Medical Writer, Disclosure

About this role

Job Description

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trials Operations creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials. • Acquires and applies knowledge and understanding of medical writing responsibilities, including design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy).

• Demonstrates growing competence and independence in preparing clinical regulatory (e.g., clinical study reports, participant narratives, investigator’s brochures) and/or public-facing (e.g., clinical trial registration and results postings, plain language summaries, informed consent forms) documents per company and evolving regulatory requirements.

• Is a contributing member on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. Collaborates and negotiates with internal and external stakeholders while planning, authoring, and leading the documents through review and final approval.

• Identifies & proposes solutions to challenges across the scope of work (e.g., documents, content, processes, timelines, tools). Keeps Project Leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.

• Applies developing knowledge of clinical development, relevant regulations, disease areas, and company products.

• Applies developing knowledge of medical writing-specific tools and technology platforms.

• Participates in initiatives to improve medical writing processes and standards.

Qualifications • Required: Bachelor’s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 years of relevant industry experience.

Required skills & experience • Knowledge of the principles of clinical research, clinical trial design, and fundamental statistics.

• Strong attention to detail, analytical/logical thinking skills, ability to critically evaluate and interpret data, and problem-solving capabilities.

• Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively within cross-functional teams.

• Strong oral and written communication, interpersonal, and presentation skills in order to interact effectively and tactfully with stakeholders.

• Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.

Preferred skills & experience • Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure and with clinical research documents (preferred).

• Technical or medical authoring experience with 1 or more of the following:

• Clinical regulatory documents (e.g., clinical study reports, protocols).

• Protocol registrations and/or results disclosures on public registries.

• Medical publications or regulatory product labeling.

eligibleforERP clinicaltrialjobs

Required Skills: Adaptability, Adaptability, Analytical Problem Solving, Business Software Applications, Clinical Research, Clinical Study Design, Clinical Trials, Clinical Trials Operations, Cross-Functional Project Management, Data Management, Deductive Reasoning, Ethical Standards, Evaluate Information, File Sharing, Knowledge Sharing, Logical Thinking, Medical Writing, Progress Monitoring, Project Leadership, Project Management, Project Management Leadership, Project Team Management, Project Tracking, Regulatory Compliance, Regulatory Writing {+ 7 more} Preferred Skills:

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. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $96,200.00 - $151,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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