Associate Manager Medical Communication

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

KEY RESPONSIBILITIES

• Prepares complex clinical and regulatory deliverables in accordance with internal GSOPs and applicable regulatory guidelines with minimal oversight.
• Authors clinical documentation including Literature Review Protocols and Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance, and Post-Market Clinical Follow-Up Plans and Reports.
• Develops additional deliverables such as clinical study reports, investigator brochures, manuscripts, posters, abstracts, publication plans, and internal white papers.
• Performs and documents methodologically sound literature searches and critically evaluates peer-reviewed clinical data.
• Maintains compliance with European, Australian, Canadian, and U.S. medical device regulatory requirements.
• Partners with subject matter experts and external vendors to develop technical content that meets regulatory and business needs.
• Mentors junior staff and helps develop templates, tools, SOPs, and best practices.  

REQUIRED SKILLS & MINIMUM QUALIFICATIONS

Education: Bachelor’s degree (BA/BS) required; advanced degree (PhD or PharmD) preferred.

Experience: Minimum of 8 years of industry experience (5 years with PhD/PharmD); at least 5 years as a medical writer.

Skills: Advanced medical writing, regulatory knowledge, project management, strong attention to detail, and proficiency with MS Office and reference management tools.

TOOLS AND EQUIPMENT USED

Computers, standard office equipment, Microsoft Office Suite, Adobe Acrobat, document management and reference management systems.

PHYSICAL REQUIREMENTS

Ability to sit and work at a computer for extended periods with visual acuity for detailed document review.

ADVERSE WORKING CONDITIONS

This position does not involve any negative working conditions.

Salary Pay Range:

$82,000.00 - $113,000.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

 

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

 

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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