Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com
Job Description: The Medical Writing Contractor will write and support the development of various clinical and regulatory documents. In addition, this individual may conduct QC activities supporting the delivery of accurate, compliant, and submission-ready documents. The individual may also support public disclosure documents (e.g., initial registrations and results postings in Clinicaltrials.gov and EudraCT).
Responsibilities:

• Provide expert medical writing for the programs and efforts of the Clinical Development and Regulatory Affairs groups. Documents can include and are not limited to: Clinical Study Protocols and amendments, Informed Consent Forms, Clinical Study Reports, IND/NDA/MAA applications and summaries, Style Guides, Briefing Documents, DSURs, Investigator Brochures and regulatory responses.
• Accountable for managing the review process for each document, including setting up adjudication meetings with subject matter experts to arrive at resolution, mapping and adhering to timelines for document completion and coordinating with QC, QA and Regulatory Publishing.
• Ensure document content and format adheres to applicable templates, ICH/FDA/EMEA or other appropriate regulatory guidelines, style guidelines, and applicable company SOPs
• Follow and interpret regulatory guidelines (e.g., ICH, FDA) that apply to the type of document he/she is responsible for writing.
• Request literature searches to obtain background information for development of documents as necessary
• Participate in electronic document publishing efforts
• Provide independent Quality Control review of documents authored by other writers to ensure accurate, compliant, and submission-ready documents. Documents can include and are not limited to: Clinical Study Protocols and amendments, Informed Consent Forms, Clinical Study Reports, IND/NDA/MAA applications and summaries, Briefing Documents, Investigator Brochures and regulatory responses.
• Verify the accuracy of document content using source documents including clinical regulatory documents (e. g., protocols, clinical study reports, CIOMS reports, clinical summaries/overviews) and data tables, figures, and listings
• Verify compliance and uniformity of documents with both internal and external standards (e.g., document templates, company style guide, publishing requirements)
• Record QC findings and identify appropriate corrections to address findings
• Verify internal consistency within a document and across related documents
• Collaborate with document authors and other team members, as needed, to resolve QC findings

Qualifications:

• BA with 10 years, MS with 6 years, or a MD, PharmD, or PhD with 4 years or more experience in the research, pharmaceutical, or biotechnology industry
• Strong scientific/medical/health-related background
• Minimum of 5 years’ relevant medical writing industry; oncology experience is desirable
• Proven track record of writing high quality regulatory documents
• Demonstrated knowledge and understanding of business processes, regulatory affairs, and other requirements (e.g., GCP, eCTD, ICH)
• Basic knowledge of clinical trials, clinical development, biostatistics, and regulatory
• Experience preparing CTD summary documents for US NDA or EU MAA submission
• Ability to concisely analyze, interpret, and communicate data.
• Ability to deliver quality results in a dynamic, fast-paced environment with multiple priorities
• Expert user of Microsoft Office and working knowledge of Adobe Acrobat
• Ability to learn and use document management systems (e.g., Documentum); experience working in document management systems is a plus
• Excellent organizational, project management and communication skills

Pay Range: $80 - 115/hour W2 only