Regulatory Operations Manager - Multiple Positions Open

Company Description

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 Responsibilities 

• 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 

Qualifications

• 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 

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