Specialist - Clinical Study Disclosure Writer

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.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

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

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

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 separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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Under New York City, 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.

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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:

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Flexible Work Arrangements:

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Requisition ID:R220907