Medical Writer II, Oncology

Purpose

• Develops within the medical writing role within the pharmaceutical industry. Works in a team environment and matrix. Performs routine tasks per established procedures. Gains knowledge and applies internal standards, regulatory, and publishing guidelines. With increasing skill, uses internal systems, tools, and processes. Writes and coordinates basic documents, preparing more complex documents (within the TA and across TAs) in accordance with experience level. Functions as a lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision. Participates in process working groups.
• You will be responsible for: Writes and coordinates basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs. Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision. Performs document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed. Participates in and may lead cross-functional document planning and review meetings. Works in a team environment with some guidance while increasing independence for longer-term activities. Takes an active role on assigned projects with respect to timing, scheduling, and tracking. Interacts with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• In accordance with experience level: guides or trains cross-functional team members on processes and best practices. leads early- or late-stage compound writing teams with supervision, as required. Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide. Regularly meets with manager and mentors and attends departmental meetings. Attends cross-functional meetings as appropriate (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings). Completes all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems. Maintains and applies knowledge of industry, company, and regulatory guidelines. Mentors more junior staff on document planning, processes, content, or provide peer review.
• Qualifications /
• Requirements: A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. A minimum of 2 years of relevant pharmaceutical/scientific experience is required. A minimum of 2 to 4+ years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed. Strong oral and written communication skills. Attention to detail. Ability to function in a team environment. Organizes time well. Demonstrates learning agility. Builds solid and productive relationships with cross-functional team members. Gains experience in interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content with supervision. Emerging leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves basic problems independently and more complex problems with supervision. Develops and applies knowledge of regulatory guidance documents such as ICH requirements.
• Required
• Skills:
• Preferred
• Skills: Business Behavior, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Copy Editing, Data Gathering and Analysis, Data Savvy, Document Management, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards,
• Research
• Ethics
• The anticipated base pay range for this position is : $74,000.00 - $119,600.00
• Additional
• Description for
• Pay
• Transparency: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information

Healthcare Worker I (Casual)