Senior Medical Writer, Clinical and Regulatory Strategic Communications (CRSC)

The Clinical and Regulatory Strategic Communications (CRSC) 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.

• Demonstrates independence in preparing clinical regulatory (e.g., protocols, clinical study reports, participant narratives, investigator’s brochures) 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.
• Applies an in-depth knowledge and understanding of 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 scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
• Applies emerging critical thinking, problem solving, and negotiation skills to implement solutions to challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics. Keeps medical writing project lead and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.
• Applies knowledge of medical writing-specific tools and technology platforms.
• Participates in or leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate.
• Applies knowledge of clinical development, relevant regulations, disease areas, and company products.
• May help with other departmental needs, such as orientation of new team members or mentoring less experienced writers.
• May manage direct reports, including workload, professional development, and performance management.

Qualifications

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

Required skills & experience

• Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
• Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision.
• Demonstrated critical thinking and problem-solving capabilities.
• Experience with conflict resolution and negotiation in cross-functional teams.
• Ability to adapt to changing project needs and unexpected workload demands to help team succeed.
• Strong 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

Clinical and Regulatory Medical Writer (MW) :

• Experience independently preparing a subset of clinical regulatory documents (e.g., protocols, clinical study reports, participant narratives, investigator’s brochures), in accordance with regulatory requirements and industry guidelines.

clinicaltrialjobs

Required Skills:

Adaptability, Ethical Standards, ICH GCP Guidelines, Medical Writing, Process Improvements, Project Management, Regulatory Compliance, Regulatory Documents, Regulatory Submissions, Technology Platforms

Preferred Skills:

Mentorship, Teamwork, Time Management, Written Communication

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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.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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.