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Johnson & Johnson

Makes prescription drugs and medical devices

Manager, Medical Writing - Immunology

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeMaidenhead, UKNo salary listedHybrid

About the Job

Requirements

  • A university or college degree is required; a Master's or PhD is preferred.
  • At least 8 years of relevant pharmaceutical or scientific experience and at least 6 years of relevant medical writing experience are required.
  • Attention to detail.
  • Excellent oral and written communication skills to engage in cross-functional discussions.
  • Expert project and time management skills.
  • Strong project and process leadership skills.
  • Ability to interpret, summarize, and present statistical and medical information to ensure content quality and accuracy.
  • Ability to resolve complex problems independently.
  • Ability to demonstrate learning agility.
  • Ability to build and maintain positive relationships with cross-functional team members.
  • Solid knowledge and application of regulatory guidance documents such as International Council for Harmonisation requirements.

Responsibilities

  • Prepare and finalize all types of clinical documents.
  • Lead in a team environment and work independently, taking a lead role on assigned projects for content and scientific strategy, timing, scheduling, and tracking.
  • Lead or set objectives for others on team projects and tasks, such as leading process working groups.
  • Guide or train cross-functional team members on processes and best practices.
  • May lead project-level, submission, or indication writing teams.
  • Proactively provide recommendations for departmental process improvements.
  • When serving as lead writer for a program, act as the primary point of contact and champion for medical writing activities for the clinical team, and plan and lead the writing group for the assigned program.
  • Actively participate in medical writing and cross-functional meetings.
  • Maintain knowledge of industry, company, and regulatory guidelines.
  • Coach or mentor junior staff on document planning, processes, and content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project.
  • May interact with senior cross-functional colleagues to strengthen coordination between departments.
  • May represent the Medical Writing department in industry standards working groups.
  • Manage direct reports in Medical Writing, set individual objectives, and meet regularly with direct reports to support their development and assignments and resolve issues.
  • Make hiring decisions; onboard staff; conduct career and talent development discussions; and lead goal-setting and performance discussions.

Desired Qualifications

  • At least 2 years of people management experience is preferred.
  • Preferred skills include analytics insights, business writing, clinical research and regulations, clinical trials operations, copy editing, cross-functional collaboration, developing others, inclusive leadership, industry analysis, leadership, medical affairs, medical communications, performance measurement, quality validation, standard operating procedures, tactical planning, and team management.

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size
10,001+
Company stage
IPO
Headquarters
New Brunswick, NJ
Founded
1886

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