- 375 Hudson St, New York, NY 10014, USA
Walk the halls of SSW and you'll find a rather spirited and passionate group of people. It's a stimulating assembly of professionals—writers, managers, strategists, art directors, planners, analysts and developers.
We believe the only way to move people to live healthier, happier lives is to create ideas that move them emotionally. Never powered by reason alone, people – whether they’re consumers, caregivers, doctors or payers – are motivated to take action by emotion. Only when people feel something will they be willing to do something.
For decades, Saatchi & Saatchi Wellness has provided consumer and professional marketing, strategic consulting and medical education to pharmaceutical and wellness brands. Today, we're dedicated to continuing that legacy by raising the bar and crafting award- winning work online, on-air, in print and in-office. Going beyond addressing simply the absence of illness, our vision is to inspire a healthier, happier world. Together, we strive to help brands thrive in today’s culture of wellbeing by leveraging the power of Wellness IntelligenceSM.
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
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
All your information will be kept confidential according to EEO guidelines.