Medical Writer III

Johnson & Johnson • Titusville, PA

1d • 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. 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.

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, along with the 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.
• Able to resolve complex problems under supervision.
• Demonstrate learning agility (self-development) and mentoring competency (development of others).
• Strong attention to detail.
• Builds solid and productive relationships with cross-functional team members.

Nice To Haves

• An advanced degree (eg, Masters, PhD, MD) is preferred.
• Immunology therapeutic area experience is strongly preferred.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.
• Compound lead and/or submission lead experience is preferred.

Responsibilities

• Able to write and coordinate basic and complex documents, independently when working within own therapeutic area (TA), and under supervision when working across TAs.
• Leads in a team environment and matrix.
• Able to function as a lead MW on most compounds, under supervision.
• Actively participates in or leads process working groups.
• Provides input into functional tactics/strategy (eg, writing teams, process working groups).
• Highly proficient in the use of internal systems, tools, and processes.
• 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.
• May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision.
• May collaborate with external partner company staff on codeveloped compounds.

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• consolidated retirement plan (pension) and 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: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees