The Director, Medical Writing reports to the CMO and will support Clinical Science, Regulatory, and Safety functions.
- Manage, write, and edit clinical, regulatory, and safety documents for Iovance programs.
- Write clinical study protocols and amendments, Investigator's Brochures, DSURs, and other medical/regulatory documents.
- Develop and manage timelines and resources. Collaborate cross-functionally to drive projects to completion.
- Write, and oversee the writing and review of documents toward regulatory submissions such as INDs and BLAs.
- Write publications such as abstracts, posters, PowerPoint presentations, manuscripts.
- Develop standards and processes for clinical document production.
- May manage additional medical writers (employees and contractors).
- May oversee clinical library/information systems (Endnote).
- Other duties as assigned.
Education and Qualifications:
- PhD/master's degree in a life sciences discipline (advanced degree preferred) or equivalent experience and a minimum of 12 years' biopharmaceutical industry experience.
- Experience drafting clinical protocols and Investigator's Brochures. Prior regulatory submission experience preferred, especially work toward IND and BLA submissions.
- In-depth understanding of regulatory/ICH guidelines and GCPs, Good Publication Practices (GPP) and related standards (eg, CONSORT, ICMJE), and clinical trial transparency requirements (eg, EudraCT, CT.gov).
- Expert abilities in Microsoft Office Suite, Adobe Acrobat, Visio, and electronic content management systems (SharePoint).
- Experience with cross-functional collaboration and with managing priorities, timelines and writing resources.
- Strong written and verbal communication skills.
- Experience in oncology drug development.
- Experience working independently and leading teams to successful submissions.
- Sit for extended period in front of computer
Posting ID: 567400109Posted: 2020-08-09