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

Analyst II, Medical Writing, Immunology

Johnson & Johnson Innovative Medicine – Analyst II, Medical Writing, Immunology role

Overview

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.

Job Information

Job Function: Medical Affairs Group

Job Sub Function: Medical Writing

Job Category: Professional

Locations: High Wycombe, Buckinghamshire, United Kingdom; Leiden, South Holland, Netherlands; Raritan, New Jersey, United States; Spring House, Pennsylvania, United States; Titusville, New Jersey, United States; Turnhout, Antwerp, Belgium

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.

Responsibilities

• 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.
• 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 (e.g., 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.

Qualifications / Requirements

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

Skills / Experience

• A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
• A range of 0 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.

Compensation

The expected pay range for this position is $89,000 to $143,750. The position is eligible for an annual performance bonus in accordance with applicable plan guidelines.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• 401(k) retirement and savings plan.
• Vacation – up to 120 hours per calendar year.
• Sick time – up to 40 hours per calendar year (up to 56 hours for Washington residents).
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal and Family Time – up to 40 hours per calendar year.

Equal Opportunity Employer

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.

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.