Sr. Informed Consent Medical Writer
Sr. Informed Consent Medical Writer
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$ 114700 - 180500
1 Vacancy
Job Description
Job Description
The Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance with public disclosure of clinical trials and their results. The Senior Informed Consent Medical Writer is responsible for developing informed consent deliverables per company process and standards ensuring compliance with internal policy regulatory requirements and health literacy principles.
With minimal oversight the Senior Informed Consent Medical Writer:
- Demonstrates independence in managing multiple study-specific informed consent deliverables per company and regulatory requirements leveraging study protocols established templates libraries glossaries and risk language.
- Applies an in-depth knowledge of informed consent medical writing responsibilities including design planning writing editing and review of accurate clear high-quality documents that reflect the principles of health literacy
- Collaborates with protocol authors and clinical teams to ensure comprehensive understanding of required timelines protocol details and study-specific procedures that impact informed consent documents.
- Applies understanding of clinical development study protocols (eg design objectives and study procedures) relevant regulations disease areas and company products.
- Applies critical thinking problem solving and negotiation skills to identify innovative solutions to challenges across the informed consent medical writing scope of work (e.g. documents processes tools) while navigating project team dynamics.
- Applies knowledge of informed consent-specific tools and technology platforms.
- Participates in or leads initiatives to improve informed consent processes and standards
- May participate in orientation and coaching of junior team members or contract writers.
Qualifications
- Degree in a scientific discipline (e.g. life sciences pharmacy medicine)
Experience and Skills
- 5 years of relevant medical writing experience
- Demonstrated experience presenting complex medical concepts in a clear concise and health-literate format; strong knowledge of health literacy principles preferred.
- Ability to prepare with minimal oversight a summary of a clinical trial design objectives and activities for a lay audience per established guidelines and government regulations.
- Ability to manage multiple projects in a deadline-driven environment working both independently and collaboratively with cross-functional teams.
- Demonstrated critical thinking and problem-solving capabilities.
- Ability to meticulously review own work to ensure document quality (eg accuracy completeness reading level grammar and alignment with document requirements)
- Technical expertise in office applications (e.g. Microsoft Office Suite Adobe Acrobat) and shared document systems (e.g. SharePoint); familiarity with medical writing-specific tools / technology platforms preferred.
- Strong communication (oral written presentation) and project management skills.
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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 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 salary range for this role is
$114700.00 - $180500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
RemoteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Adaptability Adaptability Adobe Acrobat Clinical Data Clinical Development Clinical Operations Clinical Research Clinical Study Design Clinical Testing Clinical Trial Compliance Clinical Trial Management Critical Thinking Data Analysis Early Clinical Development Ethical Standards Health Literacy ICH GCP Guidelines Informed Consent Management Process Manufacturing Compliance Medical Writing Motivation Management Multi-Management Project Management Regulatory Compliance 3 morePreferred Skills:
Job Posting End Date:
06/20/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
