Associate Manager, Medical Affairs
Location:
Fort Washington , Pennsylvania
Posted:
February 03, 2017
Reference:
5029170115-en-us

Johnson & Johnson Consumer Inc., is hiring an  in Fort Washington, PA.

 

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: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

 

The Associate Manager, Medical Affairs will:

  • Under the general supervision of the Director, Medical Affairs, this person manages IIS process and safety reporting across the Consumer Group globally. 
  • Develops the strategy and management of US OTC investigator initiated studies.
  • Ensures compliance with the review, funding, execution, reporting and closeout of all IIS. 
  • Manages the Clinical/Medical Affairs/Toxicology process for Aggregate Safety Reporting and Safety Management Teams for the Consumer sector for the Consumer portfolio of products. 
  • Coordinates the development and management of standard operating procedures (SOPs) and other required compliance documents for Global OTC MA
  • Manages contracts and budgets for US OTC MA.
  • Oversee development, management and execution of IIS strategy, contracts, and budget for the Consumer sector.
  • Ensure budget is in compliance with Sarbanes-Oxley. 
  • Oversee coordination of IIS studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals.
  • Provide leadership and expertise in IIS management and compliance.
  • Liaise with Legal and Health Care Compliance to update company policy and procedures on IIS to be current with industry best practices.
  • Ensure compliance with the review, funding, execution, reporting and closeout of all IIS. This includes but is not limited to:  creation of process and template documents, compliance with regulatory requirements and Standard Operating Procedures (SOPs), company training and modifying process as appropriate based on the impact of emerging regulations on procedures.
  • Oversee the Clinical/Medical Affairs/Toxicology Aggregate Report (AR) process for the Consumer sector for the Consumer portfolio of products.  This includes but is not limited to:  creation of process and template documents, negotiation of timelines, assignment of AR requests, compliance with the worldwide regulatory requirements and Standard Operating Procedures (SOPs), company training and modifying process as appropriate based on the impact of emerging regulations on procedures. 
  • Provide technical/medical writing support to the medical writers, clinical scientists and other content experts contributing content to ACOs, PSURs, Annual Reports and Safety Management Team CFIs.
  • Gather/perform research requests and data analysis for PSUR as determined necessary or requested by team. 
  • Facilitate the preparation of ARs, related documents and coordinate comments from medical writers, clinical scientists and other content contributors.
  • Identify training requirements or needs, coordinate development of training curricula, and assign the appropriate training and education curricula to all US OTC MA personnel as required to maintain each role’s core competency and compliance.
  • Design and assist in implementation of global MA training curriculums.
  • Maintain training compliance records for these activities as required. 
  • Coordinate and assist with the development and management of contracts and budgets for US OTC MA projects in collaboration with the project owner.

  • Serve as main point of contact with cross functional business partners for testing and implementation of systems related to IIS, Medical Education Grants, Advisory Boards, Sponsorships and other HCP contracting transactions.

  • Will act as a primary coordinator of internal subject matter experts and other personnel as needed to achieve timely development, approval and maintenance of SOPs and related documents.

  • Coordinate the development and management of standard operating procedures (SOPs) and other required compliance documents for Global OTC MA.

  • Act as a primary liaison with business and finance personnel to achieve timely approval and maintenance of contracts and budgets as needed. 


Qualifications

  • Bachelors of Science in Pharmacy and/or a related scientific field required.
  • Advanced degree preferred.
  • A minimum of 5 years in the pharmaceutical and/or related industry required.
  • Advanced technical, scientific and compliance knowledge in operational strategy required.
  • Understanding of policies and regulations relating to IIS and Pharmacovigilance Reports preferred.
  • Proactively identify problems and opportunities required. 
  • Ability to handle situations quickly and implement necessary action without hesitation required. 
  • Strong collaborator across functions, ability to manage upward as well as provide clear direction to teams required.
  • Motivates and empowers teams to achieve results required.
  • Assumes ownership and accountability for business results and solutions required.
  • Certified Clinical Research Associate (CRA) desired but not required.
  • Must possess the following competencies: LEAD, SHAPE, CONNECT and DELIVER.  Within these competencies, it is critical that this individual have the ability to collaborate, understand diverse viewpoints, develop mutually agreeable solutions and see them through to conclusion in a matrixed environment also required.
  • Strong work ethic and ability to effectively balance multiple demands, as well as develop and maintain focus in a changing environment required.
  • High level of decision-making and solutions-oriented complexity, balancing the opportunities and risks of new concepts or approaches to achieve a goal, and alignment with business priorities required
  • Prioritization of decisions must balance needs of multiple stakeholders, and be flexible in their execution required.
  • Decisions need to be made within a complex regulatory and compliance framework required.
  • Innovative/creative skills that enhance the efficiency and effectiveness of assigned activities and projects. The position will require competencies in project management, strategic planning, communication and public speaking, computer skills, interpersonal skills, and networking required.
  • Up to 15% travel (domestic) required.


Primary Location
United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Medical Affairs

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.