Senior Medical Writer

Overview:

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

Rho has an excellent opportunity for a highly motivated Senior Medical Writer to join our team! As a Medical Writer, you’ll have the opportunity to work on and manage complex regulatory writing projects.  You will write, edit, and coordinate content for clinical or regulatory projects while serving as the primary technical contact with internal and external teams.

Our Medical Writing Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

• Develop, write and edit regulatory documents including, but not limited to, study protocols, clinical study reports (including safety narratives), informed consent forms, investigator brochures, annual/development safety update reports, IND/IDE components and marketing application modules
• Compile clinical study report appendices and other appendices as needed
• Ensure that regulatory documents are written in compliance with federal law, International Conference on Harmonization (ICH) guidelines, corporate standard operating procedures (SOPs), and project style guide and writing conventions
• Communicate with internal and external teams about document timelines, data analysis/interpretation, and development of documents including coordinating and leading comment resolution meetings with key stakeholders
• Perform editorial and quality control reviews for other authors
• Assist in coordination and management of internal regulatory document review according to SOPs

• BS/BA in a scientific discipline with 4-5 years relevant scientific writing experience or advanced degree with 3 year relevant scientific writing experience; Pharmaceutical industry or Clinical Research Organization (CRO) experience and knowledge of medical terminology preferred and working knowledge of ICH and FDA regulations with the ability to research and review clinical and regulatory content effectively and translate clear and concise messages; strong attention to detail with excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex clinical and statistical data; knowledge of standard editorial/style conventions (e.g., AMA Manual of Style)
• Expert in Microsoft Office and Adobe Acrobat with the ability to use templates and create and manage large electronic files and documents
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $80,000 to $100,000 per year.

EOE. Veterans/Disabled

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