The Associate Director (AD), Medical Writing, will be responsible for development and oversight of key clinical/regulatory documents ensuring clinical data is presented objectively in a clear, concise format in compliance with ICH guidelines and local regulatory requirements. The AD will collaborate with Study Conduct Teams, Project Teams, and other functional leads to develop document strategy and support consistent documents/messaging within and across programs. The AD will support development of Medical Writing's roles and responsibilities in alignment with the company's needs.
location: Philadelphia, Pennsylvania
job type: Permanent
salary: $170,000 - 180,000 per year
work hours: 9 to 5
- Manage or oversee multiple writing projects to support company, department, and project team goals with respect to project scope, messaging, timelines, other activity planning, and budgeting/resourcing.
- Serve as lead writer on key documents including Investigator Brochures, Protocols, Clinical Study Reports and BLA clinical summary documents; own and maintain relevant document templates
- Provide writing strategy for product development with the vision to identify immediate and future document writing needs.
- Ensure efficient preparation and completion of high-quality, accurate, concise, and ICH-compliant medical writing deliverables.
- Collaborate with functional and other cross-functional representatives to develop or improve document planning/writing/QC standards, SOPs, style guide and processes as well as to identify potential areas where Medical Writing may expand its services.
- Organize and lead functional and cross-functional document planning, strategy, adjudication, or other team meetings.
- Point of contact for all Medical Writing needs and related topics.
- Oversee medical writing vendor performance and activity with regard to medical writing and QC in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations and other associated documents.
- Participate in Clinical Operations and cross functional initiatives such as process improvements and SOP development.
- Develop and maintain/evaluate key performance indicators /metrics for medical writing and QC
- Provide support in the identification of training gaps, may support development of training materials to meet the gap and provide training as required to improve core competency and skill set for all staff contributing authoring or contributing to clinical and regulatory documents.
- Preferred Bachelor's Degree in Science or Medical related field with 8+ years industry experience, Master's Degree with 6+ years industry experience, or PhD with 5+ years industry experience.
- Experience with most of the more common regulatory documents such as CSRs, IBs, protocols, and clinical modules. Advantageous to have experience with a broader range of regulatory or process documents, such as plain language summaries, Advisory Committee Meeting support, Briefing Documents, subject safety narratives, SOPs, and templates.
- Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs.
- Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities.
- Preferable to have a solid technology background to support electronic/automated initiatives that result in more efficient and higher quality writing.
skills: NDA, CSR, Advisory committee
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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