Manager, X-TA Regulatory Medical Writing Job at Johnson & Johnson Innovative Med

Overview

Manager, X-TA Regulatory Medical Writing

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 seeking a talented professional to join the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business, to support one or more therapeutic areas. The position is hybrid with potential location in the UK, Belgium, Netherlands, or the United States. Remote work options may be considered on a case-by-case basis and with approval.

Note: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Applications may be submitted to one or more postings; however, they will be considered as a single submission.

Responsibilities

• Prepare and finalize all types of clinical documents independently within and across therapeutic areas (TAs).
• Lead in a team environment with a high degree of independence, taking a lead role on content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
• Lead and actively participate in setting functional tactics/strategy as needed.
• Oversee the work of external contractors.
• Lead or set objectives for others on team projects, e.g., leading process working groups.
• Coach or train cross-functional team members on processes and best practices; provide mentoring and review as needed.
• Potentially lead project-level/submission/indication writing teams; act as primary point of contact and champion for medical writing activities for the clinical team when serving as lead writer.
• Participate in medical writing and cross-functional meetings; provide recommendations for departmental process improvements.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Interact with senior cross-functional colleagues to strengthen coordination between departments.
• Represent Medical Writing in industry standards working groups as needed.
• Complete all time reporting, training, and metrics updates in relevant company systems.

• If a people manager: Manage a team of internal medical writers (direct reports); set objectives for individuals; conduct career and talent development discussions; ensure project assignments and issues are resolved; ensure adherence to policies and templates; be accountable for the quality and compliance of deliverables; participate in resource management and hiring decisions.

Education And Experience

• University/college degree required. Masters or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
• If a people manager, preferably up to 2 years of people management experience.

Other Requirements

• Experience in multiple therapeutic areas preferred.
• Attention to detail; excellent oral and written communications; English fluency required.
• Strong project/time management and leadership skills.
• Ability to interpret, summarize, and present statistical and medical information accurately.
• Ability to resolve complex problems independently and demonstrate learning agility.
• Ability to build and maintain positive cross-functional relationships.
• Solid knowledge and application of regulatory guidance documents (e.g., ICH).

Location, Schedule & Compensation

The position is hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and with company approval. The anticipated base pay range for the United States is $115,000 to $197,000 (USD), with eligibility for an annual performance bonus. Benefits include medical, dental, vision, life insurance, disability coverages, retirement plans, and paid time off per company policy.

Equality And Inclusion

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status, and will not be discriminated against on the basis of disability.