DirecciónEstablished Products Clinical & MedicalAffairs Associate Director - 2406171854W
Description
Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for an Established Products (EP) Clinical & Medical Affairs Associate Director (CMAAD) located in Titusville, New Jersey; Toronto, Canada; Beerse, Belgium; Leiden, Netherlands; High Wycombe, UK; Lisbon, Portugal; Madrid, Spain; Issy-Moulin, France; Neuss, Germany; Milan, Italy; Bogota, Columbia; Sao Paolo, Brazil.
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 solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .
The EP CMAAD is a member of the EP Global Medical Affairs Group leading certain aspects of the medical-commercial optimization for products in the market and late lifecycle management strategies and plans. The EP CMAAD will partner with GMA Operations, Regional Medical TA/product/portfolio leaders, and Clinical Development Leaders to support developing and implementing integrated global Medical Affairs perspectives, strategies, and plans.
The EP CMAAD also supports the Therapeutic Area (TA) Portfolio Clinical Leader Team and is dedicated to maximizing the value of this portfolio through the execution of all phases of clinical development and in particular, provides active medical and scientific contribution to cross-functional clinical teams to support the successful completion of clinical projects and deliverables that enable worldwide registrations for new indications, enhancements to the label and compliance with regulatory commitments for products in the market and in development.
Clinical Responsibilities:
Acting in concert with senior clinical personnel as a company spokesperson regarding publication of clinical research findings and presentations to relevant FDA, EMA, or other Health Authorities (HA), advisory committees, and review meetings (e.g., pre-NDA meetings).
Acting as a liaison between our company and investigators and develops relationships with opinion leaders and key regulatory officials.
Working with the GLT, Regulatory Affairs and Global Medical Safety (GMS) to update the Company Core Data Sheets (CCDS), Summary of Product Characteristic (SmPCs), United States Prescribing Information (USPIs), and other local labels for products in the portfolio.
Leading Clinical Teams in the fulfillment of Phase IV commitments and other projects as required by regulatory authorities.
Collaborating with international teams on responses to requests from HAs, worldwide; Phase-3 registration studies conducted by operating companies; and timely implementations of corrective actions as needed.
Executing clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications. The EP CMAAD leads teams in preparing development plans, protocols, Clinical Study Reports (CSRs), and documents for regulatory filings. The EP CMAAD is responsible for medical monitoring and safety reporting of clinical studies.
Participating in cross-functional teams for evaluation of new product ideas, reviews medical literature, and related new technologies.
Providing active medical and managerial leadership for the operational implementation and execution of clinical programs through matrix management of cross-functional teams. Medical and scientific problems are discussed and solved within teams.
Medical Affairs Responsibilities:
Lead the development of the Global Medical Affairs (GMAF) strategy and plan for the assigned compounds based on prioritized regional needs.
Collaborate with the Compound Development Team(s) (CDT) to ensure integration with the overall global compound product strategy position, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing Medical Affairs global and regional value needs.
Lead/participate in the MAST(s), consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one Medical Affairs perspective and one “unified” voice on the CDT.
Collaborate closely with the regional Medical Affairs representatives to develop integrated global Medical Affairs strategies and plans and maintain open, two-way communication to ensure regional Medical Affairs is up to date on all plans, progress and decisions.
Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.
Lead development and execution of the global publication plan as well as review and approval of publications and scientific congress displays for marketed products and specified compounds in clinical development to ensure alignment with strategy and effective communication /presentation with internal and external audiences.
Lead pre- and post-launch medical activities including product/therapeutic area global advisory boards, medical education symposia and congress activities, coordination of regional activity in these areas.
Reviewing the Medical Information Core Responses for products still supported by medical information If a medical information inquiry is escalated to the global level: Co-ordinate and facilitate a timely and scientifically accurate response.
Manage the ReCAP (review of all Medical Affairs sponsored clinical trials and Investigator Initiated Sponsored studies) and JPUBS (review of publications and congress materials) processes for applicable products.
Perform Medical Impact Assessments as required and coordinate internal Medical Affairs training and support in the use of EP specific tools, like the Product Portfolio Assessment (PPA) tool.
Support development of the company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds.
Lead relevant patient advocacy initiatives and strategy by driving, building and enhancing strategic alliances with key national and international stakeholders, including patient advocacy groups, physician advocacy groups, academic organizations and other relevant stakeholders in response to patient needs and in support of Janssen’s global patient advocacy objectives and related strategic goals responsibility for Janssen’s patient advocacy landscape assessment and engagement strategy.
Represent the EP GMAL, as needed, as a member of product SMTs, CDTs Labelling Working Group (LWG) and Global Commercial Team(s) (GCT) and in review and creation of various HA responses and Regulatory Affairs and safety documents such as clinical overviews or Periodic Safety Update Reports (PSURs).
Collaborate closely with CDT commercial representatives and external partners as needed/appropriate.
Provide medical input into market research and health outcomes research conducted by commercial and market access teams, respectively.
Ensure all global Medical Affairs activities follow J&J compliance principles (e.g., Health Care Compliance).
Support to internal/external talent development initiatives representing Medical Affairs functional area as appropriate.
Qualifications
Scientific or Medical degree is required.
A minimum of 8 years of combined experience and advanced medical education in drug development, medical/clinical environment and/or scientific function in the pharmaceutical industry and/or academia is preferred
Experience in Medical Affairs is highly preferred
Outstanding oral and written communication skills (including reports development and communication of scientific data to internal and external audiences) are required
Success working in a matrix environment a strongly preferred
Candidate should possess strong problem-solving skills for developing creative solutions and meeting project objectives.
Candidate should have demonstrated ability of strategic thinking and contingency planning with respect to portfolio objectives.
A global mindset and ability to partner cross-culturally/regionally is required.
This position may require up to 25% annual travel
The anticipated base pay range for this position is $135,000 US - $232,300 US.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits: - Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
This job posting is anticipated to close on March 22, 2024. The Company may however extend this time-period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location NA-US-New Jersey-Titusville
Other Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Spain-Community of Madrid-Madrid, Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss, NA-CA-Ontario-Toronto, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Latin America-Colombia-Distrito Capital de Bogotá-Bogotá, Europe/Middle East/Africa-Portugal-Lisbon-Lisbon, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux, Latin America-Brazil-São Paulo, Europe/Middle East/Africa-Italy-Milano
Organization Janssen Research & Development, LLC (6084)
Travel Yes, 25 % of the Time
Job FunctionMedical Affairs & Marketed Products
Req ID: 2406171854W
