Senior Medical Writer

Avania • United States, United States • 1w ago

Avania are hiring - Senior Medical Writer - Medical Devices/clinical trials

About the role

As a Senior Medical Writer at Avania, you will serve as the primary medical writing expert for our North American clients. This role requires you to take ownership of key clinical documentation, including clinical study protocols and clinical study reports, supporting large and complex medical device studies with an emphasis on cardiovascular and related therapeutic areas. You will act as the main point of contact for clients, ensuring clear and professional communication. Collaborating closely with global medical writing colleagues, biostatisticians, regulatory affairs, and consulting teams, you will contribute to the successful delivery of high-quality clinical documents. This position offers the opportunity to work in a dynamic, client-facing environment with a focus on growth and long-term career development

What you'll be doing

Serve as the primary medical writing contact for clients in North America, particularly supporting US-based clients

Develop and deliver high-quality clinical study protocols and clinical study reports, focusing on CRO medical writing deliverables.

Collaborate closely with global medical writing colleagues, biostatistics teams, regulatory affairs, and consulting groups to ensure alignment and quality of documentation.

Manage multiple projects simultaneously, typically handling between five to ten clinical study documents at various stages of development and client review.

Participate actively in client communications, providing expert guidance and support throughout the study documentation process to build strong client relationships.

Candidates who offer any combination of the skills, knowledge and experience listed below, are encouraged to apply, including covering letter for the role of Senior Medical Writer. With our continued growth we are hiring talent to join us on our journey and grow with us.

What we're looking for.

Experience in writing clinical study protocols and clinical study reports for pivotal studies or studies with complex design, demonstrating a strong understanding of CRO deliverables

Comfortable and skilled in client-facing roles, able to communicate effectively and serve as the primary point of contact for clients in North America.

Ability to collaborate closely with cross-functional teams including biostatistics, regulatory affairs, consulting, and commercial groups to ensure high-quality deliverables.

Experience or strong interest in device-related medical writing, with cardiovascular therapeutic area experience considered a significant advantage.

Flexibility to manage multiple projects simultaneously, typically handling between five to ten projects at various stages of development and review.

Strong analytical skills to critically assess study synopses and provide insightful feedback, reflecting a senior-level expertise in medical writing.

Willingness to work hybrid in Toronto or remotely within the US Eastern or Central time zones to facilitate effective collaboration with the team.

What you'll need

Proven experience in medical writing, specifically in developing clinical study protocols and clinical study reports within a CRO environment.

Strong familiarity with regulatory requirements and guidelines relevant to clinical research documentation.

Excellent client-facing skills with the ability to communicate effectively and confidently with stakeholders, including clients and cross-functional teams.

Background in MedTech is preferred, with cardiovascular experience considered a significant advantage.

Ability to manage multiple projects simultaneously, typically handling 5 to 10 projects in parallel.

Comfortable working collaboratively with global teams, including biostatistics, regulatory affairs, and commercial groups.

Flexibility to work hybrid in Toronto, Canada, or remotely within the US, preferably in the Eastern or Central time zones to facilitate team collaboration.

Strong analytical skills demonstrated through the ability to critically assess study synopses and provide insightful feedback.

Masters degree or higher in a relevant scientific discipline; advanced degrees or certifications in medical writing are a plus.

Prior experience in writing for medical device clinical studies is beneficial but not mandatory

We offer -

The opportunity to work in an innovative, fast-growing and rewarding industry

A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties

Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities

Competitive compensation and benefits package (details shared during the interview process)

Some roles offer the opportunities for travel

Ask us about our hybrid and fully remote work opportunities

When you need to advance your career, it takes Avania

We look forward to receiving your application!

Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

LI-DNI

Avania

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