Full-Time

Senior Manager/Associate Director

Regulatory Medical Writing X-TA

Posted on 8/15/2025

Deadline 10/5/25
Johnson & Johnson

Johnson & Johnson

10,001+ employees

Global healthcare company offering pharma, devices.

Compensation Overview

$137k - $235.8k/yr

+ Annual Performance Bonus

High Wycombe, UK

Hybrid

Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.

Category
Content & Writing (1)
Requirements
  • University/college degree in a scientific discipline is required. Masters or PhD preferred.
  • At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
  • At least 2 years of people management experience.
  • Multiple therapeutic area experience preferred.
  • Strong attention to detail.
  • Strong oral and written communication skills. Fluent written and spoken English.
  • Expert project management skills, expert project/process improvement leadership.
  • Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
  • Ability to delegate responsibility to junior writers.
  • Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
  • 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 independently.
Responsibilities
  • Leading compound/submission/indication/disease area writing teams independently.
  • May have additional major responsibility with supervision.
  • Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
  • Larger organizational responsibility (eg, manage a subset of TA).
  • Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
  • Leading program-level/submission writing teams independently.
  • Directly leading or setting objectives for others on team projects and tasks.
  • Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
  • Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
  • Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.
  • Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
  • If a lead writer for a program: Primary point of contact and champion for Medical Writing activities for the clinical team.
  • Responsible for planning and leading the writing group for assigned program.
  • Able to function as a lead writer on any compound independently.
  • Leading discussions in Medical Writing and cross‐functional meetings as appropriate.
  • Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
  • Able to oversee the work of external contractors.
  • As a people manager: Manage direct reports in Medical Writing.
  • Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
  • Ensures direct report’s adherence to established policies, procedural documents, and templates.
  • Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
Desired Qualifications
  • Multiple therapeutic area experience preferred.

Johnson & Johnson operates in three main areas—pharmaceuticals, medical devices, and consumer health products—serving consumers, healthcare professionals, and institutions worldwide. It develops prescription medicines, sells surgical and vision care devices, and offers over-the-counter and personal care products, funded by direct sales, partnerships, and distribution agreements, with heavy investment in research and development. The company differentiates itself by combining three complementary businesses under one umbrella and maintaining a global footprint with an emphasis on science, innovation, and inclusive culture. Its goal is to help people live healthier lives by delivering reliable, high-quality healthcare products and solutions that improve patient outcomes.

Company Size

10,001+

Company Stage

IPO

Headquarters

New Brunswick, New Jersey

Founded

1886

Simplify Jobs

Simplify's Take

What believers are saying

  • Icotyde launches with 1,500 prescriptions, Guggenheim projects $14.9 billion peak sales.
  • Atraverse Medical acquisition bolsters HOTWIRE system for atrial fibrillation ablations.
  • ETHICON 4000 Stapler gains CE Mark, reducing surgical leaks costing €5,200 per case.

What critics are saying

  • Stelara sales plummet 60% to $656 million from Amgen and Samsung biosimilars.
  • Over 90,000 talc lawsuits trigger $966 million October 2025 verdict against J&J.
  • CARVYKTI manufacturing shortfalls cap multiple myeloma sales growth in 2026.

What makes Johnson & Johnson unique

  • Diversified revenue spans Innovative Medicine, MedTech, and consumer health segments.
  • DARZALEX sales hit $4 billion in Q1 2026, exceeding forecasts by $600 million.
  • CARTO System marks 30 years, powering AI-driven CARTOSOUND SONATA for electrophysiology.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Sick Leave

Paid Holidays

Remote Work Options

Performance Bonus

Company News

Yahoo Finance
Apr 14th, 2026
J&J's Spravato hits $468M in Q1 sales, signalling upside for psychedelics peers like Atai

Johnson & Johnson's Spravato reported $468 million in first-quarter 2026 sales, up 46% year over year, signalling potential for psychedelics-focused companies like AtaiBeckley Inc., according to Jefferies analysts. The esketamine nasal spray, approved for treatment-resistant depression, is on track to reach an annualised run rate exceeding $1.9 billion. Jefferies maintained that Spravato could hit $3 billion in annual sales by 2027 and $5 billion at peak. Over 200,000 patients have been treated globally, up from 140,000 at the start of 2025. Analysts said Spravato's commercial success demonstrates psychedelics can succeed in mainstream healthcare, with existing treatment infrastructure potentially easing adoption of emerging therapies. They highlighted ATAI's intranasal candidate BPL-003 as fitting seamlessly into Spravato's treatment paradigm.

Yahoo Finance
Apr 14th, 2026
J&J hits $100B milestone with 6.4% growth, eyes double-digit revenue by decade's end

Johnson & Johnson reported 6.4% operational sales growth in Q1 2026, raising full-year guidance to $100.2 billion — the first time the company has reached the $100 billion milestone. The company reaffirmed expectations for double-digit revenue growth by decade's end. Innovative Medicine grew 7.4%, driven by 10 double-digit growing brands including DARZALEX and TREMFYA, despite a 61.7% decline in STELARA due to biosimilar competition. MedTech posted 4.6% growth, led by heart recovery and electrophysiology divisions. The company successfully launched ICOTYDE, the first oral IL-23 peptide for immunology. Management is progressing a $55 billion US manufacturing and R&D investment through 2029, with $12 billion already deployed. The planned separation of its DePuy Synthes Orthopaedics business targets mid-2027 completion.

Business Wire
Apr 7th, 2026
Johnson & Johnson launches VARIPULSE Pro in Europe with 5x faster ablation for atrial fibrillation treatment

Johnson & Johnson has launched VARIPULSE Pro in Europe following CE Mark approval, advancing its pulsed field ablation portfolio for treating atrial fibrillation. The system features a new pulse sequence that operates five times faster than its predecessor whilst maintaining equivalent lesion quality. VARIPULSE Pro integrates with the CARTO 3 mapping system and offers a lower temperature profile whilst preserving the platform's established safety and effectiveness profiles. The company is conducting the VARIPURE multicentre study to generate clinical evidence during the commercial launch phase. The technology addresses atrial fibrillation, the most common cardiac arrhythmia affecting over 50 million people worldwide. Johnson & Johnson will showcase VARIPULSE Pro at the European Heart Rhythm Association annual meeting, with 12-month interim study results to be presented. The device is not currently approved in the United States.

Yahoo Finance
Apr 3rd, 2026
J&J's dividend stays resilient despite market sell-offs and healthcare challenges

Johnson & Johnson has raised $120 million in a Series C round led by Ribbit Capital, valuing the company at $1.45 billion. Sequoia and Kleiner Perkins participated, with Emerson Collective joining as a new backer. The pre-revenue company is developing "Mathematical Superintelligence", an AI system focused on advanced reasoning that claims to eliminate hallucinations by requiring outputs in Lean4 programming language. Its flagship model, Aristotle, achieved top-level performance at the International Mathematical Olympiad in July. Founded in 2023, Harmonic has raised $295 million across three funding rounds in 14 months. The company currently offers Aristotle via a free API and plans to commercialise in safety-critical industries like aerospace and finance.

Yahoo Finance
Apr 1st, 2026
J&J takes over NBTXR3 Phase III as Nanobiotix shifts to Curadigm, secures runway into early 2028

Nanobiotix has transferred full operational and financial responsibility for its NBTXR3 radioenhancer programme to Johnson & Johnson, with Phase III head-and-neck results expected in H1 2027 and Phase II lung cancer data anticipated in early 2027. The company is pivoting towards its Curadigm nanoprimer platform, filing four patents, starting GMP manufacturing and signing over 20 material transfer agreements with partners. Additional Curadigm data is expected before summer's end. An amended Janssen licence removing most Phase III funding obligations, combined with a royalty financing of up to $71 million, extends Nanobiotix's cash runway into early 2028. The company reported EUR 32.6 million revenue in 2025, reduced R&D spending to EUR 23.1 million, and EUR 52.8 million cash at year-end.

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