Director, Medical Safety Officer, Oncology

3 weeks ago

Horsham, United States Johnson & Johnson Full time

Johnson & Johnson, is recruiting for a Director, Medical Safety Officer, Oncology to be located in Horsham, PA; Titusville, NJ; or Raritan, NJ.

We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo.

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

The Pharmaceuticals Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Johnson & Johnson products and will strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.

The MSO will report to the GMS Sr. Director Product Safety Head, Oncology and oversee the safety and benefit/risk assessment of assigned products within the Oncology TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit-risk assessment of assigned products within the TA. The MSO will communicate potential and known risks and changes to benefit/risk, when appropriate, to the Sr. Director Product Safety Head, the VP Therapeutic Area Safety Head (TASH), the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Johnson & Johnson products.

**Responsibilities include, but are not limited to the following**:

- Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS), as well as other activities related to managing the safety profile of assigned products (e.g., Program Safety Analysis Plan)
- Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams
- Anticipate safety concerns and influence other relevant functions including Clinical and Medical Affairs teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.
- Be an active partner and core contributor of safety input to key regulatory or clinical documents including:

- Risk management plans
- Clinical Trial, EAP and IIS Protocols
- Informed Consent Forms (ICF), including Risk Language
- Safety Sections of Investigator’s Brochure (IB) and IB addenda
- Safety sections of Clinical Study Reports (CSR)
- Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings
- Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR), Development Safety Update Report (DSUR)
- Health authority queries
- Company Core Data Sheets (CCDS), US and EU prescribing information
- Signal Evaluations
- Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations when necessary, to the GMS Leadership Team, CMO, and the Pharmaceuticals Medical Safety Council (MSC)
- Actively participate and contribute to meetings with Health Authorities and external key opinion leaders
- Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities
- Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products. This will include:

- Defining the safety question or issue requiring medical safety assessment
- Developing the strategy for the safety review and analysis
- Interpreting results and determining the medical importance of question or issue
- Reviewing and approving (i.e., signatory) medical assessment reports, e.g. ad hoc safety reports
- Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues
- Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management
- Lead or actively participate in department-wide initiatives

**Qualifications**:
**Education and Experience**:

- Physician (MD or equivalent) with a minimum of 2 years of pharmacovigilance experience or other rele

  • Director, Safety Surveillance Physician

    3 weeks ago

    Horsham, United States Johnson & Johnson Full time

    Johnson & Johnson, is recruiting for a **Director, Safety Surveillance Physician (Oncology) **to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA. We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo. Thriving on a diverse company...

  • Director, Medical Safety Officer, Neuroscience and Ophthalmology

    3 weeks ago

    Horsham, Pennsylvania, United States J&J Family of Companies Full time

    Director, Medical Safety Officer, Neuroscience and Ophthalmology at Johnson & JohnsonDescriptionJohnson & Johnson is currently hiring for a Director, Medical Safety Officer, specializing in Neuroscience and Ophthalmology. This position can be based in Titusville, NJ; Raritan, NJ; or Horsham, PA.At Johnson & Johnson, we are dedicated to advancing healthcare...

  • Director, Safety Surveillance Physician

    1 month ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Johnson & Johnson, is recruiting for a Director, Safety Surveillance Physician (Oncology) to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter...

  • Associate Director, Oncology Learning

    3 weeks ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Job Description Janssen Scientific Affairs is recruiting for an Associate Director, Oncology Learning & Development – Solid Tumor, located in Horsham, PA. The Associate Director, Oncology Learning & Development – Solid Tumor will serve as a strategic partner to support training needs and priorities for the Medical Affairs (MA) organization in solid...

  • Senior Director, Oncology Key Accounts

    1 month ago

    Horsham, United States Johnson & Johnson Full time

    Johnson & Johnson, is recruiting for the Senior Director, Oncology Key Accounts, located in Horsham, PA. We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. For more than 30 years, Johnson & Johnson has delivered on the promise of new treatments and ways to improve the...

  • Senior Director, Oncology Key Accounts

    3 weeks ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Job Description Johnson & Johnson, is recruiting for the Senior Director, Oncology Key Accounts, located in Horsham, PA. We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. For more than 30 years, Johnson & Johnson has delivered on the promise of new treatments and ways to...

  • Senior Director, Oncology Key Accounts

    3 weeks ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Johnson & Johnson, is recruiting for the Senior Director, Oncology Key Accounts, located in Horsham, PA.We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. For more than 30 years, Johnson & Johnson has delivered on the promise of new treatments and ways to improve the...

  • Associate Director, Oncology Learning

    2 months ago

    Horsham, United States Johnson & Johnson Full time

    Janssen Scientific Affairs is recruiting for an Associate Director, Oncology Learning & Development - Solid Tumor, located in Horsham, PA. The Associate Director, Oncology Learning & Development - Solid Tumor will serve as a strategic partner to support training needs and priorities for the Medical Affairs (MA) organization in solid tumor. This role will...

  • Associate Director, Field Access

    1 month ago

    Horsham, United States Johnson & Johnson Full time

    Associate Director, Field Access & Affordability Solutions Oncology About Us At Johnson & Johnson Innovative Medicine (JJIM), what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might...

  • Associate Director, Clinical Project Scientist

    3 weeks ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Johnson & Johnson, is recruiting for an Associate Director, Clinical Project Scientist, Oncology to be located in Horsham, PA.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and...

  • Associate Director, Program Management

    2 months ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director Program Management, Oncology to be located in Horsham, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways...

  • Associate Director, Omnichannel Strategy and Execution, Oncology

    2 weeks ago

    Horsham, United States Johnson & Johnson Full time

    DescriptionJohnson & Johnson Innovative Medicine is recruiting for an Associate Director, Omnichannel Strategy and Execution, Oncology located in Horsham, PA or Titusville, NJ.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured,...

  • Product Director

    1 month ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Johnson & Johnson is currently recruiting for a Product Director, Professional Promotion, DARZALEX located in Horsham, PA. At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,...

  • Ad, Safety Analysis Scientist

    2 weeks ago

    Horsham, United States Johnson & Johnson Full time

    Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision. - Ensure high quality safety evaluations and reports with mínimal comments from stakeholders and mínimal revisions required. - Provide...

  • Associate Director, Medical Communications

    3 weeks ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Johnson & Johnson is recruiting for an Associate Director, Medical Communications, Dermatology Therapeutic Area in our US Medical Affairs organization located in Horsham, Pennsylvania.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in...

  • Manager, Safety Analysis Scientist

    3 weeks ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    The Manager Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The Manager SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related...

  • Associate Director, Immunology Medical Affairs Data

    2 weeks ago

    Horsham, United States Johnson & Johnson Full time

    Johnson and Johnson Inc. is hiring an Associate Director, Immunology Medical Affairs Data Analytics. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company. The Associate Director, Immunology Medical Affairs Data Analytics role is responsible for generating, integrating and translating insights to...

  • Global Medical Affairs Leader, Director, Dermatology

    2 months ago

    Horsham, United States Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine, Immunology Global Medical Affairs, is recruiting for a Global Medical Affairs Leader (GMAL), Director, Dermatology, located in Horsham, Pennsylvania or Spring House, Pennsylvania. The Global Medical Affairs Leader (GMAL), Director, Dermatology, under the direction of the Head of Global Medical Affairs for Dermatology,...

  • Specialist 3 - Medical Affairs

    1 month ago

    Horsham, United States Pioneer Data Systems Full time

    Position Details: Our client, a world-leading Pharmaceutical Company in Horsham, PA is currently looking for a Clinical Data Specialist to join their expanding team. Job Title: Clinical Data Specialist / Medidata Rave / Hybrid Work Duration: 6 months contract, extendable up to 24 months Location: Horsham, PA Hybrid Work: 2-3...

  • Medical Director, Rheumatology Therapeutic Area

    3 weeks ago

    Horsham, Pennsylvania, United States Johnson & Johnson Full time

    Job Description Johnson and Johnson is recruiting for a Medical Director, Rheumatology Therapeutic Area in our US Immunology Medical Affairs organization located in Horsham, PA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured,...