Senior Medical Writer – Clinical Focus

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Key contributor to the creation of various documents across multiple service lines.

• Project manager for smaller initiatives, engaging directly with clients.

• Assist in larger, more intricate projects as part of an extensive delivery team.

• Leverage expertise in clinical regulatory writing to guide teams and support clients in achieving their objectives.

⛳️ Requirements

• Bachelor’s degree required.

• Minimum of 3 years of experience in regulatory writing or comparable experience with clinical documentation.

• Familiarity with regulatory authority guidelines and requirements to lead an internal project team and anticipate the impact of writing conventions on the final product for health authority approval.

• Experience in creating submission-level documents (not required to be a document lead).

• Proficient in developing clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE.

• Intermediate skills in Microsoft Word (editing tools, table creation and modification, and figure insertion) and document management practices.

• Strong knowledge of the document creation process and the drug development lifecycle.

• Capable of synthesizing data from various sources and documents to produce summary reports.

• Ability to conduct and lead a CRM while successfully guiding a project team to consensus.

• Proficient in using logical arguments to persuade others when presenting ideas, while also being receptive to differing opinions.

• Establishes professional relationships with clients to enhance business partnerships and stay updated on industry trends.

• Skilled in identifying and institutionalizing effective work practices to ensure consistency in performance.

🏝️ Benefits

• Option for remote work.

• Flexible time off policy.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement opportunities.

• Retirement plan options.