Key Responsibilities

 

1. 1.       Data Generation 60%

 

New and Current Indications

 

• With regional and global medical affairs colleagues and regional Medical marketing identify and plan key studies required to expand indications and generate data to support the use of key products in these areas.  Identify suitable investigators and facilitate the execution of these studies to ensure that they are conducted to ICH-GCP or ISO14155 guidelines, in compliance with regulatory requirements and in a timely manner, managing contracts with CROs where required.

 

Differentiation / Competitive defence

 

• Manage studies to differentiate products from other treatment choices and competitors. Identify suitable investigators and ensure that studies are conducted to ICH-GCP or ISO 14155 guidelines, in compliance with regulatory requirements and according to timelines required by Global/Regional Marketing.
• Ensure that the study budgets are in line with medical affairs plans.
• Ensure that for any of the company’s sponsored studies any CRO contracted is fully aware of their responsibilities for the timely reporting of study events including but not limited to serious breaches and adverse events to the Pharmacovigilance. Adverse events should also be discussed and documented as part of the routine oversight of CRO activities and included on all study reports.

 

 

1. 2.       Data Dissemination  20%                                                                                                     

New and Current Indications

 

• Ensure that data generated by medical affairs studies are presented at the most appropriate congresses for maximum impact. Produce a plan of which data will be presented at which target congresses and ensure the required submissions are made in collaboration with regional and global marketing teams.

 

Competitive Defence

 

• Working with the Global team, ensure co-ordinated roll out and publication of competitive defence studies to provide maximum utility to sales teams and RSS team.

 

 

1. 3.       VIP Development 10%

 

• Develop and maintain close productive relationships with key customers and opinion leaders by means of consulting, VIP support projects eg data mining/ generation of case study reports or preparation of abstracts and manuscripts.

 

 

1. 4.       Communication 10%

 

• Active and positive contribution to European and Global Teams to ensure that Medical Affairs is aligned to Regional and Global business needs and strategy
• Update senior management with competitive information derived from customer contacts, attendance at congresses, etc.
• Communicate study updates and results to marketing and sales teams as appropriate.
• Maintain central database of studies, publications and investigator payments.  Distribute regular updates to Regional and Global management as requested.
• Provide global team with information relating to relevant studies for quarterly PSUR reports

• Maintain and extend personal expertise in the fields of: Medical by attending congresses, symposia, reviewing market research in these areas and 1:1 contacts with physicians

 

 

PRINCIPAL CHALLENGES

 

• Implement regional study plan for current and emerging indications for Portfolio
• Ensure study results are communicated via congress presentations, publications and sponsored seminars/ symposia
• Cross functional and global alignment

 

CONTACTS

 

• Medical Affairs and Regional Scientific Services Team
• Regional Medical Marketing Team
• Global strategic marketing and R&D
• Global Medical Affairs

 

 

 

 

DESIRED MINIMUM REQUIREMENTS

 

• Life Science Graduate.
• Experience of the set up and management of late phase clinical studies.

 

Essential Skills and abilities

 

• Excellent Communications skills
• Able to critically appraise clinical and scientific proposals and papers
• Ability to build relationships across functions and countries
• Strong customer orientation
• Self starter
• Highly organised
• Able to actively motivate and manage vendors
• Able to meet timelines and budgets
• Mobile and flexible – ability to travel

 

To apply for this vacancy please contact:

Name: Timothy Manning
Telephone: 0208 364 9911
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Please quote reference number: CT2060

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