Regulatory Affairs Specialist jobs in Daly City, CA

Marketing Operations Manager  - OneSource Regulatory

Join the OSR Team to transform Marketing/Commercial Operations and the way you work.

About OneSource Regulatory

OneSource Regulatory™ helps companies implement the correct solutions, processes, standards, systems, templates, and best practices for effective Regulatory Operations.  With the right Regulatory Operations group, our clients can achieve high quality document management, data management, and regulatory agency submissions.

  Today we provide the following exemplary Marketing/Commercial operations services:

• Commercial Operations Infrastructure Build & Support Project Management - (Policy, Process, and Procedure Development)
• Promotion Review Committee (PRC) Process Management
• Technical E-Review System Implementation
• Marketing/Promotional Materials Execution Project Management (Production and Dissemination of Materials)
• HCP & Patient Speaker Bureau and Program Operations Management
• Medical Congress Planning (Exhibits, Meetings & Events Management)
• Vendor/External Partner Procurement & Management

What You’ll Do

Do you want the opportunity to work with a diverse group of pharmaceutical companies and provide commercial marketing support for some of the most innovative products in the industry - from the comfort of your home?

OneSource Regulatory (OSR), is seeking qualified Marketing Operations Managers  based in the US.  You should be a collaborative team member who provides the following services to our clients and their agency partners:

• Coordination and oversight of the promotion review process as well as other promotion related processes for assigned brands or therapeutic categories
• Responsible for forecasting promotion review team needs, through collaboration with sales communications, training, brand managers, and other marketing support functions
• Lead all prioritization discussions for the assigned promotion review team and communicate agreed upon agendas to reviewers and job owners who will be presenting during the meeting
• Provide counsel to job owners on planning for the review process including timing considerations, type of review to consider, and guidance documents to review
• Provide oversight of materials being added to the promotion review team agenda to ensure that minimum quality and promotion review guidance has been followed
• Facilitate promotion review team meetings to ensure meetings are efficient and conducted according to guidance
• Communicate information provided during promotion review meetings to the broader team when appropriate
• Clarify, review, reconcile, and document the comments on review materials during live PRC meetings & ensure final approval from PRC reviewers
• Oversee the copy proofing process and production process of final approved materials with agency/external partners
• Interact with Agency Partners and Regulatory/Regulatory Operations Managers for the submission of promotional materials to OPDP for initial use (Form FDA 2253)
• Partner with job owners and other stakeholders in the execution of job reapprovals and tactics related to label changes for assigned brands

Qualifications:

• Bachelor degree is required (Focus in Business, Medical, Science, Marketing, or Communications is preferred)
• 10 years of related experience in the pharmaceutical/ biotech industry is required (For Sr level team leader roles) - May consider related experience from healthcare advertising agency
• 7 years related experience in the pharmaceutical/ biotech industry is required (for individual contributor roles on the team) - May consider related experience from healthcare advertising agency
• Functional experience in regulatory, medical, pharmaceutical marketing operations, sales or communications preferred
• Product launch or advertising agency account management experience is a plus.
• Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion
• Understanding of pharmaceutical review and approval process is preferred
• Deep understanding of the advertising/creative development process
• Strong project and process management experience (in pharma industry preferred)
• Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. - Proficiency in Veeva Vault Promo Mats or other electronic review platforms

You should have a strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.

The OneSource Regulatory team is comprised of the top experts in Marketing/Commercial Operations.  OSR team members have an average of 15 years of industry experience in large, mid-size and small companies across every therapeutic area.

At OSR, you will be offered interesting and challenging work, and your position will come with a competitive salary, a flexible schedule and innovative incentive programs that reward your contributions and innovations.  You will have the opportunity for personal and professional development through internal coaching and mentoring, in addition to the opportunity to attend key external events.

Learn more about OSR by visiting our website:  www.OneSourceRegulatory.com

Questions?  Email us at info@OneSourceRegulatory.com

Interested in joining the OSR Team? 

Provide your information through the BambooHR form below.