Sr. Medical Writer – Clinical/Regulatory
Must Have: Minimum Requirements
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Bachelor’s Degree with a minimum of 4 years of medical/clinical writing experience (i.e., developing scientific/clinical publications or reports) or advanced degree with a minimum 2 years of relevant experience as listed above
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Experience in medical writing within the healthcare industry or academia or in a related area such as quality, regulatory, clinical research, or product support/R&D
- PhD or PharmD with 3+ years of relevant experience
- Prefer candidate with experience in medical device, bio-tech and pharmaceutical industry
- Demonstrated project management experience
- Knowledge of clinical research methodology, tools, processes and regulations
- Ability to critically analyze and interpret scientific data (clinical and preclinical preferred)
- Strong knowledge of regulatory guidance relative to Clinical Evaluation Reports - the essential requirements for safety and performance of Medical Devices as defined in the Medical Device Directive and the Active Implantable Medical Device (AIMD) Directive, the MEDDEV and EN ISO 14155.
- Knowledge and experience with Design History File, Technical File, Design Dossier, Clinical Study Report, Clinical Evaluation Report content templates. Working knowledge of current electronic document management systems and information technology.
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Highly proficient in the use of Microsoft Office Suite software, Adobe software, and EndNote Reference software
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Adept in performing literature searches in Pubmed and other relevant platforms
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Self-motivated team player
- Highly motivated and capable of comprehending large amounts of scientific content, which is then communicated in a clear, concise fashion.
- Expertise in literature identification and analysis
- Ability to independently coordinate and prioritize multiple projects simultaneously
- Ability to build and foster relationships with key business stakeholders and cross-functional team members
- Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.