Director, Clinical and Regulatory Strategic Communications

MSD; Guaduas; On-site; COP 550,785,000 - 866,883,000; Full time

Job summary

MSD seeks a Director of Clinical and Regulatory Strategic Communications to lead and shape regulatory communications, provide scientific oversight, and mentor medical writing teams across multiple programs. This role drives compliance, regulatory strategy, and cross-functional collaboration to advance the development portfolio.

The position requires strong leadership, deep knowledge of ICH guidelines, and the ability to manage complex projects in a deadline-driven environment.

Qualifications

• Experience leading complex clinical regulatory documents per regulatory requirements.
• Strong ability to analyze clinical data and present it clearly in line with guidelines.
• Proven leadership across teams and ability to mentor others.

Responsibilities

• Lead, envision, and plan regulatory communications across programs and therapeutic areas.
• Provide scientific oversight for document development and regulatory strategy.
• Mentor medical writers and manage workload and performance.
• Escalate issues that could impact timelines, quality, or compliance.

Skills

Medical Writing

Regulatory Writing

Project Leadership

Project Management

Regulatory Compliance

ICH GCP Guidelines

Stakeholder Management

Data Analysis

Decision Making

Collaborative Leadership

Adaptability

Ethical Standards

Education

Bachelor’s degree or higher in health/science

7+ years medical writing/industry experience

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.

The Director of Clinical and Regulatory Strategic Communications:

• 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

clinicaltrialjobs

Required 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

Preferred Skills:

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 BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.