Senior Medical Writer - Oncology

Job Description

The Senior Medical Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio.

With minimal oversight, the Senior Medical Writer:

• Demonstrates independence in preparing clinical regulatory documents (e.g., protocols, clinical study reports, investigator’s brochures, clinical sections of submissions) per company and regulatory requirements.

• Applies an in-depth knowledge of medical writing responsibilities, including document planning and authoring, and interpretation of data.

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

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

• Applies critical thinking, problem solving and negotiation skills to identify innovative solutions to challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.

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

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

• May participate in orientation and coaching of junior team members or contract writers.

Education Requirement and skills:

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

• Bachelor’s degree with 5+ years, master’s degree with 4+ years, or doctorate degree with 3+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.

• Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., clinical study reports, investigator’s brochures, clinical sections of submissions) per regulatory requirements and industry guidelines.

• Ability to present clinical data clearly and objectively, with minimal supervision.

• Demonstrated critical thinking and problem-solving capabilities.

• Ability to manage multiple projects in a deadline-driven environment, work collaboratively, and lead authoring 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) and shared document systems (e.g., SharePoint); familiarity with concepts of structured content management preferred.

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R343297