Medical Writer Senior Regulatory Writing Specialist

Medical Writer - Senior Regulatory Writing Specialist (Clinical)

Essentials:

Degree: Advanced degree in a scientific discipline (eg life sciences
pharmacy medicine) or relevant work experience;
or equivalent combination of education
training and experience.

Experience: At least 3 to 5 years as a Regulatory Medical Writer
Fluent: C1 or C2 - Fluent English
Location: Remote Brazil

POSITION SUMMARY

The Senior Regulatory Writing Specialist is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual will work directly with client teams to manage regulatory writing projects.

ESSENTIAL FUNCTIONS

To accomplish this job successfully an individual must be able to perform with or without reasonable accommodation each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.

Essential Functions Statements

• Regulatory writing skills with mastery of 3 or more regulatory document types (eg clinical study protocols clinical study reports briefing documents IND NDA and MAA components).
• Solid understanding of and ability to apply the statistical regulatory and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area. Manages at least 3 single-document projects simultaneously.
• Working knowledge of: Relevant regulatory guidance (eg ICH FDA EMA) for clinical trial conduct including document-specific guidance Core cross-functional clinical research roles and procedures and how they relate to document preparation. Acts as a primary writer and/or project manager for key documents and projects.
• Ensures document accuracy completeness and consistency of messaging. Organizes and leads cross-functional document review meetings clarifies and incorporates feedback works with cross-functional subject matter experts to resolve unclear comments and differences of opinion between functional areas.
• Performs document-level QC (including abbreviations references to sources data in text versus data in tables figures or graphs etc.) and writer peer review (logical flow sense check etc.).
• Leads project-level management activities ie timeline preparation and oversight and meeting scheduling. Participates in guiding less experienced writers on those documents for which they have expertise.
• Proactively contributes to improvements to medical writing processes.
• Understands complies with and contributes to the updates of SOPs templates best practices policies and regulatory writing style guides.
• Develops project-level lexicons and conventions.

POSITION QUALIFICATIONS

Above average attention to detail teamwork and initiative. Ability to interact with other departments within the company and be proficient in written and verbal communication.

Proficient in Microsoft Word Excel Power Point and Outlook and quickly able to learn new software. Ability to apply regulatory guidelines to content development.

SKILLS AND ABILITIES

Education: Advanced degree in a scientific discipline (eg life sciences pharmacy medicine) or relevant work experience; or equivalent combination of education training and experience.

Experience: More than 2 years (typically 3-5 years) of experience in scientific/ medical/regulatory writing in the pharmaceutical domain.

Computer Skills: Proficiency with Microsoft Word Excel PowerPoint and Outlook.

WORK ENVIRONMENT

Remote - Europe

Disclaimer

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employees ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions responsibilities skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment and the company reserves the right to change this job description and/or assign tasks for the employee to perform as the company may deem appropriate.

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex national origin age disability genetic information or veteran status.

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Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs as our in-house team manages all hiring processes.

Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.

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