Sr. Manager/Associate Director, Medical Writing
The position, reporting to the Sr. Director, Head of Global Regulatory Portfolio Management, with a dotted line report to the Interim Head of Medical Writing, will be the medical writing lead for clinical regulatory documents. A successful medical writer will be able to write independently and work effectively with cross-functional colleagues to develop documents efficiently and with high quality.
- Write or oversee the writing of regulatory submission documents (e.g., clinical protocols, investigator brochures [IBs], clinical study reports [CSRs], eCTD/BLA clinical summaries, and briefing documents for regulatory interactions)
- Maintain timelines and ensure smooth and effective document management from conception to final signature (i.e., generation of a blank document to a final approved version), including management of various processes (e.g., QC, formatting, publishing, document archiving)
- Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required to ensure adherence to standards
- Lead or oversee document review and comment resolution meetings with cross-functional teams
- Interpret clinical study data as needed for document preparation
- Perform literature-based research to support writing activities as needed
Education and Experience:
- BS, MS, or doctorate in a scientific or medical field
- 8+ years of experience within the biotechnology/pharmaceutical industry with 5+ years of medical writing experience for clinical regulatory documents
- Experience in rare diseases, and/or neuroscience preferred
- Demonstrated experience as a primary author, writing and editing regulatory scientific documents; preparation of protocols, IBs, CSRs, briefing documents for regulatory interactions and experience on at least one eCTD/NDA/BLA/MAA submission
- Experience with global clinical study/regulatory submission preferred
- Strong document management and project management skills, along with initiative and ability to be productive with minimal supervision
- Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures
- Understands and effectively responds to multicultural communication styles and business practices with internal colleagues and vendors
- Ability to build and maintain effective partnerships, both internally and externally
Competencies and Attributes:
- Demonstrated leadership ability to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
- Exceptional oral and written communication skills
- Flexible; adapts work style to meet organization needs
- Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
- Dedicated to quality and reliability
- Excellent computer skills (Veeva, Microsoft Office Suite; Project and Visio experience a plus)
- Approximately 10% travel is anticipated
Prothena is a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for rare peripheral amyloid and neurodegenerative diseases.
We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our diversified portfolio is designed to make a significant impact on rare peripheral amyloid and neurodegenerative diseases.
Prothena’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta).
Prothena’s partnered programs include prasinezumab, which targets alpha-synuclein, in collaboration with Roche for the potential treatment of Parkinson’s disease, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of neurodegenerative diseases.