Senior Medical Writer

Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!

How you'll make a difference?

The Senior Medical Writer is a highly dynamic role in which the Senior Medical Writer will work in a team environment to help develop global evidence-based clinical strategies for Orthopedic medical devices (Spine) by creating clinical documentation that systematically synthesizes information from multiple data sources while meeting project deadlines. The Sr. Medical Writer will plan and develop clinical evaluation reports (CERs), clinical evaluation plans (CEPs), post-market clinical follow-up (PMCF) reports and plans, summary of safety and clinical performance brochures (SSCPs) as well as clinical study reports (CSRs) and manuscripts in alignment with applicable internal, clinical and regulatory standards and business needs. This role applies analytical thought processes and a highly methodical clinical evaluation approach to develop benefit/risk profiles for the portfolio spinal fixation devices. The efforts of the Sr. Medical Writer will support international product approval, indication expansion and claim support, and mandated post-market and vigilance requirements.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• Review medical scientific literature, analyzing clinical risk and providing benefit/risk assessment, write, review, and edit CERs to comply with MEDDEV 2.7/1 revision 4 and the GSPR of the MDR.

• Write and update coherent and convincing clinical documents by organizing and evaluating large amounts of scientific/clinical/medical data and ensuring consistency across documents.

• Prepare and update clinical regulatory documents, according to internal SOPs.

• Review and edit documents for quality, including those authored by others

• Work collaboratively with cross-functional partners.

• Collaborate within the clinical department to develop and maintain medical writing processes and tools

• Create and maintain detailed project timelines, ensuring adherence to deadlines and deliverables.

• Serve as a subject matter expert during internal and external audits

• Assist with other clinical, marketing, and regulatory projects as assigned (including: preparation of OT, IFU and PSUR).

• Acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature, and experiences for a wide variety of medical devices.

• Communicate scientific content in a clear and concise manner.

• Provide guidance, mentorship and training to new incoming and junior team members about procedures and best practices.

• Other duties as assigned.

• Occasional Travel

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• University/College degree in medical or scientific discipline required.

• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices.

Experience, Skills, Knowledge and/or Abilities:

• 5 year's industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/ R&D.

• Knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation, submissions, and reporting.

• A solid understanding of scientific principles and medical terminology including knowledge of clinical research methodologies, therapeutic areas relevant to the industry, and clinical/preclinical data interpretation.

• Excellent technical writing skills.

• Excellent communication skills.

• Strong organizational skills and the ability to manage multiple projects simultaneously are crucial. A Senior Medical Writer should be able to create and maintain project timelines, set priorities, and meet deadlines while ensuring the highest quality of work.

• Excellent attention to detail and accuracy. They should be meticulous in reviewing and fact-checking content to ensure its scientific validity and adherence to guidelines.

• Proficiency in using industry-standard software and tools, including Microsoft Office Suite, reference management software, and electronic document management systems.

• Must be able to work independently and in a team environment.

• Capable of performing work remotely.

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education:

Masters or Ph.D. preferred.

Experience, Skills, Knowledge and/or Abilities:

N/A

Physical Requirements / Adverse Working Conditions

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

• No additional physical requirements or essential functions for this position.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.