Senior Associate, Regulatory Review
- 1675 Broadway, New York, NY 10019, 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 Senior Associate, 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 knowing and creating components of a submission package based on medium, agility in working in VEEVA and/or various other submission platforms, managing reference library that includes collecting and validating according to SSW or clients’ specifications, facilitating communication among team members about the status of projects currently underway, training brand teams, and data entry. Maintaining communication and cooperation on projects and processes across Saatchi & Saatchi Wellness (SSW) teams regarding all types of submission preparation and delivery: print, digital, video, and social media is vital. In addition, identifying ways to improve on process and efficiencies, as well as a high level of organization and attention to detail are required to ensure submissions are correct and error-free.
Core Duties and Responsibilities
- Prepare completed digital marketing tactics for MLR review board
- 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 submission requirements and ensure these protocols are maintained
- Experience with VEEVA or other submissions platform
- Comfort in onboarding new/existing staff
- Proofread against multiple source documents to check for accuracy
- Prioritize work effectively to meet all client deadlines
- Act as a point of contact for internal account teams and project management
- Attend and contribute to brand team status meetings
- Collaborate with internal, multidisciplinary team members (Account Services, Delivery, Design, User Experience, etc.)
- Stay abreast of regulatory industry trends
- Enforce strict preset procedures and regulations set forth by client MLR review teams and FDA guidelines
- Preferred 1-2 years of experience in the preparation of complex deliverables
- Experience in Pharmaceutical Industry or Healthcare is preferred.
- 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
- Strong 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
- 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.