Thermo Fisher Scientific Job opening for Medical Writer, Clinical Compliance Specialist III

Location: Work From Home

Responsibilities As Clinical Compliance Specialist

• Leading Process Improvement Initiatives: Make sure documentation complies with ALCOA standards and handle concerns using organized problem-solving techniques.
• Collaborate with representatives from other departments to manage compliance-related tasks, such as client audits and CAPA.
• Training and Mentoring: Assist junior team members in their development and make sure our quality standards are consistently met by offering them assistance.
• Analyzing Data and Making Decisions: To successfully implement high-quality strategies and make wise business decisions, interpret and evaluate data.

Responsibilities as Medical Writer

• Conducts independent research, drafts, and edits informed consent forms, study protocols, clinical study reports, and other peri- and post-approval regulatory papers. May accommodate sections of INDs, NDAs, and CTDs, as well as intricate clinical or scientific documents like IBs.
• Without supervision, plans, organizes, and executes all project-related tasks, such as creating standards, budgets, schedules, projections, and contract revisions. Communicates with various functional units (e.g., clinical, QA, data management, project management, biostatistics, regulatory, and other Evidera practice areas) as needed. promptly detects, escalates, and suggests solutions for project activities that are outside of its purview.
• works on a variety of issues where evaluating identifiable components is necessary for data analysis.
• Deals with important issues that frequently call for cooperation between functional areas in interactions with both internal and external individuals. networks include senior internal
• usually only gets broad instructions on new assignments and less guidance on daily tasks. Shows sound judgment while choosing approaches and strategies to solve problems.
• Serves as the department’s main point of contact for a variety of tasks, such as bid defenses, client audits, project launch meetings, and capability presentations. builds and nurtures relationships with clients; takes the initiative and leads conversations with clients on their own. helps with budget and proposal formulation as well as business development.

Skills And Qualification Needed To Become Medical Writer or Clinical Compliance Specialist

For Medical Writer

• A scientific bachelor’s degree, or its equivalent, together with a pertinent formal education or work experience is required; an advanced degree is desirable.
• Prior writing experience that gives you the know-how, aptitude, and talents to do the work (between two and five years’ worth), or an equivalent mix of education, training, and experience.
• Preferred is prior experience working in the CRO/pharmaceutical industries.
• It is beneficial to get further medical writing certifications (AMWA, EMWA, BELS, RAC).
• substantial familiarity with national, international, regional, and other document development norms.
• comprehensive understanding of a certain field, such as medicine, regulatory filings, medical messaging, etc.
• Outstanding computer abilities, including mastery of client templates; solid familiarity with document management systems and other pertinent programs (e.g. Excel, Outlook).

For Clinical Compliance Specialist

• five years of minimum applicable experience along with a bachelor’s degree or its equivalent.
• Extensive knowledge of the clinical trial procedure and awareness of ICH GCP, as well as other applicable rules and recommendations.
• strong ability to solve problems, including corrective and preventive measures as well as root cause analysis.
• Excellent time-management and organizing abilities.
• good digital literacy and attention to detail.
• Capacity to efficiently manage workload and prioritize conflicting requests.
• Adaptability, flexibility, and the capacity to foster collaboration in a multidisciplinary environment.
• Excellent critical thinking abilities and the capacity to organize tasks to produce outstanding outcomes.

How To Apply

• Go to the Thermo Fisher Scientific Careers area by using the menu or the link that is often located at the bottom of the webpage.
• Enter the job ID (R-01256838) or the title (Clinical Compliance Specialist III) in the search bar. or For Medical Writer U can Search This ID – R-01250321
• Then Click On Apply Button and Fill The Application Form
• Timely Check Your Mails To Get Interview Calls

Application Link For Medical Writer

Application Link For Clinical Compliance Specialist

https://chat.whatsapp.com/DO9PMPj2H3K4SikyHri52x

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