Principal Medical Writer, Disclosure

Merck•North Wales, PA

2d•$142,400 - $224,100•Onsite

About The Position

The Clinical and Regulatory Strategic Communications (CRSC) department within 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 Principal Medical Writer, Disclosure, in partnership with a project lead, leverages strategic and scientific expertise to develop, author, edit, and lead the review of accurate, clear, and compliant clinical, regulatory, and/or public‑facing documents, across multiple programs and therapeutic areas, in support of the company portfolio.

Requirements

Bachelor’s degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 5 years of relevant medical writing or industry experience.
Experience managing complex writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
Ability to critically evaluate and interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines.
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.
Excellent oral and written communication and presentation skills.
Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.
Clinical Data
Clinical Development
Clinical Study Design
Clinical Trial Compliance
ICH GCP Guidelines
Medical Writing
Regulatory Documents
Regulatory Requirements
Technology Platforms

Nice To Haves

Experience independently authoring scientifically valid public disclosure postings in accordance with global and local disclosure regulations.
Knowledge of disclosure regulatory intelligence and evolving industry trends to assess impact on business activities.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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
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 place, introductions are position specific. Please, no phone calls or emails.
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):
No

Responsibilities

Is recognized as a 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) and evolving regulatory requirements.
Is recognized as a strong scientific contributor and collaborator on cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
Applies critical thinking, problem solving, and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics.
Provides program oversight by keeping project leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.
Demonstrates expertise in medical writing-specific tools and technology platforms.
Leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate.
Applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products. Demonstrates a developing understanding of the pharmaceutical industry beyond clinical research.
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.