SUMMARY:

This position will be responsible for the review and submission of advertising/promotional materials in compliance with FDA regulations and guidance documents. This position will also support additional regulatory activities related to commercial and investigational products, as required.

RESPONSIBILITIES:

• Review of advertising/promotional materials, internal training materials and disease state materials to ensure compliance with Regulatory requirements.
• Represent Regulatory Affairs in AdProm Committee meetings.
• Maintain current awareness of evolving regulations and guidance documents relating to promotional materials and labeling, including advisory and enforcement letters.
• Manage/prepare pre-clearance, advisory comments, and 2253 submissions to the FDA’s Office of Prescription Drug Promotion.
• Review and update standard operating procedures.
• Other regulatory activities as assigned.

REQUIRED SKILLS, EDUCATION AND EXPERIENCE:

• Bachelor’s degree required in Chemistry or Life Sciences.
• Minimum of 7 years proven experience in the review of advertising/promotional materials for drug products and biologics.
• Detailed knowledge of FDA regulations and guidance documents pertaining to labeling and advertising/promotional materials.
• Knowledge in the preparation of submissions in eCTD format desired.
• Demonstration of positive interaction skills and work ethic.
• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail required.
• Capable of working independently and in a team environment.
• Ability to manage multiple tasks simultaneously.
• Ability to successfully negotiate in a team environment.
• Excellent skills with MS Word, Excel, PowerPoint, and Document Management Systems (ex. Veeva, SharePoint, etc.).

AVAILABILITY:

• Must be available to work in the evenings and weekends, as required.

POSITION LOCATION AND/OR TERRITORY AND TRAVEL:

• Position is in the United States (Irvine, CA or Cambridge, MA).
• Position may require occasional travel.

SPECTRUM PHARMACEUTICALS is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Required Skills Required Experience

• Understanding of Federal contracting bid process
• Familiar with Shipley proposal process
• Keen attention to detail and follow-through skills
• Expert-level proficiency in Microsoft Office 2010 (including Excel, Outlook, PowerPoint, Project, and Word), SharePoint (required), and Adobe Acrobat Professional
• Strong analytical skills, attention to detail, and excellent proofreading abilities
• Ability to synthesize information and present findings clearly in both writing and orally
• Ability to give clear, concise directions and organize large volumes of information
• Comfortable speaking with executive and senior-level management teams
• Ability to work in a fast-paced environment, often with short notice, to meet tight deadlines
• Excellent interpersonal skills
• Ability to work under pressure, handle last-minute requests, and multitask
• Able to effectively prioritize and work independently
• Ability to successfully communicate with proposal team, teammates, corporate executive management, and other employees at all levels
• Must possess demonstrated abilities to work under and tight deadlines, work independently and as part of a team prioritizing multiple tasks efficiently and effectively
• Ability to maintain a positive attitude under stress and ability to work with a diverse group of personalities
• Excellent organizational skills, writing skills, and oral communication skills.
• Understanding of US Government contracting proposal processes
• Ability to travel 25% to work on-site with Proposal Team when requested, typically Atlanta GA
• Participate and support proposal review meetings as assigned