Senior Medical Editor

hace 4 semanas

Bilbao, Vizcaya, España Pharmiweb A tiempo completo
Job Title: Senior Medical Editor - Regulatory Compliance Specialist

Job Summary: We are seeking a highly skilled Senior Medical Editor to join our team at Pharmiweb. As a Senior Medical Editor, you will be responsible for maintaining familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.

Key Responsibilities:

Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.

Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.

Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.

Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles.

Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable.

Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process.

Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices.

Performs data integrity review of assigned documents to ensure accuracy.

Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.

Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.

Requirements:

Bachelor's degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.

Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred.

Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills.

Excellent grammatical and communication skills, both written and oral.

Extensive familiarity with the AMA style guide strongly preferred.

Ability to work with minimal supervision on multiple assignments with set deadlines.

Ability to work independently as well as part of a team and keep others informed of the progress and status of projects.

Adaptable to changes in work duties, responsibilities, and requirements.

Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.

About Us:

Pharmiweb is a leading biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Why Work with Us:

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

What We Offer:

Competitive salary and benefits package

Opportunities for career growth and professional development

Collaborative and dynamic work environment

Recognition and rewards for outstanding performance

Comprehensive training and development programs

Flexible work arrangements and work-life balance

Access to cutting-edge technology and resources

Collaborative and supportive team environment

Opportunities for professional growth and development

Recognition and rewards for outstanding performance

Comprehensive training and development programs

Flexible work arrangements and work-life balance

Access to cutting-edge technology and resources

How to Apply:

If you are a motivated and experienced Senior Medical Editor looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you

Equal Employment Opportunity:

Pharmiweb is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and diverse work environment that reflects the communities we serve.

Accommodation:

Pharmiweb is committed to providing a barrier-free work environment and welcomes applications from people with disabilities. If you require an accommodation during the recruitment process, please let us know and we will work with you to meet your needs.

Confidentiality:

All applications will be kept confidential.

Disclaimer:

Pharmiweb reserves the right to modify or withdraw this job posting at any time without prior notice.

Language:

en

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