Advertising Manager II || New Jersey (Remote)

Role: Advertising Manager – II

Location: New Jersey (Remote)

Job Description:

• Inviting applications for the role of Lead Consultant in Regulatory Affairs Publisher
• You should have relevant years of experience in Publishing - regulatory affairs.

Responsibilities

Regulatory Submission Management:

• Provide support in Project management of dossier compilation, ensure transparent cross-functional planning and tracking of the compilation process.
• Leads initial Submission Kick-off partnering with Strategist.
• Owner of dynamic Submission Project Plan timelines capturing dependencies for each Module and Dispatch Date.
• Coordinate content related Team/Management Reviews.
• Establish, maintain, and adhere to Submission Project Plan timelines agreed upon as a team: Identify documents on the critical path.
• Review of approved submission documents of Module 2 as per submission content plan.
• Conduct and participate submission team meetings with GRS and maintain positive relationships with contributors/partners and oversee submission content plan from Module 2 to Module 5.
• Communicate changes/critical updates during tracking team meetings to team members and Escalation of issues if timelines are at risk to be delayed.
• Participate in Technical Quality Review for Modules 1-5 for final approval for utmost quality and sign off for on-time dispatch to Health Authorities
• Frequent exchange and close collaboration and support with GRSs
• Provide guidance to publishers while compiling content and publishing of submission dossier, preparing dispatch of dossiers and submitting to Health authorities.

Qualifications we seek in you!

Submission Publishing:

• Submission Publishing and performing final technical quality review and technical validation (eCTD) for Canada and US submissions.
• Should have knowledge about NDS, ANDS, IND, DMF, NDA and BLA submissions. E g Safety Submissions, Annual reports, OPDP submissions, Protocol and amendment, Original application.
• Notifying relevant stakeholders that the Submission is ready for approval
• Dispatching submission to HC and US FDA through ESG Gateway.
• Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;
• Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence.

Requirements

• In depth working knowledge of industry standard publishing systems and desktop applications.
• Expertise with Publisher applications
• Effective communication, time management and organizational skills.
• Technical Trouble shooting
• Flexibility to adapt to a changing environment,
• Demonstrated project management and leadership skills.
• Skilled at fostering customer relationships and driving collaboration.
• Understanding of global regulatory processes and requirements.
• Strong attention to detail, ability to multi-task.
• Expertise with industry standard electronic document management system
• 5 years in Publishing and/or related Regulatory/Pharmaceutical area

Qualifications

• Pharmacy/Science

Preferred Qualifications / Skills

Key Attributes

• Enthusiasm & confidence
• Adhere to our principles and values.
• Time Management skills.