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Senior Clinical Affairs & Research Specialist - Southern Africa

Medtronic
Johannesburg, CA 93528
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Senior Clinical Affairs & Research Specialist - Southern Africa

Location:

Johannesburg, Gauteng, South Africa

Requisition #:

19000BZV

Post Date:

Aug 16, 2019


**Careers that Change Lives**


For a specific country or region (several countries
in a same area) the Sr. Clinical Affairs Research Specialist has cross-Businessesresponsibility serving as a local scientific resource and expertengaging with internal (business units and functions) and external
stakeholders (hospitals, physicians, payers)on Scientific Clinical programs.


**ADay in the Life**


TheSr. Clinical Affairs
Research Specialist


+ will develop and manage the local scientificand clinical strategy in full alignment with local market access andtherapy adoption

+ will ensureevidence-based differentiation of our product and therapies

+ has an overview of Scientific and Clinicalprograms andwill provide input onrelevant clinical evidence

+ will support the development of scientificservices and solutions by thoroughly evaluating local market needs, and identifyingknowledge and evidence gaps and unmet needs

+ will design and propose solution and coordinatelocal execution


The following job aspects are specific and
unique for the role:


+ Sr.Clinical Affairs Research Specialist acts as the local Quality,Legal and Compliance gate keeper of Medtronic scientific and Clinicalprograms.


+ Sr. Clinical Affairs Research Specialist manageslocal evidenceplans in light ofmarket needs, changing local environment andcompetitive evidence landscape.


+ Sr. Clinical Affairs Research Specialist worksclosely with other local functions (Reimbursement, Governmental Affairs,Regulatory, IHS, VBHC, Marketing) to support the local market access andtherapy development needs.


+ Sr.Clinical Affairs Research Specialist establishes and maintainsrelationships with leading KOLs, National or Local authorities (decisionmakers) across therapeutic areas


**Relationship Management:**


Actively
builds and maintains optimal relationships with local customers and local Key
Opinion Leaders as well as with local authorities, medical scientific
communities and the medical device industry focusing on the assigned
therapeutic areas.


Represents
Medtronic as theScientific Clinical
face within the country / region and acts at the same time as the voice of
the local organization, customers and authorities towards relevant stakeholders
at Medtronic for the assigned therapeutic areas.


Be
able to navigate into the company matrix and establishing a strategic
partnership with other functions (Compliance, reimbursement, QA, ) and
clinical stakeholders (KOL, Competent authorities) to find the proper solution
to leverage market access/therapy development opportunities.


Is
thefirst point of contact for:


Local customers, authorities
and KOLs about local Clinical matters (ERP, scientific collaboration)


Clinical BU and other
internal stakeholders: for in-depth knowledge about the local clinical
environment and for mandatory consultation on site nomination


**Local/RegionalScientific Clinical Strategy** :


Develops
and manages the local strategy and provides input to the global clinical strategy,
ensuring full alignment with it.


Builds the right level of knowledge in reimbursement, health management
in the country/region to address local/regional needs with relevant clinical
solutions.


Systematically
identifies opportunities for scientific services in the local market and
proposes solutions for those needs.


Systematically
builds an internal and external reputation as a trusted partner in helping
develop and deliver value-based healthcare initiatives, with a focus on outcome
definition and measurement.


**Scientificengagement** **(Enable Study Execution and ERPs)**


Enables
Medtronic sponsored global studies with a focus on local LC, Regulatory
and Finance aspects and ensures study management for local studies.


Is
Point of contact for clinical execution groups at Medtronic as Post Approval
Network (PACS) or MC2 (Medtronic Clinical Operation and Scientific and Study
Solutions) in case of local knowledge needs (language, culture, travel).


Collaborates
with investigators on the ERP submission and follow-up, and locally manages the
support provided by Medtronic (LegalCompliance, Finance and logistics
aspects).


**Local** **Evidence** **Dissemination and Clinical Activities Awareness:**


Ensures
awareness of global and local clinical activities and new clinical evidence and
provides input and training to local organisation.


Advises
local marketing organization on outcome of publications and on a communication
strategy, providingexpert review of marketing / sales presentations,
literature and publications


Ensures
strict adherence to regulations and communicates discrepancies to the different
stakeholders


**JOB QUALIFICATIONS**


KNOWLEDGE/EDUCATION


University Masters or bachelors
degree in relevant technical, clinical or biomedical field


+ Indepth knowledge of local evidence needs and local law regulations


Deep knowledge of the local culture and
language


General knowledge of Good Clinical Practice
and applicable internal and external regulations


JOB
EXPERIENCE


6 Years of relevant
experience in healthcare, scientific or clinical areas is needed


SKILLS


+ Demonstratethe knowledge of local law and regulations

+ Demonstratedability to work effectively on cross-functional teams

+ Demonstratedability to work in a matrix organization

+ Abilitycomfortable to ensure strict adherence to regulations

+ Strongjudgment interpersonal skills

+ Provento be decisive

+ Strongoral and written communication skills in local language and in English

+ Projectmanagement skills

+ Strongbusiness savviness

+ Abilityto multi task to effectively deal with competing business priorities

+ Strongproblem solving influencing skills

+ Customerfocus

+ Abilitydesire to work X-BU

+ Willingto travel extensively in the country / region

+ Abilityto think in the bigger picture and have global perspective


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2019-08-20 Expires: 2020-02-24
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Senior Clinical Affairs & Research Specialist - Southern Africa

Medtronic
Johannesburg, CA 93528

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