Job Description

The Principal Medical Writer provides medical writing and publication support for clients.

Essential Functions Include:

• Lead cross functional coordination of consultants to manage medical writing and quality control deliverables.
• In conjunction with the VP and/or Sr. Director of Medical Writing, defines and manages medical writing and quality control resource needs, communicates with recruiting and business development in a timely and effective manner.
• Ensures appropriate communication on project and program-related matters with VP and/or Sr. Director of Medical Writing, internal functional heads, and consultants.
• Manages clinical program documents (such as protocols, investigator’s brochures, informed consent forms, patient narratives, clinical study reports, eCTD summary documents, and various regulatory documents from Pre-IND stage to NDA submission) for assigned clients.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas.
• Creates writing deliverables that include, but may not be limited to:
  • clinical study protocols and clinical protocol amendments;
  • clinical study reports;
  • clinical development plans;
  • IND submissions and annual reports;
  • Integrated summary reports;
  • NDA and (e)CTD submissions;
  • investigator brochures, as well as;
  • clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Coordinates quality control (QC) reviews of documents and maintains audit trails of changes.
• May perform QC review if requested by supervisor (e.g., QC in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc.).

Qualifications

Qualified candidates must have:

• Bachelor’s degree in the life sciences; MS or PhD preferred.
• Minimum of 5 years of experience in the writing regulatory documents for pharmaceutical, biologic or medical device companies.
• Expert word processing skills in MS Word, including proficiency with tables, graphs, and figures are required.
• Must be able to work in a collaborative team environment.
• Strong computer skills, project management skills, and a high attention to detail.
• Excellent demonstrable understanding of ICMJE and GPP guidelines and regulations required.
• Ability to write presentations and articles for peer reviewed publications that conform to prescribed style and format.
• Ability to work with mathematical concepts such as probability and statistical inference.
• Knowledge of internet software, spreadsheet software, word processing software, graphics software (e.g., PowerPoint), bibliographic software e.g. EndNote) and any other applicable software as may be needed by the job from time to time as it changes.
• Must demonstrate strong experience in relationship-building and experience in collaborating with large and strategic accounts.
• Proven team player who can focus and continuously reinforce efforts to meet timelines.
• Exceptional time management skills.

Additional Information

• All candidates must be legally eligible to work in the United States.
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.