- Supports Drug Product Development Department in regulatory filing section authoring for vaccine drug product formulation and process development as well as drug product manufacturing. May also review sections and perform data verification to source information.
location: Cambridge, Massachusetts
job type: Contract
salary: $50.00 - 57.27 per hour
work hours: 9 to 5
- Primary responsibilities include:
- Author and review of drug product formulation development, process qualification and production filing documentations including IND/IMPD and briefing books.
- Preparation and review of technical and summary reports to support regulatory submissions. Collaborate cross functionally with SMEs, Regulatory and Quality
- Regulated Responsibilities
- Report document life cycle coordination and/or preparation.
- Regulatory submission coordination
- General quality compliance.
- B.S. with at least 10 years or M.S. with at least 6 years of experience in bio- pharmaceutical manufacturing (vaccine manufacturing experience strongly preferred).
- Extensive experience with drafting regulatory sections for BLA/MAA, IND/IMPD filings and briefing books
- Strong technical writing skills with significant understanding on biologic or vaccine drug product manufacturing processes
- Experience with audit inspections and the preparation of responses to regulatory submission questions from agencies
- Able to manage conflicting priorities and adhere to tight timelines.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail.
- Strong knowledge of word processing applications, database structure, multiple computer applications: electronic document management systems (Documentum or similar applications), EndNote, Oracle, SharePoint.
- Ability to work on several documents at the same time, high attention to detail and accuracy, ability to consistently hit deadlines, excellent written and oral communication skills.
- High level of competency required in teamwork for departmental and cross-functional project teams.
- Fundamental knowledge of worldwide regulatory submissions guidance's a plus.
- Licenses/ Certifications l N/A
- Physical Demands l N/A
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Typical office and laboratory bending, stooping, lifting requirements apply.
- Lifting and moving supplies and equipment (up to 50 pounds).
- Limited number of travel may be required
skills: Editing, IND, GCP (Good Clinical Practice)
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.