About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significate growth for Abbott in COVID-19 related products in over 70+ countries.

PURPOSE OF THE JOB:

To accomplish primary goal of communicating complex medical information in clear and compliant writing. The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, synopses, regulatory documents, Clinical Study Report (CSR), clinical publications, and related clinical documents within agreed-upon timelines.

MAJOR RESPONSIBILITIES

• Prepares, edits, and finalizes protocols, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts

•  Participates in scientific communication planning, including development of strategic medical communication plans

• Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
• Works closely with the Clinical Scientists and Clinical Operations team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
• Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Collaborates with clinical scientists, biostatisticians, and Medical expert to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Manages the document review process according to QMS
• Works closely with the study team to reach consensus on timelines for deliverables
• Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
•  Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
• Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
•  Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
• Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
• Align with department management to set strategy for meeting department goals

EDUCATION & COMPETENCIES:

• At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred
• Bachelor’s degree +7 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical, IVD or Device industry
• An understanding of the drug development process
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
• Experienced in writing in accordance with regulations, standards, and guidelines, must meet ICH, GLPs, and GCPs guidelines
• Ability to work with cross-functional project teams. Ability to coordinate multiple tasks, and manage priorities.
• Strong communication and writing skills. Strong analytical and problem solving skills.
• Excellent organizational time management skills
• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail. 

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.