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.
development, management and execution of IIS strategy, contracts, and budget for
the Consumer sector.
budget is in compliance with Sarbanes-Oxley.
coordination of IIS studies including correspondence with investigators,
researching the investigator site and facilitating review and approval of IIS
leadership and expertise in IIS management and compliance.
with Legal and Health Care Compliance to update company policy and procedures
on IIS to be current with industry best practices.
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
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.
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.
research requests and data analysis for PSUR as determined necessary or
requested by team.
the preparation of ARs, related documents and coordinate comments from medical
writers, clinical scientists and other content contributors.
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.
and assist in implementation of global MA training curriculums.
training compliance records for these activities as required.
and assist with the development and management of contracts and budgets for US
OTC MA projects in collaboration with the project owner.
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.
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.
the development and management of standard operating procedures (SOPs) and
other required compliance documents for Global OTC MA.
as a primary liaison with business and finance personnel to achieve timely
approval and maintenance of contracts and budgets as needed.
of Science in Pharmacy and/or a related scientific field required.
minimum of 5 years in the pharmaceutical and/or related industry required.
technical, scientific and compliance knowledge in operational strategy required.
of policies and regulations relating to IIS and Pharmacovigilance Reports
identify problems and opportunities required.
to handle situations quickly and implement necessary action without hesitation
collaborator across functions, ability to manage upward as well as provide
clear direction to teams required.
and empowers teams to achieve results required.
ownership and accountability for business results and solutions required.
Clinical Research Associate (CRA) desired but not required.
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.
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
- Decisions need to be
made within a complex regulatory and compliance framework required.
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
United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function