources (e.g., quality control [QC], publishing).
Expertise in Documentation: Serve as an expert on document management systems and related tools, templates, and procedures to streamline document production.
Meeting Facilitation: Plan and lead kickoff meetings and roundtable discussions for each document draft; vet comments following team reviews to ensure productive meetings.
Consistency Assurance: Ensure consistency across client programs in messaging, formatting, and presentation of documents.
Quality Control: Perform peer QC reviews as needed.
Operational Contributions: Contribute to medical writing operational initiatives, such as templates, style guides, and reference management.
Requirements
Experience: 10+ years of experience as a medical writer in the CRO, biotech, or pharmaceutical field, or equivalent.
Education: Advanced degree preferred.
Oncology Knowledge: Experience in oncology is a plus.
Lead Writing Experience: Proven experience as a lead writer for key documents and successfully managing major submissions.
Regulatory Familiarity: Knowledge of requirements for preparing key clinical and regulatory documents, including ICH and US/EMA regulations; familiarity with other ex-US regulatory requirements is desired.
Technical Proficiency: Expertise with Microsoft Word and other Microsoft applications; familiarity with document management systems.
Work Style: Ability to work independently and collaboratively while managing competing priorities.
Project Management: A service-oriented and proactive approach to project management.
Communication Skills: Excellent conflict management and negotiation skills, along with strong written and verbal communication abilities.
We are committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
To Apply: For further information or to submit your application, please reach out to our email. Be cautious of any messages that do not come from our official email address or HR system, as phishing scams are increasingly prevalent.
Employment Type: Full-Time
Salary: $ 55,000.00 158,000.00 Per Year
Job Tags
Full time, Remote job,