Medical Writer

Job Overview

The Medical Writer is responsible for the generation and development of documents related to clinical documentations and investigations as applicable.

Job Responsibilities and Essential Duties

• Serves as a clinical evaluation lead and participates within the clinical evaluation team for the development and generation of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR and MDCG guidance. Contribute to the Summary of Safety and Clinical Performance. (20%)
• Serves as point and participates in the Post-Market Clinical Follow-up (PMCF) team. Specifically contributes to the literature review and the identification and analysis of clinical data related to the PMCF evaluation. (20%)
• Perform comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required. (10%)
• Analyze available clinical evidence (data held by the manufacturer, published literature) to evaluate the safety and performance of the subject device under evaluation. (10%)
• Write and or edit clinical study documentation, including clinical investigational plans/protocols, Investigator's Brochures, Periodic reports, Clinical Investigational Reports/Clinical Study Reports. Ensure high quality study documentation that is submission-ready for various regulatory agency and external distribution. (10%)
• Contribute to clinical aspects of Technical documentation. (10%)
• Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals. Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission. (5%)
• Write and/or contribute to abstracts and submissions of clinical data to various medical congresses or symposia. Work with medical professionals to ensure high quality submissions and data integrity. (5%)
• Contribute to the development and optimization of Clinical Affairs SOPs, as needed. (5%)
• Perform other non-routine duties as assigned by the Supervisor. (5%)

Minimum Requirements

• Bachelors, Master's degree or PhD in a relevant scientific discipline, or equivalent.
• 1-5 years medical writing experience.
• Direct experience working on clinical evaluations within the Medical Device industry a plus.
• Medical writing certification a plus.

Required Knowledge, Skills and Abilities

• Strong interpersonal and communication skills.
• Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives.
• Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions.
• Outstanding oral and written communication skills.
• Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review/literature management tools a plus.
• Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, MDCG guidance documents, ISO 14155, ICH guidance including E3 CSR, E6 GCP, and familiarity regulations/ guideline relating to Risk management (i.e., ISO 13485 and ISO 14971)
• Demonstrated ability to work independently and as part of a team.
• Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.
• Advanced skills using Microsoft Office products such as Outlook, Word, Excel and Power Point.

Supervision/Management Of Others:

• N/A

Internal and External Contacts/Relationships

• Internal Getinge teams such as Medical Affairs, Regulatory Affairs, Quality Engineering,

Research & Development and Marketing, as needed.

• External teams such as CROs, clinical vendors and key opinion leaders, as needed.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices
• to complete assignments.
• Duties are performed in an office environment.
• Travel requirements will vary depending on status of the current projects.

110K to 120K annual with 10% STIP

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