Director, Clinical and Regulatory Strategic Communications

Merck; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Job summary

Merck's Clinical and Regulatory Strategic Communications group seeks a Director who leads scientific writing for clinical regulatory and public-facing documents across programs, applying lean writing and health literacy principles to ensure accuracy, clarity, and regulatory compliance.

The role collaborates with cross‑functional teams, mentors medical writers, manages multiple complex projects to timelines, interprets ICH guidelines, and helps shape regulatory strategy while advancing a culture

Qualifications

• Bachelor’s degree or higher in a health, scientific, or relevant discipline.
• 7+ years medical writing or industry experience.
• Experience independently leading and authoring complex clinical regulatory and/or public-facing documents.
• Ability to interpret regulatory requirements and present data clearly.
• Strong decision-making and leadership across teams.

Responsibilities

• Lead design, planning, authoring, editing, and review of high-quality documents reflecting medical writing best practices.
• Serve as a key scientific contributor and cross-functional team collaborator on projects.
• Apply critical thinking to implement innovative solutions across MW scope of work.
• Act as escalation point for issues impacting timelines, quality, or compliance.
• Mentor and provide oversight for other medical writers; may manage direct reports.

Skills

Medical writing leadership

Cross-functional collaboration

Regulatory writing

ICH GCP knowledge

Editorial review

Project management

Attention to detail

Negotiation

Education

Bachelor’s degree or higher in health/science

Tools

Microsoft Office

SharePoint

Job description

Job Description

The Clinical and Regulatory Strategic Communications department within Global Clinical Trial Operations (GCTO) creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

The Director of Clinical and Regulatory Strategic Communications leads, envisions, and plans projects, engaging strategically with key stakeholders across departments, divisions, and company. The role provides scientific expertise and oversight for the preparation and execution of clinical regulatory and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio.

• Is a lead subject matter expert in the design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy).
• Is a pivotal scientific contributor and key collaborator on cross‑functional teams with demonstrated team and project leadership.
• Applies advanced critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics, external partnerships, collaborations, and key strategic engagements.
• Acts as escalation point for issues that could impact timelines, quality, or compliance.
• Identifies and/or leads initiatives to improve medical writing processes and standards; provides expertise and/or strategic direction for use or development of Medical Writing (MW)-specific tools and technology platforms; may serve as a resource for this work internally and externally, as appropriate.
• Applies deep expertise in clinical development, global and relevant regulations, disease areas, and company products. Demonstrates comprehensive knowledge of the pharmaceutical landscape beyond clinical research and provides insight into regulatory strategy and emerging industry trends.
• Provides scientific and operational mentorship, coaching, and/or project oversight to support other medical writers.
• May manage direct reports including workload, professional development, and performance management.

Required Qualifications

• Bachelor’s degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)
• 7+ years relevant medical writing or industry experience

Required Skills & Experience

• Experience independently leading, managing, overseeing, and/or authoring complex clinical regulatory (e.g., protocols, clinical study reports, key clinical submission documents) and/or public‑facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements.
• Ability to critically analyze and present clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines.
• Strong decision‑making skills. Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
• Experience managing multiple, complex projects in a deadline‑driven environment and leading teams of medical writers and/or cross‑functional team members.
• Demonstrated critical thinking and problem‑solving capabilities with an ability to innovate, influence, and drive change.
• Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making.
• Expert knowledge and thorough understanding of end‑to‑end drug development and clinical research and clinical trial processes.
• Ability to interpret and apply International Council for Harmonisation (ICH) guidance (e.g. Good Clinical Practice (GCP)), global and local disclosure laws, and corporate policies.
• Excellent oral and written communication and presentation skills.
• Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.

Preferred Skills & Experience

• Experience managing direct reports

Preferred Skills

Adaptability, Business Decisions, Collaborative Leadership, Data Analysis, Decision Making, Ethical Standards, ICH GCP Guidelines, Medical Writing, Project Leadership, Project Management, Regulatory Compliance, Regulatory Writing, Stakeholder Management

Clinical Research, Clinical Trials Operations, Technical Knowledge

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$173,200.00 - $272,600.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

11/1/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.