Director (Ophthalmology), Clinical and Regulatory Strategic Communications (CRSC)
Merck
4 days ago
On-site
Rahway, NJ
Corporate Functions
Director (Ophthalmology), CRSC
Responsibilities:
- Lead, envision, and plan CRSC projects; provide scientific expertise and oversight for clinical/regulatory and public-facing medical writing across programs/therapeutic areas.
- Serve as lead SME for design, planning, authoring, editing, and review of accurate, clear, high-quality medical documents (e.g., lean writing, health literacy).
- Collaborate with cross-functional teams; apply critical thinking, problem solving, and negotiation skills; act as escalation point for issues impacting timelines, quality, or compliance.
- Identify/lead initiatives to improve medical writing processes/standards; advise on MW tools/technology platforms.
- Apply deep expertise in clinical development and global regulations/disease areas/products; provide regulatory strategy and trend insights.
- Provide scientific/operational mentorship, coaching, and/or oversight to other medical writers.
- May manage direct reports (workload, professional development, performance management).
Qualifications:
- Bachelor’s degree or higher in a health/scientific/relevant discipline; 7+ years relevant medical writing/industry experience.
- Required: Ophthalmology experience (industry/academia), preferably retinal diseases (AMD, RVO, and/or DME).
Required Skills/Experience:
- Independently lead/manage/author complex clinical regulatory and/or public-facing documents per evolving requirements.
- Critically analyze/present clinical data clearly in line with regulatory guidance.
- Lead multiple deadline-driven projects and teams; strong decision-making, conflict resolution, negotiation, and communication.
- Expert end-to-end drug development/clinical trial process knowledge; interpret/apply ICH (e.g., GCP) and disclosure laws/policies.
- Proficient with MS Office/SharePoint and ability to adopt emerging tech.
Preferred:
- Experience managing direct reports.
Compensation/Benefits & Application:
- Salary range: $173,200.00–$272,600.00; eligible for annual bonus/long-term incentive (if applicable).
- Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate/sick days).
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub); apply by the deadline shown on the posting.
Responsibilities:
- Lead, envision, and plan CRSC projects; provide scientific expertise and oversight for clinical/regulatory and public-facing medical writing across programs/therapeutic areas.
- Serve as lead SME for design, planning, authoring, editing, and review of accurate, clear, high-quality medical documents (e.g., lean writing, health literacy).
- Collaborate with cross-functional teams; apply critical thinking, problem solving, and negotiation skills; act as escalation point for issues impacting timelines, quality, or compliance.
- Identify/lead initiatives to improve medical writing processes/standards; advise on MW tools/technology platforms.
- Apply deep expertise in clinical development and global regulations/disease areas/products; provide regulatory strategy and trend insights.
- Provide scientific/operational mentorship, coaching, and/or oversight to other medical writers.
- May manage direct reports (workload, professional development, performance management).
Qualifications:
- Bachelor’s degree or higher in a health/scientific/relevant discipline; 7+ years relevant medical writing/industry experience.
- Required: Ophthalmology experience (industry/academia), preferably retinal diseases (AMD, RVO, and/or DME).
Required Skills/Experience:
- Independently lead/manage/author complex clinical regulatory and/or public-facing documents per evolving requirements.
- Critically analyze/present clinical data clearly in line with regulatory guidance.
- Lead multiple deadline-driven projects and teams; strong decision-making, conflict resolution, negotiation, and communication.
- Expert end-to-end drug development/clinical trial process knowledge; interpret/apply ICH (e.g., GCP) and disclosure laws/policies.
- Proficient with MS Office/SharePoint and ability to adopt emerging tech.
Preferred:
- Experience managing direct reports.
Compensation/Benefits & Application:
- Salary range: $173,200.00–$272,600.00; eligible for annual bonus/long-term incentive (if applicable).
- Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate/sick days).
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub); apply by the deadline shown on the posting.