Senior Medical Editor
3 tygodni temu
As a Senior Medical Editor at Pharmiweb, you will play a crucial role in ensuring the accuracy and compliance of medical documents with FDA, EU, and other regulatory guidelines. Your expertise in medical writing, editing, and regulatory affairs will be instrumental in maintaining the highest standards of quality and integrity in our documents.
Key Responsibilities
Maintain familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
Represent the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
Monitor timelines and budgets for assigned projects and update the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
Provide technical support and expertise as appropriate. Conduct training of medical editing staff and functions as a mentor. Advise medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provide 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 that translates unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. We are committed to simplifying and streamlining our work to make us easier to work with and for. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
At Pharmiweb, 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.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Pharmiweb.
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