Specialist - Clinical Study Disclosure Writer (REMOTE)

Job Description

The Specialist (Clinical Study Disclosure Writer) role in the Clinical Data Disclosure & Transparency (CDD&T) department will be primarily responsible for preparing clinical study registration and results disclosure postings in compliance with company policy and country laws and requirements. The CDD&T team work collaboratively and independently to prepare disclosure documents for clinical studies in all therapeutic areas.

Under the supervision of the CDD&T Director, the Specialist will be responsible for:

• Authoring scientifically valid clinical trial registration and results postings on www.ClinicalTrials.gov (United States NIH public disclosures), the EU Clinical Trials Register (EudraCT) and The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) (European Union public disclosures) for studies of varying complexity and therapeutic designation
• Preparing study registration and results postings based on source documents (e.g., protocols, CSRs), negotiates content with internal and external reviewers, and leads posting through review and approval
• Collaborating with clinical teams, including requesting necessary data and information, to ensure compliance with applicable legal requirements (Section 801 of the Food and Drug Administration Amendments Act and the Final Rule for Clinical Trials Registration and Results Information Submission [42 CFR Part 11] in the US, and Directive 2001/20/EC and the Clinical Trials Regulation of the European Union)
• Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate and incorporating review findings prior to finalizing for posting on public websites; and responding to NIH QA review comments to resolve issues before resubmission when necessary
• Participating in weekly CDD&T meetings and schedules meetings as needed with external teams
• Assuring Project Leads and management are informed of any problems or unresolved issues that could affect the timely completion of the work or the work quality
• Gaining expertise in the regulations associated with the disclosure of clinical study registrations and results in the United States and European Union and adapt to the changing regulatory environment as needed Providing feedback on Standard Operating Procedures and Working Instructions as appropriate
• As a secondary responsibility, the Specialist will occasionally prepare plain language (lay) summary trial results for a 6-8th grade reading level and provide input into the Health Literate Glossary.

Required Education

• Bachelor's degree in Life Sciences from an accredited four (4) year college plus post-college experience writing technically, and/or handling complex data (see below for a non-exhaustive list of example experience).

Required Experience

• At least one of the following or similar:

• One year experience authoring protocol registration and/or results disclosure on ClinicalTrials.gov or EudraCT
• One year medical writing experience authoring ICH clinical/regulatory documents (i.e., Clinical Study Reports, Protocols, etc.)
• Post-graduate degree in a scientific field
• One or more years' experience in technical or medical writing, familiarity with clinical research documents preferred
• One or more years' experience in medical publications or regulatory product labeling

• Knowledge of ICH and GCP guidelines preferred

Required Skills

• Good communication and interpersonal skills (both oral and written) in order to clearly, effectively, and tactfully interact with stakeholders
• Able to abstract information from source documents
• High degree of organization and ability to manage simultaneous projects
• Demonstrated team skills, professional values and personal skills necessary for effective teamwork, able to work in cross-functional environment
• Strong attention to detail, strong analytical/logical thinking skills; able to critically evaluate data
• Ability to work under pressure both independently and collaboratively in a team environment
• Work style focused on problem-solving and maximizing accuracy

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NOTICEFORINTERNALAPPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$80,320.00 - $126,500.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Learn more about your rights, including under California, Colorado and other US State Acts

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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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Remote Work

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R253225