Regulatory Operations Manager - Multiple Positions Open
Saatchi & Saatchi
- New York City, NY
- $64,500-101,500 per year
- Permanent
- Full-time
- Provide guidance to PM and Account teams as they prepare projects for Medical Legal Regulatory (MLR) review
- Submit completed materials to the client, both electronically and/or in hard copy, as determined by the clients’ specifications
- Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines
- Understand and document client mandated MLR submission requirements including maintaining a working knowledge of the client’s internal tools/systems for uploading and routing projects for review
- Train others on use/process and ensure these protocols are maintained and shared out to the dept or the Agency on a regular basis
- Prioritize work effectively to meet all client deadlines across your own assigned brands and for others in the dept
- Manage direct reports at the Associate and/or Senior Associate level as needed
- Comfort in onboarding new/existing staff and provide consistent guidance and feedback
- Comfort with having direct reports
- Act as a point of contact for internal Account and Project Management teams to answer submission questions
- Level of comfort in contacting Client’s promo as required
- Attend and contribute to internal/external team status meetings
- Collaborate with internal, multidisciplinary team members (Account Services, Project Management, Design, User Experience, etc.)
- Stay abreast of regulatory industry trends
- Preferred 2-3 years of experience working in submissions
- Experience in Pharmaceutical Industry or Healthcare Marketing
- Proficiency using Veeva submission software
- Must demonstrate clear, concise technical writing ability
- Must be articulate with strong attention to detail and proficient reading comprehension
- Excellent spelling, grammar and proofreading skills
- Ability to successfully organize, prioritize and manage complex projects in a deadline-driven environment is a must
- Management experience with direct reports a plus
- Excellent problem-solving skills
- Proficiency in Windows and Mac programs, web and mobile platforms, Microsoft Office Suite, Adobe Acrobat, and Screenshot capture software
- Ability to follow strict procedures and meet deadlines
- Self-motivated and committed to completing assigned tasks
- Comfort in providing feedback to others
- Strong communication and interpersonal skills, a positive attitude and the ability to thrive in a collaborative agency environment with multi-disciplinary teams required
- Paid Family Care for parents and caregivers for 12 weeks or more
- Monetary assistance and support for Adoption, Surrogacy and Fertility
- Monetary assistance and support for pet adoption
- Employee Assistance Programs and Health/Wellness/Comfort reimbursements to help you invest in your future and work/life balance
- Tuition Assistance
- Paid time off that includes Flexible Time off Vacation, Annual Sick Days, Volunteer Days, Holiday and Identity days, and more
- Matching Gifts programs
- Flexible working arrangements
- ‘Work Your World’ Program encouraging employees to work from anywhere Publicis Groupe has an office for up to 6 weeks a year (based upon eligibility)
- Business Resource Groups that support multiple affinities and alliances