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Medical Affairs

Medical Affairs Therapeutic Area Lead Actelion

Locations: Beerse, Belgium
Functions: Medical Affairs
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Job Description

Requisition ID: 1905710878W

Function description
Medical Affairs Therapeutic Area Lead is the medical leader within the assigned therapeutic area (TA) and manages the TA's Medical Affairs team. Acts as the proactive strategic partner within the Cluster Value Team (CVT) for medical excellence in his/her assigned TA. In this role the Medical Affairs Therapeutic Area Lead acts as a bridge between the Benelux and the EMEA Medical Affairs organization in building the CVT's strategy and providing Benelux level insights for the EMEA Medical Affairs strategy.

Place in the organization
The Medical Affairs Therapeutic Area Lead reports to the the Medical Director Benelux, who is a member of the Management Board. The Medical Affairs Therapeutic Area Lead has people management responsibilities, leading one (or more) Medical Advisors (MAs) and Medical Science Liaisons (MSLs). The Medical Affairs Therapeutic Area Lead is the scientific partner to the business, thus supporting the overall company business goals. The Medical Affairs Therapeutic Area Lead is expected to lead changes in organizational behaviors to successfully implement a medical deployment for a specific therapeutic area in line with the Cluster Value Team's expectations.

The function of Medical Affairs Therapeutic Area Lead contains the following main tasks & responsibilities:
* Shape CVT Planning & Strategy, based upon medical insights and data gathered in the field
* Translate information and insights of the relevant TA treatment framework from internal and
external stakeholders into strategy and plan for implementation
* Build a wide network internally and thus contribute to multi-disciplinary (research & development, marketing, health economics/market access/reimbursement (HEMAR)) strategies
* Proactively explore needs for evidence generation, make strategic choices for delivery of evidence (outcomes, methods, internal & external collaborations) and apply insights for new
value propositions for the therapeutic area and the business
* Take on role of Study Responsible Physician/Scientist (SRP/SRS) where applicable
* Represent the full medical domain (including Q&C, RA, PV, QA, Medical Information) within the CVT for his/her TA
* Ensure that CVT strategy is aligned with regional (EMEA) and adapted in the local strategy

Develop and ensure execution of MAF contribution to CVT strategic plan
* Responsible for the management of the Benelux TA Medical Affairs (MAF) team and the delivery on target
* Responsible for continuous learning programs internally
* Shape the CVT strategic plan in line with the overall MAF strategy.
* Implement activities and measure performance based upon the predefinied KPIs and matrix of Medical Affairs
* Discuss and align the Medical Affairs contribution to the CVT plan, EMEA Medical Affairs Functional Network and MAF mission and priorities
* Manage MAF budget for his/her TA, including resource allocation
* Take personal actions to ensure that medical affairs function is a valued partner of commercial teams through effective internal communication, participation in senior management meetings, engagement and promotion of medical contributions
* Ensure high quality medical input is provided to regional brand teams to ensure appropriate strategies are developed for the region

Build & maintain TA leadership and stakeholder network
* Build and maintain a strategic overview of the external health care environment
* Build an external network as a strategic representative to external bodies
* Keep abreast of medical and scientific knowledge
* Continuously update knowledge of products, patient treatment trends and clinical activities and studies within the TA and patient treatment trends in the region
* Identify evolving scientific concepts with future clinical implications
* Considered and recognized as a trusted scientific counterpart and a partner
* Ensure medical quality & consistency
* Final responsibility for the quality and consistency of medical content within TA
* Ensure the correct use of products within his/her TA

Ensure team compliance
* Maintain compliance with local and EMEA standard operating procedures (SOPs); document training and maintain personal binder according to SOPs
* Ensure compliance with regulatory requirements and with company policy on business integrity
* Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOP's (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors
* Ensure HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.

Qualifications

For the function Medical Affairs Therapeutic Area Lead the following qualifications are required:
* Scientific degree: Medical Doctor, pharmaceutical or biomedical degree or equivalent by experience
* More than 4 years experience within Medical Affairs in the pharmaceutical industry
* Experience in managing the organization and business operation in the division/department
* Proven strong analytical, communication, influencing, decision-making and leadership skills for interaction with external and internal stakeholders
* Deep understanding of local regulatory policy and industry's code of practice related to drug registration, pharmaceutical promotion and clinical studies
* Conceptual skills: able to have an integral view across different disciplines within the medical domain for the therapeutic area
* Able to represent the medical domain in its broadest sense (including Medical Education, Regulatory Affairs (RA), Pharmacovigilance (PV), Quality Affairs (QA); an orchestrator beside being an expert in his/her field
* People management and team leadership skills: stimulate and motivate to develop and execute medical excellence and medical leadership
* Conceptual skills: able to have an integral view across different disciplines within the medical domain for the therapeutic area
* Languages: Dutch, English: spoken & written; notion of French

For the function Medical Affairs Therapeutic Area Lead the following qualifications are preferred:
* Experience in managing professionals in the pharmaceutical or related industries
* Preferred Business acumen and relevant experience/ training in business administration for translation into strategy
* Knowledge of the therapeutic area
* Understanding of Clinical Study operations and execution is preferred

Leadership & Management Behavioral Competencies:
* Leadership: Leading and implementing a high level of medical integrity and health care compliance within his/her therapeutic area. Medical leadership: shape and optimize treatment and treatment paradigm both within the organization and outside in the broader market place, in particular in the aera of personalized medicine and targeted therapies.
* Strategic Thinking: Thinking strategically to translate medical/clinical insights of treatment paradigms into growth opportunities, process improvement and driving competitive advantage
* Decision Making: Keen ability to make practical, realistic, fact-based, thoughtful and timely decisions while building a collaborative culture
* People Management & Team Leadership Skills: Stimulate and motivate to develop and execute medical excellence and medical leadership
* Customer Focus: Identify opportunities and take action to build strong scientifically based relationships; able to gather and represent professional views, partners with customers, internal stakeholders including the business related functions
* Result Oriented: Defines ambitious goals and establishes priorities with clear responsibilities to ensure results; manages projects, activities and resources effectively

Personal Characteristics talents:
* Team player. Strong in decision making. Stimulating and
contributing to the development of team members
* Ability to work in a matrix environment
* Ability to work independently as a hands-on manager, and
proactively contribute as a resource when necessary
* Flexibility to adapt and meet the changing/growing needs of
our customers
* Get energy from solving issues in a constructive and an
innovative approach
* High level of integrity, compliance, ethics and transparencyFlexibility to adapt and meet the changing/growing needs of
our customers
* Get energy from solving issues in a constructive and an
innovative approach
* High level of integrity, compliance, ethics and transparency

What's in it for you…?
"Caring for the world, one person at a time…"
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Cilag N.V./S.A. (7025)
Job Function
Medical Affairs
Requisition ID
1905710878W
Pharmaceuticals

Medical Affairs

Permanent contract