Director/Senior Director, Quality Systems and GxP Compliance
Scholar Rock
Vault
Principal Medical Writer, Global Medical Writing
Deciphera Pharmaceuticals
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $164,000 - $226,000 per year
Job Level
Lead
Tech Stack
Vault
About the role
- Lead writer across programs/submissions for clinical study-related documents (protocols, IBs, CSRs)
- Lead cross-functional teams in development of regulatory submission and response documents
- Author and manage preparation of clinical documents with high quality, organization, clarity, accuracy, and adherence to guidelines
- Drive document strategies and messages collaboratively with subject matter experts
- Maintain knowledge of current field developments and incorporate process improvements
- Plan and coordinate work with in-house Medical Writer team and outside CROs
- Mentor junior team members and review deliverables including SAPs, TFLs as needed
- Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and participate in submission planning
Requirements
- PhD or equivalent plus 5+ years of experience or Bachelors/Masters plus 10+ years of experience
- Expert knowledge of and experience in preparing high quality clinical and regulatory documents
- Knowledge of clinical trial disclosure
- Submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in preparation of summary documents
- Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
- Strong organizational/prioritization skills for the management of multiple concurrent documents
- Demonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please Review
- Oncology, immunology, and/or neurology experience is highly preferred
