Medical Writing Editor
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
The key tasks of the Medical Writing Editor will be:
Providing technical writing & editing support.
Reviewing regulatory and clinical research technical documents, including protocols, clinical study reports, informed consent forms, investigator brochures, and other regulatory documents.
Copy editor duties focused on proofreading documents for text, content, and syntax consistency so as to help facilitate the successful production and completion of such deliverables in a professional and polished manner.
You'll be accountable for:-
Ensures timelines are met promptly.
Is responsible for providing editing, formatting, and general assistance to members of the medical writing team.
Drives the compilation of documents into a final product.
Takes the initiative to be proactive and search out tasks before they are given.
For project success:
Liaises with various departments, including medical writing, regulatory, pharmacokinetics, etc.
Works within these various departments to facilitate timelines are met and document quality control reviews are completed.
Provides general editing assistance (eg, grammar, punctuation, spelling, formatting) and quality control checks for clinical study reports (shell and draft), appendices, and tables and figures (Section 14).
Creates in-text tables for clinical study reports and inserts hyperlinks/bookmarks as needed.
Prepares clinical study reports and related regulatory documents for finalization in accordance with eCTD guidance and FDA PDF specifications.
Audits study files for SOP compliance.
For commercial success:
Ensures client specifications are completed successfully and medical writing documents are stored or archived appropriately.
Assists medical writing with any other client related services as necessary.
Mentors colleagues for compliance with FDA and Premier guidances.
Interacts with internal specialists and Premier's consultants when appropriate.
Helps develop and expand the scope of this position within medical writing and regulatory affairs as aligned with the goals of the employer and employee.
Participates in corporate initiatives and actions that ensure the continued success of the company.
Provides a variety of technical skills, especially in programs such as Microsoft Office and Adobe Acrobat.
Maintains and develops document templates.
Maintains working knowledge of departmental standard operating procedures and FDA/ICH guidelines.
Reviews and updates the standard operating procedures, associated documents, and working guidelines as required.
Exhibits professional conduct at all times.
Maintains familiarity with literature search techniques.
Participates in staff, departmental, and company meetings.
Adheres to required Premier Research training plan.
Other activities as designated.
EDUCATION, SKILLS & COMPETENCIES:
Undergraduate degree (BA/BS) or its international equivalent from an accredited institution
Scientific/technical background preferred
Previous related experience (clinical trials, publishing, writing or editing)
Expert in Microsoft Office and Adobe Acrobat
Must be able to communicate effectively with co-workers, handle remote or virtual work/office environment and global time differences
Requires excellent typing skills, ability to use and modify templates, and ability to create and manage large electronic files and documents
Requires analytical skills and a working knowledge of medical terminology
Effectively plans, schedules and coordinates writing assignments
Prior experience using technical software preferred
Prior experience with training and mentoring staff preferred
Clinical trials support or pharmaceutical industry experience preferred
Knowledge of ICH and local regulatory authority drug research and development regulations preferred
Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development.
Knowledge of web based communication tools and various technical programs, including but not limited to Adobe Adobe, Microsoft Office, etc.
Knowledge of AMA style guidelines.
Fluent verbal and written English
Collaborative, and able to build an effective team.
Ability to multitask and work effectively in a fast-paced environment with changing priorities
Strong verbal and written communication and negotiation skills
Excellent organizational and time-management skills; able to prioritize work to meet deadlines
Accountable, dependable, and strong commitment
Maintains a positive, results-orientated work environment