Specialist, Document Disclosure
Specialist, Document Disclosure
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$ 85600 - 134800
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 in public disclosure of clinical trials and their results document disclosure and data sharing with external researchers.
The Specialist provides support to document disclosure group and holds primary responsibility for ensuring the companys compliance with transparency and privacy regulations by collaborating with product development teams to review documents with protected information and redact accordingly.
The responsibilities of the Specialist in Document Disclosure are:
Reviewing and preparing documents to ensure personal protected information is removed.
Facilitating collaborative review with contributing authors and product development team to identify commercially confidential information in documents.
Executing quality checks of documents including the completion of associated justification.
Managing disclosure timelines and participating in submission planning management team meetings.
Monitoring and escalating potential incidences in release of protected information.
Providing input and feedback to the Standard Operating Procedures and Working Instructions for the preparation of documents for public release.
Assist other disclosure efforts and operations (e.g. external data sharing clinical trial application activities).
Qualifications
Bachelors degree in Life Sciences or a related discipline
Required Experience and Skills
Three (3) years of pharmaceutical industry and/or clinical research experience.
Proficiency in the use of a Doc base system or similar Electronic Document Management system.
Experience writing or general understanding of the content of drug and/or device study submission documents.
Knowledgeable in European Medicines Agencys (EMA) and/or Health Canada publication of clinical information requirements.
Preferred Experience and Skills
Highly organized and able to manage multiple projects at any given time.
Attention to detail and dedicated to excellence in all aspects of their work.
Ability to work under pressure while maintaining a positive attitude
Excellent communication and stakeholder management skills.
Able to work independently and collaboratively in a team environment.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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 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:
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$85600.00 $134800.00Available 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 preexisting 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/aJob Posting End Date:
05/8/2025*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:
Unclear Seniority
Employment Type
Full-Time
