What are the responsibilities and job description for the Sr Medical Writer position at Integrated Resources, Inc ( IRI )?
Sr Medical Writer/Sr. Publications Specialist
HM's Top 3:
Years’ Experience Required: 4 years medical writing or related field (or 2 years with advanced degree)
40 hours per week
Onsite Preferred
The publications team, a part of the CRM Clinical Research and Medical Affairs Team, is responsible for managing the publications process and supports global evidence dissemination from Medtronic-sponsored clinical trials, registries, and other research data. Publication professionals in this role work closely with Principal Investigators and internal team members from the clinical study team, statistics, clinical leadership and cross-functional SMEs.
The Senior Publications Specialist is responsible for developing content and delivering on the milestones of assigned projects. The Sr. Publication Specialist serves as a subject matter expert in the development of manuscripts, abstracts, and podium presentations and other scientific materials which communicate clinical evidence to the physician community across CRM therapies. This may include performing literature searches and reviews as needed to support evidence strategies and planning. The publication professional may own the publication plan, coordinate publication committee activities, drive content decisions on manuscripts, provide medical writing and editing support while observing corporate, regulatory and medical society standards.
Responsibilities may include the following and other duties may be assigned. Writes and edits manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for incompany use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. Compiles, analyzes, and summarizes additional data from other sources as needed. Prepares literature for new products, and revises existing literature. Writes and maintains files on informative journal abstracts according to current or estimated future needs. Composes medical papers from outlines provided by doctors for presentations. May prepare responses regarding company products, drugs, or diseases and refers indepth technical inquiries to medical personnel. Requires knowledge of product areas, current developments, and keeping abreast of current literature. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
HM's Top 3:
- Medical writing within a clinical research context (e.g. scientific, peer reviewed manuscripts reporting on primary or secondary outcomes)
- Experience in medical device or pharmaceutical company
- Experience with cardiac rhythm concepts or general cardiology experience
Years’ Experience Required: 4 years medical writing or related field (or 2 years with advanced degree)
40 hours per week
Onsite Preferred
The publications team, a part of the CRM Clinical Research and Medical Affairs Team, is responsible for managing the publications process and supports global evidence dissemination from Medtronic-sponsored clinical trials, registries, and other research data. Publication professionals in this role work closely with Principal Investigators and internal team members from the clinical study team, statistics, clinical leadership and cross-functional SMEs.
The Senior Publications Specialist is responsible for developing content and delivering on the milestones of assigned projects. The Sr. Publication Specialist serves as a subject matter expert in the development of manuscripts, abstracts, and podium presentations and other scientific materials which communicate clinical evidence to the physician community across CRM therapies. This may include performing literature searches and reviews as needed to support evidence strategies and planning. The publication professional may own the publication plan, coordinate publication committee activities, drive content decisions on manuscripts, provide medical writing and editing support while observing corporate, regulatory and medical society standards.
Responsibilities may include the following and other duties may be assigned. Writes and edits manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for incompany use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. Compiles, analyzes, and summarizes additional data from other sources as needed. Prepares literature for new products, and revises existing literature. Writes and maintains files on informative journal abstracts according to current or estimated future needs. Composes medical papers from outlines provided by doctors for presentations. May prepare responses regarding company products, drugs, or diseases and refers indepth technical inquiries to medical personnel. Requires knowledge of product areas, current developments, and keeping abreast of current literature. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
