Analyst II, Regulatory Medical Writing

Johnson & Johnson • Indianapolis, IN

446d

About The Position

The Analyst II, Regulatory Medical Writing position at Johnson & Johnson involves supporting the Regulatory Medical Writing team within the Immunology therapeutic area. The role requires preparing and finalizing clinical documents, ensuring quality and accuracy, and participating in cross-functional meetings. The position is open to candidates in North America, Europe, or other global locations, emphasizing the company's commitment to diversity and inclusion in the workplace.

Requirements

• University/college degree required; Masters or PhD preferred.
• At least 2 years of relevant pharmaceutical/scientific experience; previous regulatory medical writing experience is preferred.
• Ability to learn and interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in documents under supervision.
• Attention to detail.
• Strong oral and written communication skills.
• Emerging leadership skills in time management and project/process management.
• Ability to resolve basic problems independently and complex problems under supervision.
• Demonstrate learning agility.
• Ability to build solid and positive relationships with cross-functional team members.

Responsibilities

• Prepare and finalize clinical documents such as clinical study reports, investigator's brochures, protocols, summary documents, briefing books, and regulatory responses.
• Perform document quality control, generate lists of abbreviations and references, conduct literature searches, and complete other basic tasks.
• Participate in and may lead cross-functional document planning and review meetings.
• Interact with peer writers and colleagues from other departments.
• If a lead writer for a compound or document, act as the primary point of contact and champion for medical writing activities for the clinical team, establishing document timelines and strategies with mentorship as needed.
• Learn and adhere to SOPs, templates, best practices, policies, and the Medical Writing Style Guide.
• Acquire, maintain, and apply knowledge of the industry, company, and regulatory guidelines.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) retirement plan
• Vacation up to 120 hours per calendar year
• Sick time up to 40 hours per calendar year
• Holiday pay 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
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree