Job Description

• Acquires and applies knowledge and understanding of medical writing responsibilities, including 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).

• Demonstrates growing competence and independence in preparing clinical regulatory (e.g., clinical study reports, participant narratives, investigator’s brochures) and/or public-facing (e.g., clinical trial registration and results postings, plain language summaries, informed consent forms) documents per company and evolving regulatory requirements.

• Is a contributing member on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. Collaborates and negotiates with internal and external stakeholders while planning, authoring, and leading the documents through review and final approval.

• Identifies & proposes solutions to challenges across the scope of work (e.g., documents, content, processes, timelines, tools). Keeps Project Leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.

• Applies developing knowledge of clinical development, relevant regulations, disease areas, and company products.

• Applies developing knowledge of medical writing-specific tools and technology platforms.

• Participates in initiatives to improve medical writing processes and standards.

Qualifications

• Required: Bachelor’s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 years of relevant industry experience.

Required skills & experience

• Knowledge of the principles of clinical research, clinical trial design, and fundamental statistics.

• Strong attention to detail, analytical/logical thinking skills, ability to critically evaluate and interpret data, and problem-solving capabilities.

• Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively within cross-functional teams.

• Strong oral and written communication, interpersonal, and presentation skills in order to interact effectively and tactfully with stakeholders.

• 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

• Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure and with clinical research documents (preferred).

• Technical or medical authoring experience with 1 or more of the following:

• Clinical regulatory documents (e.g., clinical study reports, protocols).

• Protocol registrations and/or results disclosures on public registries.

• Medical publications or regulatory product labeling.

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Preferred Skills:

Current Employees apply

Current Contingent Workers apply

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The salary range for this role is

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

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. 

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