Associate Principal Scientist, Post Market Safety, L'Oréal Research & Innovation - Clark, New JerseyInside R&I, the
Post Market Safety (PMS) group has direct responsibility for cosmetovigilance and pharmacovigilance operations for the United States, collaborating closely across the Americas Zone.
We are seeking an
Associate Principal Scientist to independently lead technical and process-related activities within the Post-Marketing Safety group. In this pivotal role, you will partner with the Product Safety Evaluation group and other key stakeholders to lead product safety assessments for all over-the-counter (OTC) drug and cosmetic products marketed in the U.S. You will serve as a technical authority, providing direction and supervision to ensure the highest standards of consumer safety and regulatory excellence.
A Day in the Life: As an Associate Principal Scientist in Post Market Safety, your responsibilities will include:
- Medical Assessment & Vigilance: Perform expert medical assessments of adverse event case reports for seriousness, causality, and expectedness, maintaining the integrity of our vigilance operations.
- Global Safety Analysis: Conduct global post-marketing safety analyses requested by cross-functional partners (Marketing, Product Safety, and Global PMS), translating safety data into strategic insights.
- Regulatory Reporting: Lead the quality review and timely submission of all OTC drug and cosmetic MedWatch reports to the FDA, managing correspondence with partner companies and vendors.
- Case Management & Follow-up: Query vendor databases to review adverse events and ensure appropriate follow-up. Notify relevant partner contacts and manufacturing sites of potential quality-related complaints.
- Medical Liaison: Serve as a point of contact for case-related inquiries from the L'Oréal Call Center and Global PMS team. You will also prepare patch test letters and kits for physicians upon request.
- Technical Stewardship: Maintain accurate documentation, recordkeeping, and archiving of all safety-related information in compliance with global SOPs.
- Mentorship & Training: Train and supervise junior members of the PMS team and provide post-marketing safety training for new employees across the organization.
- Process Optimization: Continuously review and update standard operating procedures (SOPs) and work processes to ensure agility and compliance.
We Are Looking For: You are a highly organized medical or pharmaceutical professional with a meticulous eye for detail and a deep understanding of safety regulations.
- Education: Pharm.D., D.Ph., or a Nursing degree is preferred. A working knowledge of basic medical terminology is required.
- Experience:
- Minimum of 7 years of relevant experience in case processing and medical assessment.
- Proficiency in MedDRA coding is required.
- In-depth understanding of U.S. Regulations pertaining to adverse event reporting.
- Skills & Attributes:
- Excellent communication (verbal and written) and interpersonal skills.
- Demonstrated capability in analyzing, reporting, and documenting complex information with strong attention to detail.
- Ability to work independently with minimum supervision in a highly matrixed environment.
- Prior people management experience is a distinct advantage.
- The ability to be onsite, in the office at least 4 days a week, as this is an essential function of the position (required)
- Authorization to work in the United States on a full-time, permanent, ongoing basis without the need for legal sponsorship now or in the future (required)
What's In It For You- A place for you to leave your comfort zone and grow beyond your potential (here, you'll be encouraged to try new things and take risks!)
- Real responsibility from day 1, there's no sitting on the sidelines at L'Oréal
- An environment where people of every ethnicity, social background, age, religion, gender and sexual orientation as well as people with disabilities are accepted, can speak up, will thrive and are celebrated!
- A place where you can contribute to something bigger! Many of our brands have societal /environmental causes to make concrete difference
- Competitive Benefits Package (Medical, Dental, Vision, 401K, Pension Plan)
- Base Salary Range: $107,600 - $153,300 (The actual compensation will depend on a variety of job-related factors which may include geographic location, work experience, education, and skill level)
- Hybrid Work Policy (3 days in Office, up to 2 days Work From Home)
- Flexible Time Off (Paid Company Holidays, Paid Vacation, Vacation Buy Program, Volunteer Time, Summer Fridays & More!)
- Access to Company Perks (VIP Access to L'Oréal's Internal Shop for Discounted Products, Monthly Mobile Allowance)
- Learning and Development Opportunities (Unlimited Access to E-learnings, Lunch & Learn Sessions, Mentorship Programs, & More!)
- Employee Resource Groups (Think Tanks and Innovation Squads)
- Access to Mental Health & Wellness Programs
Don't meet every single requirement? At L'Oréal, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role but your past experience doesn't align perfectly with the qualifications listed in the job description, we encourage you to apply anyways! You may just be the right candidate for this or other roles!
