Medical Writer

Medical Writer #18400

12 month W2 contract, extendable and potential to convert

100% remote – preferably EST, CST, or PST

Top 3 things the manager is looking for: 

1. Solid understanding of clinical evaluation and EU MDR. Independently project manage 
2. Previous PSUR writing experience or experience writing documents relevant to EU MDR
3. Works independently with general supervision on larger, moderately complex projects / assignments
4. Top 3 Tasks or Responsibilities in scope for this role: Ability to draft and author PSUR from start to finish
5. Well versed in using Microsoft word and Template use (Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities. Compiles, analyzes, and summarizes additional data from other sources as needed)
6. Communicates primarily and frequently with internal contacts. Big picture thinking with problem solving skills

University degree with minimum two years’ experience. Masters level preferred

Hours: 40 

Location: Remote – time zone: preferably CST, Eastern or PST

Medical Writer for EU MDR. Writes and edits documents for EU MDR clinical and post-market surveillance documents (CEP, SSCP, PSUR),or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. 

• Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities. Compiles, analyzes, and summarizes additional data from other sources as needed. Solid understanding of MEDDEV and EU MDR.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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 1 years of experience.