Johnson & Johnson Innovative Medicine is hiring: Analyst II, Medical Writing, Im

Analyst II, Medical Writing, Immunology

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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.

Purpose

• Develop and write medical documents within the pharmaceutical industry.
• Work in a team environment and matrix.
• Perform routine tasks per established procedures.
• Apply internal standards, regulatory and publishing guidelines.
• Use internal systems, tools, and processes as skill increases.
• Write and coordinate basic documents; prepare more complex documents (within the TA and across TAs) in accordance with experience level.
• Function as a lead writer on a project, indication, or a compound at early- or late‑stage under close supervision.
• Participate in process working groups.

You Will Be Responsible For

• Write and coordinate basic clinical documents such as Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs.
• Write, contribute to, and/or coordinate low‑ to medium‑complexity clinical and regulatory documents such as Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Perform document QC, complete abbreviation lists or references, conduct literature searches, and perform other basic tasks with supervision as needed.
• Participate in and may lead cross‑functional document planning and review meetings. Work 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.
• Interact with cross‑functional colleagues on document content and champion 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.
• In accordance with experience level:
  • Guide or train cross‑functional team members on processes and best practices.
  • Lead early‑ or late‑stage compound writing teams with supervision, as required.
• Learn and adhere to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Regularly meet with manager and mentors and attend departmental meetings.
• Attend cross‑functional meetings as appropriate (eg, project kick‑off and review meetings, study team meetings, Global Program Team meetings).
• Complete all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintain and apply knowledge of industry, company, and regulatory guidelines.

Qualifications / Requirements

• Education: A university/college degree in a scientific discipline is required. An advanced degree (Masters, PhD, MD) is preferred.

Skills / Experience

• Minimum of 2 years of relevant pharmaceutical/scientific experience.
• 0 to 4 years of regulatory medical writing experience, 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.
• Effective time‑management.
• Demonstrates learning agility.
• Builds solid and productive relationships with cross‑functional team members.
• Experience in interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content with supervision.
• Emerging leadership skills in project and process management, time management, influencing, negotiating, assertion, and initiative.
• Develops and applies knowledge of regulatory guidance documents such as ICH requirements.

Compensation

Expected pay range: $89,000 to $143,750.

Benefits

Employees may be eligible to participate in the Company’s consolidated retirement plan (401(k)) and savings plan, medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Time‑off benefits include vacation, sick time, holiday pay, and floating holidays.

Equal Employment Opportunity

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Accommodations

If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.