Johnson & Johnson Careers
Associate Director Medical Affairs
Requisition ID: 8715180802
Johnson & Johnson Consumer Inc. is recruiting an Associate Director-Medical Affairs to be based in Skillman NJ, with occasional trips to Fort Washington PA, and New Brunswick NJ.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Self-Care (OTC), Oral Care, Compromised Skin Care, Baby Care, Beauty, and Feminine Care products.
The Associate Director-Medical Affairs will be responsible for development and implementation of medical strategies and claims support, copy and label reviews, review/approve communications for consumers and healthcare professionals, as well as the operational execution of complex programs and initiatives. In addition to Allergy, this position will also provide scientific contributions to cross-functional project teams supporting a variety of Self-Care and Consumer products and initiatives within assigned therapeutic areas.
The role also serves as a scientific and medical content expert and has a broad range of responsibilities that include developing and prioritizing strategic, tactical, and resource plans for matrixed cross-functional teams. This position requires advanced knowledge in drug metabolism, pharmacokinetics, pharmacodynamics, and clinical trial design and will work closely with colleagues from Clinical Research, Clinical Operations, Regulatory Affairs and Research & Development to ensure quality, timely and coordinated support for both new and marketed products that are compliant with the appropriate company/GCP/ICH and health authority guidelines.
The Associate Director-Medical Affairs position requires skills in in both oral and written communications and is responsible, reviewing study data listings and study reports, leading product claims activities, and contributing to project or company teams when assigned. In addition, this individual will play a role supporting business development activities and will represent the company at appropriate academic, industry, medical, and regulatory meetings.
The Associate Director-Medical Affairs will also be expected to:
- Lead the claims development strategies and implementation for new and marketed products
- Demonstrate expertise in product claims development, protocol development and have significant knowledge in the statistical and clinical interpretation of study results, the ability to understand state-of-the-art computer and mathematical techniques that are used to analyze these types of data, and broad knowledge of regulatory requirements for drug development.
- Demonstrate leadership skills and ability to manage complex processes and initiatives
- Have a proven ability to operate independently, be resourceful and exercise astute business judgment to drive performance.
- Have excellent interpersonal, verbal and written presentation skills. Demonstrated experience in utilizing medical skills for proper segmentation, targeting, and product positioning to successfully drive growth.
- Have strong analytical and qualitative skills and ability to synthesize and integrate data, draw conclusion and implications, and translate into comprehensive strategies and recommendations including preparation of clinical overviews and other medically relevant documents.
- Have the ability to translate strategy into tactics.
- Direct execution of claims development strategy to support new or marketed products
- Ensure all medical affairs activities are conducted in accordance with high ethical/quality standards and all applicable GCP regulations and company procedures
- Participate in and lead medical aspects of safety management team (SMT) activities
- Direct budget management, contract negotiations, and sponsor oversight of all vendor activities
- Assess business development opportunities
- Help explore and evaluate new product ideas to assist in identifying new marketing opportunities
- Evaluate opportunities for continuous improvements that foster innovation
- Evaluate complex human use data including results of clinical trials
- Collaborate in developing responses to Health Authority queries and requests for information
- Maintain awareness of current relevant ICH, FDA, and Industry Guidelines
- Exercise complex level of independent judgment and execution which directly impacts the operational results of the business unit
- Identify, prioritize and manage appropriate resources to successfully achieve strategic medical affairs objectives
- This position requires a minimum of a Master’s Degree with 5 years of medical affairs and/or clinical research-related industry experience OR an advanced degree (PhD, PharmD, MD, DO, or equivalent) with 3 years of medical affairs and/or clinical research-related industry experience.
- Allergy therapeutic are experience and subject matter expertise is preferred.
- Strong technical and business leadership skills are required.
- Must be highly motivated and organized with excellent oral, written communication and presentation skills.
- Must possess ability to independently perform with confidence and deliver results in a timely way, thrive in a changing work environment, effectively function in situations that can have a high degree of ambiguity in a sometimes-pressurized environment while guiding and coaching others on how to do the same.
- The ability to work in a matrix environment with global cross-functional teams is required.
- This position may require up to 10% annual travel (domestic and international).
United States-New Jersey-Skillman
North America-United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)