Senior Manager/Associate Director Regulatory Advertising and Promotion

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!

This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.

 
location: Cambridge, Massachusetts
job type: Contract
salary: $165 - 175 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
The role of Senior Manager/Associate Director of Regulatory Advertising and Promotion requires the ability to provide regulatory strategic advice on global and U.S. communications for promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of company business objectives. This individual will effectively partner and collaborate with cross-functional stakeholders and ensure that materials are competitive and compliant with applicable FDA regulations, PhRMA guidelines, and company policies.

• Provide regulatory strategic input, risk assessment, and mitigation strategies to various global and U.S. internal teams on branded and unbranded concepts, promotional materials, disease awareness communications, medical communications and sales training/education materials
• Provide creative and solution-oriented feedback to meet business goals and further business objectives
• Provide strategic advice for the development of Advisory Comments submissions
• Ensure promotional materials are consistent with FDA-approved labeling, compliant with applicable FDA regulations, and completed in accordance with 2253 submissions requirements
• Develop and maintain strong working relationships with internal colleagues including, but not limited to: Commercial, Medical, Legal, Compliance, Regulatory Strategy, and Medical/Marketing Operations
• Work with management and Reg AP team members to ensure communications and feedback are generally consistent across therapeutic areas
• Assist Regulatory Ad Promo department in monitoring evolving regulatory landscape and communicating updates to internal stakeholders

 
qualifications:

• BS required; advanced degree preferred
• Minimum of 3-5 years of Regulatory promotional review
• Detail and deadline oriented; well organized
• Capability to analyze and assess risk and then effectively communicate across interdisciplinary teams
• Ability to dissect and interpret complex disease information and product efficacy/safety data
• Demonstrates strong negotiation and interpersonal skills to influence others and build team collaboration, consensus and partnerships
• Adapts to dynamic environment and business needs
• Ability to develop and maintain relationships with OPDP
• Excellent verbal, written, and presentation skills
• Positive individual who demonstrates integrity and agility while working in fast-paced and compliant environment to advance external HCP, payor, and patient initiatives.
• Consistently manages and prioritizes multiple and competing responsibilities for an expanding business that strives to meaningfully change the lives of people living with serious neurological diseases.

 
skills: Regulatory Affairs Operations, Submissions

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).



For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.