Senior Analyst, Oncology Regulatory Medical Writing

Senior Analyst, Oncology Regulatory Medical Writing

At Johnson & Johnson Innovative Medicine (IM), what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

IM Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.

Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team are recruiting for a Senior Analyst Regulatory Medical Writing to support our Oncology therapeutic area. The position may be located in the US, UK, other European countries, or Canada. R e mote work options may be considered on a case-by-case basis and if approved by the company.

Are you ready to join our team? Then please read further!

Key Responsibilities:

• Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.
• Lead cross-functional document planning and review meetings. Interact with peer writers and colleagues from other departments. Able to lead program-level or submission writing teams with supervision. Able to lead process working groups.
• Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.
• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• If a lead writer for a program: Be the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning, setting strategy, and leading writing group for assigned program.
• Maintain and apply knowledge of the industry, company, and regulatory guidelines.

Principal Relationships:

• Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.
• External: 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.

Note: this is not a line-management position.

Education:

University/college degree required. Masters or PhD preferred.

Experience and Skills:

• At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience.
• Oncology 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.
• 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 time and project/process management/leadership skills.
• Able to resolve complex problems under supervision.
• Demonstrate learning agility (self-development) and mentoring competency (development of others).
• Strong attention to detail.
• Travel up to 10%

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The anticipated base pay range for this position is 105000 to 169050.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits: - 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 of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.