Specialist Disclosure Medical Writer

$83,100 - $130,900/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Entry Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Specialist (Disclosure Medical Writer) in the Medical Writing & Disclosure Department is responsible for preparing clinical study registration and results disclosure postings in compliance with company policies and legal requirements. This role involves authoring scientifically valid disclosures for various clinical trials, collaborating with clinical teams, and ensuring compliance with applicable regulations in both the United States and European Union. The Specialist will also participate in meetings, manage project timelines, and may occasionally prepare lay summaries of trial results.

Responsibilities

• Author scientifically valid clinical trial registration and results postings on ClinicalTrials.gov, EudraCT, and HMA-EMA Catalogue of RWD Studies.
• Prepare study registration and results postings based on source documents, negotiating content with reviewers and guiding the posting through approval.
• Collaborate with clinical teams to ensure compliance with legal requirements for clinical trial disclosures.
• Respond to internal and clinical review comments on public disclosures and amend disclosures as necessary.
• Participate in weekly MW&D-Disclosure meetings and schedule meetings with external teams as needed.
• Inform Project Leads and management of any issues affecting work quality or timelines.
• Gain expertise in regulations associated with clinical study disclosures and adapt to changing regulatory environments.
• Provide feedback on Standard Operating Procedures and Working Instructions as appropriate.
• Occasionally prepare plain language summaries of trial results.

Requirements

• Bachelor's degree in Life Sciences or a related discipline.
• Experience authoring protocol registrations and/or results disclosures on ClinicalTrials.gov or EudraCT.
• Experience in authoring clinical/regulatory documents such as Clinical Study Reports and Protocols.
• Experience in technical or medical writing, with familiarity in clinical research documents preferred.
• Experience in medical publications or regulatory product labeling.

Nice-to-haves

• Good communication and interpersonal skills to interact effectively with stakeholders.
• Strong attention to detail and analytical thinking skills.
• Ability to abstract information from source documents.
• High degree of organization and ability to manage multiple projects simultaneously.
• Demonstrated team skills and ability to work in a cross-functional environment.
• Ability to work under pressure both independently and collaboratively.
• Familiarity with US and/or EU legislation for clinical trial registration and result disclosure.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days