What are the responsibilities and job description for the Regulatory Operations Specialist position at OLIXIR New York?
Agency
Olixir
Job Function
Production
Job Subfunction
Production Operations
Job Description
As the Regulatory Operations Specialist, you will manage regulatory submissions for client brands to ensure accuracy and efficiency while following industry standards. Your role requires strong organizational and communication skills, with the ability to work collaboratively in a fast-paced environment.Manage day-to-day workload for 1-3 client brands, prioritizing tasks to meet deadlines and staying up-to-date on standard operating procedures.
Communicate effectively with agency team members, providing updates on submission status, requirements, and challenges.
Maintain accurate trackers and process decks, ensuring compliance with agency administrative processes and ways of working.
Coordinate submission activities, including uploading documents, tracking status, and downloading MLR comments.
Collaborate with internal teams, sharing information and best practices to ensure seamless submission processes.
Ensure compliance with regulatory requirements, uploading relevant supporting documents and linking tactics to component assets as needed.Associate's or Bachelor's degree preferred, with 1 year of experience in pharmaceutical advertising or a related regulated industry.
Veeva PromoMats Certification and experience with submission portals (e.g., Veeva Vault, Aprimo) preferred.
Strong planning, problem-solving, and organizational skills, with proficiency in Microsoft Office Suite and Teams.
Excellent written and verbal communication skills, with the ability to work effectively in a fast-paced environment.
Understanding of MLR submission processes, fact checks, and reference annotations, with ability to navigate submission portals.
Ability to work proactively and independently, with strong time management skills and a team-oriented approach.
to be updated
To the extent permissible by local law, Omnicom’s policy requires employees to work in the office for a minimum of three days a week, unless additional in-office days are directed by their agency or manager.
Omnicom is committed to hiring and developing exceptional talent. We agree that talent is uniquely distributed, and we’re focused on developing inclusive teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us—we look forward to getting to know you. We will process your personal data in accordance with our Recruitment Privacy Notice.
Link to Recruitment Privacy Notice: https://www.omc.com/privacy-notice
For US Job Seekers
It is the policy of Omnicom and any of its affiliates to provide equal employment opportunities to all employees and applicants for employment without regard to race, religion, color, ethnic origin, gender, gender identity, age, marital status, veteran status, sexual orientation, disability, or any other basis prohibited by applicable federal, state, or local law. EOE/AA/M/D/V/F.
,
to be updated
Olixir
Job Function
Production
Job Subfunction
Production Operations
Job Description
As the Regulatory Operations Specialist, you will manage regulatory submissions for client brands to ensure accuracy and efficiency while following industry standards. Your role requires strong organizational and communication skills, with the ability to work collaboratively in a fast-paced environment.Manage day-to-day workload for 1-3 client brands, prioritizing tasks to meet deadlines and staying up-to-date on standard operating procedures.
Communicate effectively with agency team members, providing updates on submission status, requirements, and challenges.
Maintain accurate trackers and process decks, ensuring compliance with agency administrative processes and ways of working.
Coordinate submission activities, including uploading documents, tracking status, and downloading MLR comments.
Collaborate with internal teams, sharing information and best practices to ensure seamless submission processes.
Ensure compliance with regulatory requirements, uploading relevant supporting documents and linking tactics to component assets as needed.Associate's or Bachelor's degree preferred, with 1 year of experience in pharmaceutical advertising or a related regulated industry.
Veeva PromoMats Certification and experience with submission portals (e.g., Veeva Vault, Aprimo) preferred.
Strong planning, problem-solving, and organizational skills, with proficiency in Microsoft Office Suite and Teams.
Excellent written and verbal communication skills, with the ability to work effectively in a fast-paced environment.
Understanding of MLR submission processes, fact checks, and reference annotations, with ability to navigate submission portals.
Ability to work proactively and independently, with strong time management skills and a team-oriented approach.
to be updated
To the extent permissible by local law, Omnicom’s policy requires employees to work in the office for a minimum of three days a week, unless additional in-office days are directed by their agency or manager.
Omnicom is committed to hiring and developing exceptional talent. We agree that talent is uniquely distributed, and we’re focused on developing inclusive teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us—we look forward to getting to know you. We will process your personal data in accordance with our Recruitment Privacy Notice.
Link to Recruitment Privacy Notice: https://www.omc.com/privacy-notice
For US Job Seekers
It is the policy of Omnicom and any of its affiliates to provide equal employment opportunities to all employees and applicants for employment without regard to race, religion, color, ethnic origin, gender, gender identity, age, marital status, veteran status, sexual orientation, disability, or any other basis prohibited by applicable federal, state, or local law. EOE/AA/M/D/V/F.
,
to be updated