at Merck in Dover, Delaware, United States
The Medical Writing & Disclosure Department of the GCTO (Global Clinical Trial Operations) 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 (Disclosure Medical Writer) will be primarily responsible for preparing clinical study registration and results disclosure postings in compliance with company policy and country laws and requirements. The disclosure team works collaboratively and independently to prepare disclosure documents for clinical studies in all therapeutic areas.
The Specialist will be responsible for: + Authoring scientifically valid clinical trial registration and results postings on (United States NIH public disclosure registry), the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) registry, and The Heads of Medicines Agencies ( HMA )- European Medicines Agency ( EMA ) Catalogue of Real World Data ( RWD ) Studies (formerly EU PAS ) registry for studies of varying complexity and therapeutic designation.
+ Preparing study registration and results postings based on source documents (e.g., protocols, CSRs), negotiating content with internal and external reviewers, and guiding the 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 Code of Federal Regulations Part 11] in the US, and Directive 2001/20/European Commission 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 addressing NIH Quality Analysis review comments to resolve issues before resubmission when necessary.
+ Participating in weekly MW&D-Disclosure meetings and scheduling meetings as needed with external teams.
+ Assuring that 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 adapting to the changing regulatory environment as needed.
+ Providing feedback on Standard Operating Procedures and Working Instructions as appropriate.
+ As a secondary responsibility, the Specialist may occasionally prepare plain language (lay) summary trial results at a 6-8th grade reading level and provide input into the Health Literate Glossary.
Qualifications + Bachelor's degree in Life Sciences or a related discipline.
Required Experience and skills: AT LEAST ONE of the following or similar: + Experience authoring protocol registrations and/or results disclosures on ClinicalTrials.gov or EudraCT.
+ Experience in authoring International Council for Harmonisation clinical/regulatory documents (i.e., Clinical Study Reports, Protocols, etc.).
+ Experience in technical or medical writing, familiarity with clinical research documents preferred.
+ Experience in medical publications or regulatory product labeling.
Preferred Experience and Skills + Good communication and interpersonal skills (both oral and written) in order to interact clearly, effectively, and tactfully with stakeholders.
+ Strong attention to detail, strong analytical/logical thinking skills; able to critically evaluate data.
+ 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.
+ Ability to work under pressure both independently and collaboratively in a team environment.
+ Work style focused on problem-solving and maximizing accuracy.
+ Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure.
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.
MRLGCTO
#eligibleforerp
MW20
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. 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.
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:
EEOC Know Your Rights ( EEOC KnowYourRights 10 20.pdf)
EEOC GINA Supplement?
Pay Transparency Nondiscrimination ( OFCCP /pdf/pay-transp %20English formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your
To view full details and how to apply, please login or create a Job Seeker account
