Manager, Technical Submission, Regulatory Advertising and Promotions Job at Fresenius Kabi
Job Summary
Fresenius Kabi has an exciting opportunity for a Manager, Technical Submission, Regulatory Advertising and Promotions. This position reports to the Director of Regulatory Operations.
The Technical Submission Manager is responsible for the on-time filing of high-quality submissions to the Office of Prescription Drug Promotion (OPDP) and any other maintenance thereafter for the Pharmaceutical and Biosimilar divisions of the company. Responsible for the electronic submission compilation and transmission of advertising and promotional materials to the appropriate regulatory agencies. Maintains effective working relationships with Marketing, and the entire RA department. Participates in management discussions, mentors, and provides strategic regulatory guidance as it relates to the advertising and promotional material submissions/requirements.
Responsibilities
The technical submission manager is responsible for:
- Defining and implementing electronic submission strategies surrounding advertising and promotional material submissions
- Adheres to and gains expertise with appropriate compliance requirements as well as regulatory agency processes
- Coordinates with the advertising and promotional manager to prioritize the workload to meet changing business demands without losing focus on the objectives
- Strategically supports the transition from paper to electronic submission format
- Develops process for tracking of OPDP submissions to improve operational efficiency
- Develops and implements quality standards for OPDP submissions
- Provides training support, as necessary, to the publishers that will serve as a backup to the technical submission manager
- Serves as an expert resource for OPDP electronic submission requirements; if necessary, participates as a regulatory representative on project team meetings and provides regulatory guidance
- Ensuring submission integrity
- Ensuring documents are properly formatted in accordance with company standards and agency guidelines, e.g., hyperlinking / bookmarking files.
- Communicates and raises issues clearly and at an appropriate level of detail
- Develops ideas and solutions for simple problems while contributing to solutions for complex problems
- Follows regulatory guidelines regarding placement of documents in regulatory submissions as defined by the agency requirements.
- Applies comprehensive understanding of concepts within own technical area in providing recommendations
- Managing compilation and transmittal of OPDP submissions to regulatory agency(ies) in accordance with the agreed timelines
- Ensures the submission accuracy and compliance with internal policies as well as agency guidelines and regulations
- Coordinates with the publishing team for submission sequencing
- Independently collects and compiles the final/approved submission documents then completes and signs the necessary agency form(s) for the OPDP submission; Acts as the company’s OPDP submission contact person with regulatory agency(ies)
- Compiles the OPDP submissions using the electronic publishing software and electronic data management systems then transmits thru the appropriate agency portal
- Manages time and resources to meet project deadlines as well as develops a contingency plan to prepare for potential setbacks
- Leads and/or collaborates with other managers in the development and maintenance of procedures and tools that supports the electronic submission processes to promote compliance
- Actively seeks ways to improve processes and identifies areas for improvement
- If necessary, interfaces with IT personnel to resolve software/hardware issues, including but not limited to upgrades and validation activities
- Projecting professionalism and a courteous, cheerful and cooperative demeanor at all times
- Maintain ongoing relationships with stakeholders and colleagues by establishing trust, transparency, and collaboration
- Demonstrates company core values in daily work
- Performing additional tasks and duties as assigned by Manager
Requirements
- BS / BA required
- 5+ years of regulatory publishing experience
- Must be proficient with Microsoft Word and Adobe Acrobat applications
- Must have previous experience in dealing with the FDA
- Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’s, as it pertains to advertising and promotional materials
- Demonstrated effective oral and verbal communication skills
- Well-developed decision-making skills, attention to detail, and superior organization skills
- Proficient in standard business software applications and an aptitude for electronic systems and software
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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