New · posted Oct 22
Merck · Pharmaceuticals
Director, Clinical and Regulatory Strategic Communications
- North Wales, PA
- On-site
- Full-time
- Director
Closes Nov 1, 2026 · 10 days left
The role
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.
What you need
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.
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
Travel Requirements
10%
Preferred skills & experiencenice to have
- Experience managing direct reports
clinicaltrialjobs
Pay and benefits
$173,000 – $273,000 a year
Employer providedAdditional 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
Medical, dental, vision insurance
Retirement benefits including 401(k)
Paid holidays
Vacation
Sick and compassionate days
Annual bonus and long-term incentive
Where you'll work
North Wales, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in North Wales, PAWorking conditions
1st - Day
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
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. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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. Please click here if you need an accommodation during the application or hiring process.
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:
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.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in the US106 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $173,000 | — | $273,000 |
| All US (middle half) | $211,375 | $235,750 | $264,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 315 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Documentation and SOPs10
- GMP and compliance5
- Regulatory submissions2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Merck on Regulatory Jobs
- 17
- Open roles
- 17
- Distinct roles
- 6
- Locations
By discipline
- Regulatory11 65%
- Quality5 29%
- Compliance & Safety1 6%
By level
- Director9 53%
- Senior & Principal3 18%
- Associate & Specialist3 18%
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Director, Clinical and Regulatory Strategic Communications at Merck
Applications close November 1. $173K–$273K a year, employer provided.