Job Description
About Us: We are a global consortium of experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. We provide both remote and on-site services, with a commitment to delivering clear, concise, accurate, and compliant documentation throughout the drug development process, from early stages to post-approval.
Overview: We are looking for an organized, motivated, and collaborative individual to join our medical writing team as a Principal Medical Writer. In this role, you will work closely with cross-functional teams, including Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management, to lead the planning and preparation of high-quality clinical and regulatory documents. Your contributions may include protocols, publications, study reports, investigator brochures, narratives, and module documents, all developed in accordance with client and regulatory guidelines under tight timelines.
Location: This is a fully remote position, with the preferred ability to attend on-site roundtable meetings with clients as needed.
Key Responsibilities:
Provide strategic direction for medical writing projects as the lead writer, collaborating with cross-functional teams to develop key messages and project lexicons with harmonized terminology.
Act as the primary point of contact for clients, addressing issues that span multiple document types.
Organize and manage the execution of content, timelines, and resources proactively.
Coordinate activities and conduct substantive edits of contributions from cross-functional team members.
Mentor junior writers, helping them develop the soft skills necessary for effective teamwork, comment resolution, and promoting a positive authoring experience.
Gather input from internal stakeholders and manage internal resources, such as quality control and publishing.
Serve as an expert on the client document management system and related tools, templates, and procedures to streamline document production.
Plan and lead kickoff and roundtable meetings for each document draft; review comments following team feedback to facilitate productive discussions.
Ensure consistency in messaging, formatting, and presentation across client programs.
Perform peer quality control reviews as necessary.
Contribute to medical writing operational initiatives, such as template development, style guides, and reference management.
Qualifications:
Over 10 years of experience as a medical writer in the CRO, biotech, or pharmaceutical industries, or equivalent experience.
An advanced degree is preferred.
Experience in oncology is a plus.
Proven track record as a lead writer for key documents.
Experience managing major submissions successfully.
Familiarity with the requirements for preparing key clinical and regulatory documents, including ICH and US/EMA regulations; knowledge of other international regulations is desirable.
Proficient in Microsoft Word and other Microsoft applications.
Familiarity with document management systems.
Ability to work both independently and collaboratively while managing competing priorities.
A service-oriented and proactive approach to project management.
Excellent conflict management and negotiation skills.
Strong written and verbal communication skills.
Employment Type: Full-Time
Salary: $ 150,000.00 Per Year
Job Tags
Full time, Remote job,