Galderma Laboratories, LP
Senior Medical Affairs Manager, Aesthetics (Biotech)
Strategic brands in the U.S. include Epiduo® Gel, Epiduo® Forte Gel, Oracea® Capsules, Clobex® Spray, Mirvaso® Gel, MetroGel® Gel, Soolantra® Cream, Vectical® Cream, Tri-Luma® Cream, Cetaphil®, Differin® Gel OTC, Restylane®, Restylane® Silk, Restylane ® Lyft, Restylane® Refyne, Restylane® Defyne, Dysport® and Sculptra® Aesthetic.
For more information, please visit www.galdermausa.com and www.galderma.com.
Galderma is an equal opportunity employer. M/F/D/V.
The Senior Medical Affairs Manager serves as the internal scientific expert that supports the business unit as representative for a specific Therapeutic area or product. This role acts as the primary medical affairs interface for the dedicated teams (i.e., sales, marketing, and commercial) supporting, coordinating, and implementing projects according to the business unit's needs and specifications and with limited supervision. This position also provides clear and consistent medical and scientific input throughout the late stage development and commercialization phases for all related products/services in the area of expertise. In addition, this role works alongside the Medical Director to define clinical operations and communications strategies to advance science related to products and address gaps in commercial strategy.
• Collaborates with Medical Affairs colleagues to provide day-to-day guidance and assistance in the execution of medical area strategy and tactics with appropriate use of resources
• Participates in appropriate cross-functional and cross-company projects (e.g., clinical trial development, scientific congress/conference planning, advisory boards, publication planning and review, MSL and field force support, medical information standard response letters review, gap analyses, etc.)
• Produces, coordinates, manages and presents medical and scientific content for given medical area (e.g., abstracts, posters, publications, medical decks, speaker programs, advisory boards, educational programs, etc.) including medical and strategic review of all deliverables produced by vendor agencies
• Directs the development of the strategic publication/communication plan in given medical area and stays up-to-date on new data and developments in given medical area
• Identifies, develops, and maintains relationships with scientific influencers; collaborates with scientific influencers and advocacy partners (professional and patient organizations) to learn of customer needs, scientific gaps, trends, opportunities for clinical trials, business development, etc.
• Trains external scientific influencers/MD/PA speakers (and MSLs) on content for medical and promotional events; participates in speaker training programs and work with healthcare professional (HCP) speakers during the development of content for learning programs
• Serves as clinical consultant providing clinical, technical and product knowledge assistance to existing and potential customers; build and maintain solid customer relationships and provide customer training at all levels
• Ensures the integrity of the scientific data used in all promotional claims and materials
• Oversees standardization of publication planning and medical writing processes for Medical Affairs. Provides onboarding and training needs to medical writers and other colleagues, as appropriate, providing a strong understanding of Galderma's medical publication plan and strategy.
• Educates internal and external collaborators on industry standards and GPP
• Other duties as assigned by management
Travel & Residency
Fort Worth, Texas
• Seven or more years of related medical, regulatory affairs and/or research and development experience in the pharmaceutical, biotechnology, medical devices and/or CRO (contract research organization) industry
• Demonstrates the ability to interface effectively with a variety of technical platforms for the collection, review, and dissemination of medical information
• Proficient with MS Office
• Strong understanding of FDA, OIG, HIPAA, and other regulatory guidelines relevant to the pharmaceutical industry; related experience within the United States (i.e. understanding of US regulatory environment)
• Experience within a corporate setting and an understanding of the relationship between marketing/brand teams and medical/regulatory affairs teams is preferred
• Excellent written and verbal communication skills required
• Meeting planning and facilitation skills required
• Strong analytical and organization skills required
• Expertise in relevant medical area ( therapeutic or aesthetic) is required
• Excellent written and verbal communication skills
• Requires strong analytical and organization skills
• Ability to think strategically to guide publication-related activities in accordance with industry standards and good publication practices
• Ability to function in a team-oriented (matrix) environment
• Demonstrable the ability to organize, prioritize, and work effectively in a high-pressure, constantly changing environment
• Ability to develop good relationships and credibility with medical professionals