Job Description

The Principal Medical Writer is responsible for leading medical writing deliverables that support the clinical regulatory writing portfolio. The Principal Medical Writer:

• Independently leads and authors clinical regulatory documents (e.g., protocols, pivotal clinical study reports, clinical sections of submission) per company and regulatory requirements.

• Demonstrates expertise as a subject matter expert in document planning and authoring, and interpretation of data, using own judgment and prior work experience.

• Is recognized as a strong scientific contributor and works collaboratively on cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.

• 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.

• 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, processes, tools) while navigating project team dynamics.

• Demonstrates expertise in medical writing-specific tools and technology platforms.

• Provides leadership in initiatives to improve medical writing processes and standards.

• May provide scientific and operational mentorship, coaching and/or project oversight to support other medical writers.

Minimum required education:

• Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine).

• Bachelor's degree with 7+ years, master's degree with 6+ years, or doctorate degree with 5+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.

Required experience and skills:

• Ability to independently prepare a diverse set of clinical regulatory documents (e.g., study protocols, clinical study reports, clinical sections of submissions) per regulatory requirements and industry guidelines.

• Ability to critically analyze and present clinical data clearly and objectively, without supervision.

• Demonstrated critical thinking and problem-solving capabilities with an ability to innovate and drive change.

• Experience managing complex writing projects and leading project teams of medical writers and cross-functional members.

• Excellent oral and written communication and presentation skills.

• Technical expertise in office applications (e.g., Microsoft Office Suite), shared document systems (e.g., SharePoint) and concepts of structured content management.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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.

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Requisition ID:R325175