Senior Associate, Regulatory Review
- Full-time
Company Description
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.
Job Description
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
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 to client processes
Proofread against multiple source documents to check for accuracy prior to submissions
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 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 1-2 years of experience working in submissions
Experience in Pharmaceutical Industry or Healthcare Marketing
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
Additional Information
All your information will be kept confidential according to EEO guidelines.