Job description
Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.
- Build and lead the medical writing department by managing internal and external medical writers and assessing resource needs to meet the organizational goals.
- Establish key document development processes, standards and style guides in collaboration with a cross-functional team.
- Plan and lead submissions of clinical and regulatory documents (e.g., IND/NDA applications, protocols, eCTD clinical/nonclinical summaries/IMPD and briefing books)
- Develop and maintain SOPs relevant to medical writing function.
- Develop and maintain Company standard templates and best review practices for regulatory and clinical documentation; ensure vendors and contractors maintain company standard.
- Ensure smooth and effective document management from template to a final approved version.
- Ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards and style guides.
- Oversee document review and comment resolution meetings with cross-functional teams.
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.
- Bachelor’s degree in a scientific discipline required, advanced degree preferred.
- Minimum of 15 years of relevant clinical and regulatory writing experience; 12 years’ experience with Masters or 10 years’ experience with PhD.
- Minimum of 5 years of management experience.
- Solid understanding of the clinical development process, including the regulatory documentation that is required at each stage.
- Familiar with eCTD structure, and experience with eCTD summary documents (e.g. Modules 2.5 and 2.7) and/or regulatory briefing document.
- Demonstrated ability to develop effective strategies to ensure clear and concise messages and scientific concepts, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately.
- Strong leadership, planning and project management skills, along with initiative and ability of being productive with minimal supervision and support.
- Excellent oral and written communication skills.
- Flexible and adaptive work style to meet organization needs.
- Working knowledge of FDA, EMA and ICH regulatory guidance and regulations.