Medical Writer Saint Paul,MN Contract
Medical Writer must be proficient in writing and editing technical scientific documents and managing content at all stages of development.
Must have a thorough knowledge of clinical research concepts, practices, medical devices, FDA regulations, ICH Guidelines regarding drug development phases, clinical research and medical writing standards.
Understand client’s business needs and objectives and be able to learn the assigned science and therapeutic disease states.
Must work with a cross-functional and global team and must collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokinetics to interpret study results and ensure the statistical interpretations are accurately and clearly reflected in relevant documents.
Must create and maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables.
Must function as the content team expert and collaborate with cross-functional teams, internally and externally, and ensure consistency and quality across all documents; provide high quality deliverables within the specified timeline.
Familiarity with PTC's Windchill – PLM(CMS) tool implementation process.
Medical Writing / Scientific Writing / Content Writer / Technical Writing / Medical Writer / Medical Documentation / Clinical Research/FDA/Diagnostic Devices/Medical Devices
UG: B.Sc Life Science or Bio technology, B.E Medical Electronics, Any Graduate - Any Specialization.
PG: Medical sciences, Bio Technology or life Science
Desired Candidate Profile
10 years of technical writing experience in Medical Domain.
Educational Background: Bachelor’s Degree/Master’s Degree equivalent in medical-related field or life science.
The Medical Writer is proficient in writing and editing technical scientific documents and managing content at all stages of development.
Able to convey and assimilate strategic, complex and/or detailed information.
Experience in interacting with cross functional team members and must have working experience as an onsite coordinator.
Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
Knowledge on DDLC and SOP would be an added advantage.
Required proficiency in Adobe tools.
Strong written and verbal communication skills.