9 Medical Writer II Jobs in Plymouth, MN
LanceSoft Inc is Hiring a Medical Writer II Near Plymouth, MN
- Writes and contributes to Clinical Evaluation reporting deliverables including Post-Market Surveillance Plans and Periodic Safety Update Reports (PSURs), Regulatory Responses and other related documentation.
- Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for regulatory submissions and the maintenance of clinical evaluation report files.
- Collaborates with team members and stakeholders in planning for and supporting PSUR related projects and processes.
- Supports additional clinical, regulatory, quality and engineering related deliverables as assigned.
- Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Quality Engineering, and Medical Affairs in completing clinical evaluation project related deliverables.
- Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
- Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Reports and Plans (CER/CEP), clinician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
- Authors and contributes to necessary documents to regulatory submissions and communications, such as regulatory inquiries.
- Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable *** SOPs.
- Excellent written and verbal communication skills
- Experience with collaborative, cross-functional teams.
- Excellent analytical skills and ability to manage complex tasks and manage time effectively
- Proficient with Word, Excel, PowerPoint, Outlook, etc.
- High level of attention to detail
- Ability to prioritize key business objectives and respond quickly to changing priorities
- Ability to work independently with minimal daily instruction
- Able to multitask and work in a fast-paced environment
- Bachelor’s Degree required in related field
- Minimum of 2 years medical writing experience in the medical or pharmaceutical industry or 5 years general technical writing experience required
- Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills
- PSUR writing experience strongly preferred
- Literature search experience is preferred
- Biomedical, sciences, medicine or similar health related discipline preferred
- Typically requires travel less than 5% of the time
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
Job Summary
Full Time
Business Services
$75k-93k (estimate)
06/21/2024
07/19/2024
lancesoft.com
HERNDON, VA
500 - 1,000
2000
Private
DIVYA GANDHI
$200M - $500M
Business Services
Related Companies
About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
The job skills required for Medical Writer II include Medical Writing, Clinical Research, Attention to Detail, PowerPoint, Regulatory Affairs, Pharmaceutical Industry, etc. Having related job skills and expertise will give you an advantage when applying to be a Medical Writer II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Medical Writer II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Medical Writer II positions, which can be used as a reference in future career path planning. As a Medical Writer II, it can be promoted into senior positions as a Medical Writer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Medical Writer II. You can explore the career advancement for a Medical Writer II below and select your interested title to get hiring information.
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