Specialist Disclosure Medical Writer

MSD; Rahway (NJ); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a detail-oriented Specialist Disclosure Medical Writer to join their Medical Writing & Disclosure Department. This role is pivotal in preparing clinical study registration and results disclosures, ensuring compliance with US and EU regulations. You'll collaborate with diverse teams, author scientifically valid documents, and contribute to health literacy materials. If you thrive under pressure and possess strong communication skills, this opportunity offers a chance to impact clinical development positively while working in a supportive environment.

Qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• Experience in clinical/regulatory document authoring or medical writing.

Responsibilities

• Authoring clinical trial registration and results postings.
• Collaborating with clinical teams for legal compliance.
• Preparing plain language summaries of trial results.

Skills

Clinical trial registration

Results disclosure authoring

Medical writing

Regulatory document authoring

Communication skills

Attention to detail

Organizational skills

Education

Bachelor’s degree in Life Sciences

Job description

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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 (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.

Responsibilities include:

1. Authoring scientifically valid clinical trial registration and results postings on platforms such as ClinicalTrials.gov, EudraCT, and the HMA-EMA RWD Studies registry.
2. Preparing study registration and results postings based on source documents, negotiating content with reviewers, and guiding postings through review and approval.
3. Collaborating with clinical teams to ensure legal compliance with US and EU regulations.
4. Responding to review comments, amending disclosures, and addressing NIH Quality Analysis review comments as needed.
5. Participating in meetings and informing management of issues affecting work completion and quality.
6. Gaining expertise in disclosure regulations in the US and EU, and providing feedback on SOPs.
7. Occasionally preparing plain language summaries of trial results and contributing to health literacy materials.

Qualifications:

• Bachelor’s degree in Life Sciences or related discipline.

Required Experience and Skills:

• Experience authoring protocol registrations and/or results disclosures on ClinicalTrials.gov or EudraCT.
• Experience in clinical/regulatory document authoring or medical writing.
• Experience in medical publications or regulatory product labeling is a plus.

Preferred Skills:

• Strong communication, attention to detail, and organizational skills.
• Ability to work under pressure and in a team environment.
• Familiarity with US and EU clinical trial legislation.

Additional details about benefits, work model, salary, and legal considerations are included in the full description.