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Vacancy Details

Science Pharmaceutical and Food

Senior Medical Writer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 7/06/2019
Job Reference: 103607
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Senior Medical Writer

Our client, a medical device company in Galway is currently looking to recruit a Senior Medical Writer
for their site.

Job Overview
Responsible for supporting the development and creation of clinical, scientific and regulatory documents in accordance with procedures, European Medical Device Regulations, and US FDA requirements. Also responsible for the maintenance of the related procedures, systems and processes. The primary focus will be on Clinical Evaluation Reports (CERs) and Summaries of Safety and Clinical Performance (SSCPs).

Responsibilities
  • Independently researches, prepares, writes, edits and reviews clinical evidence documents, e.g. CERs and SSCPs.
  • Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.
  • Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.
  • Manages and maintains the procedures, systems and processes required to meet regulatory requirements for clinical evidence documents and ensures they stay up-to-date based on guidance, regulation and feedback from regulators.
  • Collaborates with cross-functional teams to ensure high quality and successful project delivery.
  • Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents.
  • Provides input to post-market surveillance and risk management activities.
  • Creates and manages schedule of deliverables.
  • Conducts training for medical writers, regulatory affairs and other functions, as needed.
  • May supervise or mentor other medical writers, as assigned.
  • Performs other duties and tasks, as required.


Qualifications/Competencies
  • Demonstrate organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.
  • Education and/or experience equivalent to a Bachelor's Degree in the medical, biological, physical or engineering disciplines and five years of medical writing experience, preferably with CERs.
  • Extensive knowledge of regulatory requirements relative to Clinical Evaluation Reports.
  • Proficient in searching medical literature and databases for clinical and technical information.
  • Ability to read, analyse, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information and complex documents.
  • Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), EU Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards.
  • Effective written and verbal communication skills in the area of technical/clinical applications.
  • Supervisory experience.
  • Strong command of medical and surgical terminology.
  • Working knowledge of statistics.
  • Self-motivated, self-directing, strong attention to detail and excellent time management skills.
  • Project management skills.
  • Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs.

For further information on this Senior Medical Writer role in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval


Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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Clients we are proud to work with

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