Johnson & Johnson

Director, Medical Writing

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: TitusvilleNew JerseyPennsylvaniaUnited States

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Salary

💰 $164,000 - $282,900 per year

Job Level

About the role

  • Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals.
  • Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles.
  • Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions.
  • Provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence.
  • Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments.
  • Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently.
  • Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration.
  • Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members.
  • Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed.
  • Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems.
  • Participate in industry standards working groups to represent MW and ensure alignment with best practices.
  • Acts as the primary interface with the Compound Development Teams (CDTs) at the early stages of submission preparation and as a MW expert for the delivery of Johnson & Johnson Innovative Medicine marketing applications.

Requirements

  • A university/college degree in a scientific discipline is required.
  • An advanced degree (eg, Masters, PhD, MD) is preferred.
  • Minimum of 14 years of relevant pharmaceutical/scientific experience is required.
  • Minimum of 12 years of relevant clinical/medical writing experience is required.
  • Expertise in project management and process improvement is required.
  • Strong decision-making skills, strategic thinking, agility, broad vision is required.
  • Excellent oral and written communication skills.
  • Attention to detail.
  • Expert time management for self, direct reports (if applicable), and teams.
  • Ability to delegate responsibility to other medical writers.
  • Expert ability to lead and influence by example and stay focused (positive).
  • Demonstrate integrity.
  • Expert ability to motivate and develop best in class talent pipeline.
  • Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers.
Benefits
  • medical
  • dental
  • vision
  • life insurance
  • short and long-term disability
  • business accident insurance
  • group legal insurance
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • long-term incentive program
  • vacation – 120 hours per calendar year
  • sick time - 40 hours per calendar year
  • holiday pay, including Floating Holidays – 13 days per calendar year
  • work, personal and family time - up to 40 hours per calendar year
  • parental leave – 480 hours within one year of the birth/adoption/foster care of a child
  • bereavement leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • caregiver leave – 80 hours in a 52-week rolling period
  • volunteer leave – 32 hours per calendar year
  • military spouse time-off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical writingregulatory writingsafety documentationproject managementprocess improvementstrategic planningdocument planningscientific strategysubmission preparationpharmaceutical experience
Soft Skills
decision-makingstrategic thinkingagilitycommunicationattention to detailtime managementdelegationleadershipintegritycollaboration
Certifications
advanced degreeMastersPhDMD