HireDiversity

Latin America-Mexico-Distrito Federal

MEDICAL FIELD PROJECT LEADER-000008GH

Description

MEDICAL FIELD PROJECT LEADER 000008GH

"Johnson & Johnson companies are equal opportunity employers"

The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time. Our people, across many different companies, are united in their passionate pursuit of science for the benefit of patients. With employees in over 50 countries, we share the commitment of our corporate parents to bring innovative ideas, products and services to patients throughout the world.

Description:
PML is mainly responsible for make teams successful by providing strategic and operational leadership:

• to support the flawless implementation of the Medical & Regulatory Affairs strategies and plans

• to enable proactive end-to-end time, scope, and resource management for MAF and functional teams via (Program Management Team) PMTs
• to identify and manage project risk by removing failure modes and mitigating obstacles

Main Responsibilities:

To coordinate, compile, and submit new drug applications, variations and renewals of assigned products to the regulatory agency at LOC/Cluster level under the supervision and strategic guidance of the Regulatory Affairs Sr. Manager at the LOC, for granting new marketing authorizations and maintenance the assigned products registry aligned to the local operating company objectives by:
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Organizes and maintains reporting schedules for new drug application, variations and renewal of assigned products.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Provides solutions to a variety of problems of moderate scope of complexity.
- Conducts searches of existing files for requested information.
- Maintains and archives all regulatory documentation.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides regulatory advice to assigned project teams.

Assists with the preparation and update of standard operations

Responsibilities:

The following processes and activities fall under the direct responsibilities of this position:

PML make functions successful by providing:

• links between project & therapeutic areas priorities and resource capacity

• functional team planning and facilitation of resource capacity management

• functional decision support at multiple levels

PML make Medical Affairs & Regulatory Affairs governance successful by providing:

• relevant and reliable analyses & interpretive insights and recommendations

• timely & high quality Medical Affairs decision support to diverse stakeholder groups

• documentation and communication of decisions to all stakeholders

Is responsible for leading the cross functional operations of MAF projects/programs within the therapeutic area by managing project scope, timelines, budgets and risk:
- MAF & Logistic events interaction
- MAF & RA interaction
- MAF & Marketing
- MAF & Access team interaction
- MAF & GCO interaction

Is responsible for day-to-day operations of the Project Manger Leader Assistant, and works closely with the Medical Manager to ensure that Continual Medical Education operations are conducted according to plan.

Work together with local Medical Manager level to coordinate and drive the implementation of Medical Education Plan for the product/therapeutic area:
- Ensure all programs are in compliance with regulatory HCC and legal guidelines, and company polices( maintain a complete documentation related to HCC submission and post event)
- Negotiate contracts, review budgets, allocate resources and monitor expenses for the Medical Education activities
- Have a significant role in Sharepoint (CME, HIT, SEVEN, SISCA) site coordination and follow up, Management Essentials, and team governance activities.
- Analyze achievement of measurement milestones (Key performance indicators)

Play a key role in organizing department and team meetings and logistics.

Implement the Health Care Compliance International Framework and Compliance Guide, focusing on Health Care Compliance aspects related to Medical Affairs activities, and assure high compliance to Standard Policies, Procedures, and Regulatory Affairs.

Ensure a high quality, regular review and updating of Standard Operating Procedures and appropriate sign-off, distribution and management process for these documents.
- Review and distribute local Medical Education statistics/feedback to MAF & RA team to provide insights into market trend and issues
- Build internal reputation as a credible Medical Education expert and advocate
Continuously update knowledge of market trends and competitor activities, and of new developments and industry best practices in Medical Education

Capabilities:
Strategic and operational decision support to optimize MAF & RA investments and balance project/ portfolio risk

• Independent and objective analyses to influence process improvements and change management

• Management of project/program scope, time, resources, risk and quality

• Development/leadership of high performing teams to bring focus and accelerate key decisions

• Collection and information management of project and resource data

Qualifications


Requirements: Industrial Engineer, Business Administration, Chemistry with previous experience as senior project manager or senior academic degree and oral and written fluency in english

LEADERSHIP COMPETENCIES REQUIRED:

Integrity and Credo-based Actions: lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people

Strategic Thinking: driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; motivated to leave things

better than they were; a change agent

Big Picture Orientation with Attention to Detail: able to operate in two "worlds" simultaneously. I.e. growth and cost control, enterprise and operating company success;

sees the why as well as the what; can zoom in or out as needed

Collaboration and Teaming: puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires followership; instills a

global mindset; champions best practices

Sense of Urgency: proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed

Prudent Risk-taking: inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses; willing to make tough

integrated Logistics Support Planning.

Submit your resume by:

Job:000008GH

Primary Location: México DF

Recruiter: Juan Pablo Reynaud

Paid Grade: 25

Organization: 7250 Janssen Farmacéutica
Relocation: : The Company won't be responsable for posible relocation or permanent expenses, or work permits for this position.

Primary Location:Latin America-Mexico-Distrito Federal
Organization: Janssen de México, S. de R.L. de C.V. (7250)
Relocation: Eligible
No
Travel:No
Job Function: Regulatory Affairs