- Within a designated therapeutic area the Principal Medical Writer Program Lead formulates the writing strategy for key clinical documents and regulatory submissions. Guides medical writing (MW) document preparation, including coordination and oversight of assignments to MW vendor (s). Assumes primary medical writing responsibility for preparation of key regulatory response documents and strategic documents supporting major regulatory submissions. Formulates writing approach, develops timelines, and assesses resource requirements. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including US and international regulatory guidance and requirements for content and format, Company requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. Leverages external resources to achieve quality, timely and cost-effective compound level submission deliverables.
location: Cambridge, Massachusetts
job type: Contract
salary: $85.00 - 98.30 per hour
work hours: 9 to 5
- Leads a single team which guides medical writing activities within a designated therapeutic area for key response documents and regulatory submissions.
- Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
- Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
- Coordinates and provides oversight for the activities of medical writing vendor(s) (, and ensures resolution of issues.
- Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Company requirements and processes across development programs.
- As required, serves as lead writer for strategic regulatory documents and key components of regulatory submissions.
- Provides leadership on functional teams that address requirements or issues related to document preparation and production.
- The Principal Medical Writer Program Lead is seen as an expert in medical writing and performs work independently with minimal supervision.
- Bachelor's degree in science, health profession, or journalism required.
- At least 5 years' experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
- Experience as lead writer for key documents included in major US and/or international regulatory submissions required
- Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
- Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
- Ability to understand Company guidelines and requirements related to the preparation and production of regulatory documents and submissions.
- Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
- Knowledge of team dynamics and ability to function as a team leader
skills: Editing, IND, FDA, GCP (Good Clinical Practice), CTD Structure, ICH Regulations
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.