Regulatory Operations Manager - Multiple Positions Open

For decades, Saatchi & Saatchi Wellness has provided consumer and professional marketing, strategic consulting, and medical education to pharmaceutical and wellness brands. Our mission is to inspire a healthier, happier, well-er world through award-winning work.

If you google us (which you may have done already), you’ll see that spreading wellness is literally our mission. We don’t just talk about making your well-being the most important thing, we mean it. Having a flexible hybrid-work policy, plentiful time off, and colleagues who want you to do well are all part of the gig. Oh, and of course the opportunity to work on some of the good-vibiest campaigns on the planet with very caring, very resourceful people. So, if you’re a rockstar writer, aspiring strategist, jill—or jack—of all trades, or just an all-around nice person, let’s chat.

Job Description

The Manager, Regulatory Review is responsible for ensuring regulatory submissions follow the protocols established by our pharmaceutical and medical/surgical device clients for promotional materials. This includes managing components of a submission package based on project type, experience working in Veeva and/or various other submission platforms, managing reference library uploads [includes collecting and validating according to SSW or clients’ specifications], facilitating communication among team members about the status of active projects, training brand teams, and data entry. This role also supports others in the dept by reviewing submissions, training and onboarding staff, identifying ways to improve process and efficiencies, and alerting others to changing submission practices. The ideal candidate for this role will be knowledgeable about projects and processes across Saatchi & Saatchi Wellness (SSW) teams regarding submission preparation and delivery. This role may have direct reports at the Associate/Senior Associate level as appropriate.

Core Duties and ResponsibilitiesProvide guidance to PM and Account teams as they prepare projects for Medical Legal Regulatory (MLR) reviewSubmit completed materials to the client, both electronically and/or in hard copy, as determined by the clients’ specificationsMaintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlinesUnderstand 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 reviewTrain others on use/process and ensure these protocols are maintained and shared out to the dept or the Agency on a regular basisPrioritize work effectively to meet all client deadlines across your own assigned brands and for others in the deptManage direct reports at the Associate and/or Senior Associate level as neededComfort in onboarding new/existing staff and provide consistent guidance and feedbackComfort with having direct reportsAct as a point of contact for internal Account and Project Management teams to answer submission questionsLevel of comfort in contacting Client’s promo as requiredAttend and contribute to internal/external team status meetingsCollaborate with internal, multidisciplinary team members (Account Services, Project Management, Design, User Experience, etc.)Stay abreast of regulatory industry trends

Qualifications

Preferred 2-3 years of experience working in submissionsExperience in Pharmaceutical Industry or Healthcare MarketingProficiency using Veeva submission softwareMust demonstrate clear, concise technical writing abilityMust be articulate with strong attention to detail and proficient reading comprehensionExcellent spelling, grammar and proofreading skillsAbility to successfully organize, prioritize and manage complex projects in a deadline-driven environment is a mustManagement experience with direct reports a plusExcellent problem-solving skillsProficiency in Windows and Mac programs, web and mobile platforms, Microsoft Office Suite, Adobe Acrobat, and Screenshot capture softwareAbility to follow strict procedures and meet deadlinesSelf-motivated and committed to completing assigned tasksComfort in providing feedback to othersStrong communication and interpersonal skills, a positive attitude and the ability to thrive in a collaborative agency environment with multi-disciplinary teams required

Additional Information

The Power of One starts with our people! To do powerful things, we offer powerful resources. Our best-in-class wellness and benefits offerings include:Paid Family Care for parents and caregivers for 12 weeks or moreMonetary assistance and support for Adoption, Surrogacy and FertilityMonetary assistance and support for pet adoptionEmployee Assistance Programs and Health/Wellness/Comfort reimbursements to help you invest in your future and work/life balanceTuition AssistancePaid time off that includes Flexible Time off Vacation, Annual Sick Days, Volunteer Days, Holiday and Identity days, and moreMatching Gifts programsFlexible 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 alliancesThe benefits offerings listed are available to eligible U.S. Based employees, are reviewed on an annual basis, and are governed by the terms of the applicable plan documents.

SSW is an Equal Opportunity Employer. Our employment decisions are made without regard to actual or perceived race, color,ethnicity, religion, creed, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, childbirth and related medical conditions, national origin, ancestry, citizenship status, age, disability, medical condition as defined by applicable state law, genetic information, marital status, military service and veteran status, or any other characteristic protected by applicable federal, state or local laws and ordinances.

If you require accommodation or assistance with the application or onboarding processspecifically, please contacthrcompliance_usms@publicis.com.

All your information will be kept confidential according to EEO guidelines.

Compensation Range: $64,500 - $101,500 annually. This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time. For this role, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off.The Company anticipates the application deadline for this job posting will be 6/1/2024.