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Medical Affairs Project Manager

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Job Description



 OVERALL PURPOSE OF JOB:
 

 Medical Affairs Project Management


 • To overview and follow up Medical Affairs data generation activities (including Company Sponsored Studies, Collaborative Studies and IIS) in collaboration with MAF and GCO-MAO, and collaborate with MAF & HEMAR in the coordination of other RWE data collection projects such as third parties’ databases analysis.

• To coordinate compliance activities for Medical Affairs Department.

• To identify process opportunities and design and implement improvement tools.

• In Collaboration with Therapeutic Areas, help to find new ways to collaborate with different stakeholders.

 

 Medical Information


 • To supply medical information in response to internal and external customer enquiries (not expected to handle enquiries from journalists)

• To generate reports including insights and trends

• To challenge status quo and focus on ways of enhancing existing processes

• To keep updated on Immunology Therapeutic Area new challenges, opportunities, main projects and strategy.

 

MAIN ACTIVITIES/TASKS:


 Medical Affairs Project Management

 

·         Have an overview of every project from a financial point of view to foresee potential delays and make needed adjustments.

·         To overview and follow up Medical Affairs data generation activities from planning to publication either traditional or third parties’ databases analysis (including Company Sponsored Studies, Collaborative Studies and IIS), and follow-up the compliance of deadlines established in current laws, regulations, guidelines, procedures and policies and follow-up of main milestones of the project in collaboration with MAF HEMAR (when applicable), and GCO-MAO.

·         Coordinate PRAP for Single Country Company Sponsored studies & IIS protocols and their amendments.

·         Coordinate IISRC: schedule meetings, make documents available to all members, prepare meeting minutes.

·         Track CSR & Publications submissions and request periodic update of Publications report.

·         Have the overview of all planned, on-going, completed, terminated and closed MAF studies in which LOC-OpCo is Sponsor, part of a Cooperative Group or Funding entity, follow-up the compliance of deadlines established in current laws, regulations, guidelines, procedures and policies and with GC-MAO & MAF monitor follow-up of main milestones of the project.

·         Local contact point for the global Clinical Registry team for questions related to local Medical Affairs studies & and ensures Assessment & Disclosure Form is sent to them to assess the need of registry in Clinicaltrials.gov.

·         To coordinate compliance activities for Medical Affairs Department. 

o   Training activities: 

-          To coordinate Face to Face on boarding trainings specific for Medical Affairs  (MAF, Customer Compliance, HCBI, PV, Medical Information, Regulatory Affairs (if needed)).

-          Contact Point for training issues within MAF Department.

-          Maintain local role profiles and training curricula for Medical Affairs therapeutic area roles, if not covered through the global harmonized training curricula.

-          Communicate new role assignments and changes to role assignments in the local Medical Affairs organization to the Medical Affairs Training Support team for all Medical Affairs roles.

-          Contact Regional Team for training on Global IT Systems (Example: RECAP)

o   Perform review of procedural documents, if requested, and provide feedback related to implementation of the Evidence Generation Quality Management System in the local OpCo

·         To coordinate SOP implementations and training regarding MAF activities:

o   Along with Country Medical Director/ Medical Affairs Operations Manager, act as Local Single Point of Contact (SPOC) for project owners for questions related to Medical Affairs Data Generation Activities-related processes and systems.

o   Deep review of applicable SOPs, LIDs and updates and, collaborate with the Country Medical Director for the local implementation of SOPs related to Medical Affairs activities and its documentation in Local Implementation Memo’s/Impact Assessment Forms and Deviation Memos.

o   Collaborate with MAF/MATAL to solve specific issues related to SOPs implementation.

o   In coordination with each line manager, make everyone aware of individual (position based) training needs

·         Help to solve project/ process issues, by working on new ways of approaching projects (new processes or improving existing ones) or by giving support in project issue solving.

·         Other

o   Member of the MACL network

 

Medical Information

 

·         To maintain extensive knowledge of literature resources and continuous contacts with local, national and international information centres, including EMEA SKM, agencies, and other information providers. 

·         To lead the selection of literature for inclusion in medial information enquiries and local standard responses and to be able of the management of foreign technical literature.

·         To keep abreast of current developments in areas of interest to the company and consult with researchers and other information users to maximize usefulness and service.

·         To reply web-based and written enquiries from health care professionals, and internal customers concerning the safe and effective use of all products marketed by Janssen-Cilag in a timely manner.

·         To record all external requests that cannot be recorded directly from the requester or any other different channel, into the CRM database.

·         Systematic follow-up of the pending and open requests.

·         To performs complex information research using electronic and hard copy resources.

·         To search relevant data sources, both internal and external, to identify and retrieve relevant data and information appropriate to answer medical information enquiries.

·         In collaboration with Medical Affairs Managers, to analyse clinical papers to identify appropriate data to answer the medical information enquiries. 

·         In collaboration with Medical Affairs Managers, compile the scientific information for inclusion in standard responses and in response to customer enquiries, maintaining periodic meetings for knowing businesses strategy.

·         To proactively update CRM knowledge database with standard verbal and written responses that can be reused by others in the department to answer medical information enquiries.

·         Generating quarterly reports that include insights, analysing most frequently topics per product and including metrics in response timeliness, adding value to the business and to the activity.

·         Compliance with the Copyright Management - Ensure company´s safety AE/PQC reporting requirements by forwarding any Adverse Event, or other special situation (PQC, drug exposure during pregnancy, lack of efficacy, overdose…) to PV within 24 hours after awareness. Perform reconciliations with the PV Unit on a periodic basis.

 

Additionally, for all employees involved in Research Related Activities (RRAs):

 

·         Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors.

·         Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.

Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description.


Qualifications

ESSENTIAL KNOWLEDGE & SKILLS:  


• Fluent in Spanish and English.

• University Degree preferably Scientific degree: Medical Doctor, Pharmaceutical or Nature Science university degree.

• Deep knowledge and adherence of compliance and procedures, including Johnson & Johnson Credo values, International Health Care Business Integrity Guide and specific Medical Affairs procedures.

• Ability to work with different roles and positions (BQ, Legal, Financial, MAO, PV, MAF, MSL...).

• Organized, methodical and analytical profile. 

• Customer focused with an awareness of the importance of business results.

 

SPECIAL REQUIREMENTS:


• Ability to manage complexity and to prioritize.

• Deep knowledge and adherence of compliance and procedures, including Johnson & Johnson Credo values, International Health Care Business Integrity Guide and specific Medical Affairs procedures.

• Deep knowledge of biomedical databases and health related searching tools. Preferred career development in pharmaceutical industry.


Primary Location
Spain-Community of Madrid-Madrid-
Organization
Janssen-Cilag S.A. (formerly Janssen Sp) (7300)
Job Function
Medical Affairs
Requisition ID
1905787292W