Emea Medical Affairs Medical Program Manager Job

Job description

EMEA Medical Affairs Medical Program Manager-00000UEHDescriptionOverall purpose of job:
- To provide Regional Evidence Generation program management leadership for a specified Therapeutic Area or group of Therapeutic Areas within EMEA Medical Affairs (MA) and EMEA HEMAR ensuring all activities are executed in time, in a compliant way and within budget.
- To provide functional line management to the EMEA Medical Program Leads assigned to the corresponding Therapeutic Area(s)
- To serve as the primary contact point for the communication and reporting of Therapeutic Area(s) Program status to internal stakeholders.
- To oversee interactions with internal and external project execution partners to ensure individual projects are conducted to specification, and comply with Company and other quality standards, and are delivered in accordance to specified timelines.
- Develop, grow and maintain relationships with key stakeholders relevant to Evidence Generation projectsMain activities/ tasks:Therapeutic Area Evidence Generation Program Oversight
- Maintain oversight of all Evidence Generation related activities within Medical Affairs and HEMAR EMEA program planning based on ongoing activities & new activities approved during Business Planning exercises and ensure activities are delivered within timelines and budget.
- When no EMPL has been assigned yet to a product with the TA of responsibility, take on EMPL responsibilities (cf EMPL role profile) until an EMPL is assigned.
- Ensure risk mitigation, contingency plans are developed for key activities, checked against available budget and implemented as appropriate by EMPL.
- Responsible for maintenance & update of Program Management systems and quarterly Evidence Generation dashboard for the TA(s) of responsibility.
- Collaborate with EMPD to manage budget planning, tracking and reporting in accordance with finance reporting cycles.
Team Leadership
- Provide functional line management to the EMEA MA Medical Program Leads (EMPL) assigned to the TA of responsibility by setting clear performance objectives, providing feedback and coaching and holding team members accountable for key activities and deliverables.
- Ensure that appropriate trainings related to EMPL role (Medical/Scientific, Functional skills, Study Planning & Execution) are undertaken.
- Conduct regular performance reviews with direct reports to support the personal development and expansion of competencies of Medical Program Leads as a diverse, high performing EMEA medical organisation.
In addition to his Therapeutic Area oversight and Team Leadership, the EMPM will also have project management responsibilities for specific Evidence Generation projects:Data Collection Project Management (Company sponsored studies & Investigator initiated studies), Publications & other activities (advisory boards, Research grants,…)
- Ensure all projects are properly developed, set-up and executed by the Program Management team within timelines & budget.
- For Medical Affairs/HEMAR projects executed by GDO, ensure that GDO-Medical Affairs Operations is aware of EMEA Evidence Generation Program planning.
- Ensure EMEA Publication plans are properly developed and coordinated by the Program Management team within timelines & budget.
Additional Responsibilities
- Represent Evidence Generation for the TA(s) of responsibility to TA leadership meetings (e.g. EMEA Medical Affairs Therapeutic Area meetings, HEMAR meetings,…)
- Collaborate with EMEA Therapeutic Area Leader (ETAL) and EMEA HEMAR Director for the TA(s) of responsibility
- Provide input to continuous improvement of Company Standard Operating Procedures and standards.
Other features of the job:The role involves EMEA and International travel (10-20 %).Job location:The role is EMEA based. The role holder will be expected to be based in their current country of residence as long as easy access to travel/ transportation and local hosting is available in a Janssen office.
QualificationsEssential knowledge & skills:
- Excellent knowledge of study design & execution and related regulations (GCP, European Directives,...).
- Good working knowledge of publication management, benefit/ risk management, real world data, and access programs.
- Leadership, people management and development skills
- Motivated to develop, guide and reward high performance teams
- Highly innovative with the ability to drive multiple projects within a complex and changing environment, and effectively manage and resolve issues within the Program Management Team
- Excellent interpersonal and interdependent partnering skills.
- Strong and demonstrable communication and influencing skills that can impact at a Global and regional level
- Good knowledge of the Johnson & Johnson product range
- Ability to work effectively in a matrix environment, with multi-cultural, virtual teams.
Experience:
- Master degree or higher in a pharmaceutical-related or business subject
- Minimum 8 years experience of industry experience in clinical trial operations, pharmacovigilance, regulatory affairs or quality management.
- Some team leadership or functional line management experience essential with project management experience
- Good understanding of the varying clinical research practices (Phase I to III clinical trials, Post Marketing Data collection activities, Investigator Initiated Activities, ...) and related activities across EMEASpecial requirements:
- Fluency in English language and excellent written English skills essential.
- Fluency in additional EMEA languages an advantage.
Primary Location:Europe/Middle East/AfricaOrganization: Janssen Pharmaceutica N.V. (7555)Job Function: Medical Affairs