Medical Writer

Role overview

An executive search firm is hiring on behalf of a biopharmaceutical company in Summit, New Jersey for a permanent Medical Writer focused on scientific and medical writing. This opportunity is aimed at physicians seeking a career transition or professionals looking to move into a non-clinical path.

Key responsibilities

• Collaborate with the appropriate functional teams to draft clinical and regulatory documents for submission packages, such as investigator brochures, clinical study reports, integrated efficacy and safety summaries, registration dossiers, and responses to health authorities.
• Join study-related and clinical team discussions and help resolve issues connected to document development.
• Assess source data and decide on the best tables, narrative structure, and overall presentation for clarity and logical flow.
• Create document templates that align with FDA, ICH, and electronic submission requirements.
• Plan the document preparation approach, including timelines that meet or surpass company expectations and review workflows.
• Run and support document review meetings and related discussions.
• Contribute to planning for outsourced medical writing work.
• Oversee medical writing assignments handled by external vendors or contractors.
• Check the work of other writers for correctness, quality, focus, and consistency with format and style rules.
• Coach in-house and contract writers on company procedures and document-preparation standards.
• Support the transfer and presentation of clinical and regulatory information to marketing teams for journal submissions.

Skills and knowledge needed

• Strong ability to interpret and evaluate scientific and medical information.
• Advanced command of Microsoft Word and template-based document creation.
• Working knowledge of ICH and health authority requirements for submission documents.
• Background in science or medicine relevant to the role.
• Excellent written and verbal communication skills with strong grammar.
• Comfort using electronic document repositories.
• Awareness of current practices in study reports, international dossier preparation, and eCTD-style electronic submissions.
• Capability to train others in writing and documentation practices.
• Experience collaborating with contract research organizations.
• Ability to manage complex assignments and work effectively across teams.
• Skill in researching internal and external sources such as PubMed, Gen Bank, and the Library of Congress to locate useful reference material.
• Experience preparing a wide range of clinical and regulatory documents.

Application note

Interested candidates were asked to send a CV and cover letter by email so the materials could be forwarded to the executive search firm handling the hiring process.

Additional information

This posting was originally published on March 19, 2009. It also included site navigation, comment prompts, and references to other articles and topics, which are not part of the job requirements.