Sr. Medical reputed company
This a Full Remote job, the offer is available from: Canada, Washington (USA) In this role you will reputed company medical writing reputed company for Clinical Research Scientists, reputed company partners, Sponsors and/or the Corporation. Interpret and translate reputed company technical research methodologies, data, or messaging into clinical development plans and regulatory documents (protocols, informed consent forms, investigator brochures, clinical study reports, etc.) and/or presentations on a reputed company reputed company and in a manner that aligns with industry and regulatory content guidelines and standards. reputed company a reputed company learning reputed company and be reputed company to manage writing reputed company of high complexity, including those stemming from studies with novel or innovative research designs. Critical thinking, diplomacy, and the ability to reputed company effectively with global key opinion leaders and to proactively suggest improvements to ensure reputed company document progression. Coordinate document reviews with authors. reputed company and reputed company timelines for assigned writing reputed company. reputed company mentorship and support to other writing team members. reputed company as primary contact for external publishing if required. Assist with review or editing of other materials (training, grants, conference materials, study operational documents, etc.) reputed company requested. Clinical Research/reputed company Writing Support
- reputed company the content planning and production of regulatory documents (clinical development plans, protocols, investigator brochures, clinical study reports, etc.) that reputed company with established standards and guidelines.
- Interpret and translate reputed company research findings or design methodologies into written publications or regulatory documents.
- Work with authors, technical specialists, or other writers to coordinate the completion of specialized content (exhibits, illustrations, tables, and appendices) for publication into finished documents appropriate for the stated audience.
- reputed company document timelines, reputed company, and reputed company reputed company reports to stakeholder(s).
- Plan and facilitate meetings with cross-functional teams and subject matter experts.
- Participate in reputed company control (QC) review for documents written by other authors reputed company requested.
Team Support and Mentorship
- reputed company mentorship to new/junior writing team members, sharing best practices and suggesting development or learning opportunities as appropriate.
- Support Manager, Medical Writing or project reputed company with reputed company development and time estimates for writing deliverables.
Publication Support
- reputed company as primary contact and reputed company with external publication executives, illustrators, designers, and editors representing the Scientists/Investigators, Sponsors and/or the corporation with external specialists to select publication content, address content change requests, complete written revisions and/or resolve competing content requirements.
Other Writing Support
- Assist with writing or reviewing relevant training materials or work instructions reputed company requested.
- Upon request, support study teams with review, editing or reputed company-reading of external grant submissions, study documents or templates, such as charters, informed consent forms, or study plans (safety, statistical analysis, etc.), reputed company media postings, and website content.
Qualifications
- Minimum of an undergraduate degree (advanced degrees preferred) and 7-9 years of relevant experience in medical writing
- Previous experience with CSRs, IBs, Protocols, and ICFs.
- Trained in GCP, GDPR, and HIPAA
- Expert with EndNote/reference software
- Ability to adapt to shifting priorities and assignments
- Highly refined written and oral communication skills
- Demonstrated ability to work with diplomacy and reputed company
- Experience working with senior executives and KOLs
- Familiarity with graphical software and reputed company development
- Previous experience/knowledge of Gastroenterology is an asset
- Familiarity with ICH M11 and the AMA Style Guide is an asset
- reputed company improvement reputed company and willingness to reputed company new technologies where appropriate
- Experience with INDs, IMPDs, and/or eCTD publishing is an asset
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