Auftragsdetails

Detailed Description

• In collaboration with medical writing leadership, defines and manages medical writing and quality control (QC) resource needs, and communicates with recruiting and business development in a timely and effective manner.
• Ensures appropriate communication on project and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants.
• Manages clinical program documents for assigned clients, such as protocols, investigator’s brochures, informed consent forms, patient narratives, clinical study reports, and more complex regulatory documents (eg, IND, NDA, BLA, MAA, eCTD submission-level documents).
• Provides medical writing project management oversight of client(s) to develop and maintain existing and new client relationships and manage medical writing deliverables and resourcing needs.
• Leads cross-functional coordination of resources (eg, internal resources/consultants) to manage medical writing and QC deliverables.
• With minimal supervision, authors (writing/editing) high-quality clinical and regulatory documents in all phases of clinical research and in various therapeutic areas including, but not limited to, the following: clinical study protocols, protocol amendments, clinical study reports, patient narratives, investigator brochures, informed consent forms, lay summaries, and more complex regulatory documents (eg, IND, NDA, BLA, MAA, eCTD submission-level documents).
• Supervises and mentors less experienced medical writers, as necessary.
• Adheres to established regulatory standards including, but not limited to, the following: International Conference on Harmonisation (ICH) E3 and ICH E6(R2) guidelines, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
• Strives to complete medical writing deliverables on time and within budget.
• With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings such as project kickoff and comment review, and manages the deliverable timelines.
• Interacts and collaborates, as needed, with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., to produce writing deliverables.
• Coordinates QC reviews of documents and maintains audit trails of changes.
• Reviews statistical analysis plans and table/figure/listing shells for appropriate content, grammar, format, and consistency.
• If requested by supervisor, performs QC review (eg, reviews in-text tables against statistical output).
• Performs peer review of documents written by other medical writers, as required.
• Assists with project-related administrative tasks (eg, creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
• Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
• Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
• Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
• Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team.
• Participates in and leads departmental initiatives (eg, process improvement, lunch and learns etc.)

• Advanced knowledge of clinical research principles and solid ability to interpret and present clinical data and other complex information.
• Advanced understanding of FDA/EMA and applicable ICH regulations and guidelines.
• Advanced understanding of regulatory submission requirements and processes.
• Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.
• Exceptional project management skills and strong communication skills with a high attention to detail and quality.
• English language proficiency and familiarity with American Medical Association (AMA) style.
• Strong experience in relationship building and strategic collaboration on key business accounts.
• Thinks proactively, takes initiative, and willingly takes on new challenges.
• Ability to identify areas of concern or inefficiency and propose solutions for consideration by management team to improve overall efficiency and quality of deliverables.
• Works independently with exceptional time management skills and contacts management team proactively when additional support and resources are needed.
• Works effectively in a collaborative team environment.
• Demonstrates a growth mindset and positive outlook in all work activities.

• Minimum of Bachelor of Science degree (life sciences preferred); advanced degree (eg, Master of Science or PhD) preferred.

• Minimum of 8 years of experience in writing clinical or regulatory documents for drugs, biologics, and/or medical devices for a contract research organization, pharmaceutical company, or biotechnology company. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.