Medical Writer III

Johnson & Johnson Innovative Medicine • Horsham, PA

14h • Hybrid

About The Position

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. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. We are searching for the best talent for a Medical Writer III within our Regulatory Medical Writing team, part of Integrated Data Analytics & Reporting (IDAR), to support our Immunology therapeutic area. This position may be located in High Wycombe, United Kingdom; Leiden, The Netherlands; Beerse, Belgium or Spring House / Raritan/Titusville, United States. This is a hybrid position (3 days per week onsite, 2 days work from home). Remote work options may be considered on a case-by-case basis and if approved by the company. The Medical Writer III will be able to write and coordinate basic and complex documents, independently when working within own therapeutic area (TA), and under supervision when working across TAs. They will lead in a team environment and matrix, and function as a lead MW on most compounds, under supervision. They will actively participate in or lead process working groups and provide input into functional tactics/strategy.

Requirements

• A university/college degree in a scientific discipline is required.
• At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience!
• Proficiency in written and spoken English is essential.
• Ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine.
• Able to build solid and positive relationships with cross-functional team members.
• Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
• Resolves complex problems under supervision.
• Demonstrate learning agility (self-development) and mentoring competency (development of others).
• Strong attention to detail.
• Required Skills: Cross-Functional Teamwork, Medical Writing, Regulatory Writing

Nice To Haves

• An advanced degree (eg, Masters, PhD, MD) is preferred.
• Immunology therapeutic area experience is strongly preferred.
• Compound lead and/or submission lead experience is preferred.
• Preferred Skills: Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Immunology, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)

Responsibilities

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional (eg, with clinical team) document planning and review meetings.
• Interacting 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.
• Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
• Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
• Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coaching or mentoring more junior staff on document planning, processes, and content.
• Provides peer review as needed.
• Actively participating in or leads process working groups.

Benefits

• annual performance bonus
• medical insurance
• dental insurance
• vision insurance
• life insurance
• short- and long-term disability insurance
• business accident insurance
• group legal insurance
• Company’s consolidated retirement plan (pension)
• savings plan (401(k))
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees