Medical Writing Manager
SUMMARY DESCRIPTION
The , Medical Writing Manager is a subject matter expert at preparing complex clinical and medical writing deliverables. This role is a leader in the medical writing space who authors regulatory and clinical documents in accordance with internal procedures and global regulatory requirements, while leading collaboration with cross-functional stakeholders supporting clinical, regulatory, and business objectives.
REPORTING & MANAGEMENT SCOPE
SUPERVISION RECEIVED:
Reports to the Director of Medical Communications
SUPERVISION EXERCISED:
May mentor, train or supervise junior medical writers.
KEY RESPONSIBILITIES
• Leads and manages their product teams.
• Subject Matter Expert for who excels in identifying pertinent internal and external sources of clinical data.
• Leads product teams for evaluation and documentation of literature searches of peer review publications.
• Reviews, authors and mentors Clinical Evaluation Reports & associated documents in accordance with EU MDR and Integra internal procedures.
• Independently able to interact with regulatory bodies to answer questions as needed.
• Reviews and prepares clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier.
• Reviews and authors clinical study reports, manuscripts for publication, posters, abstracts or internal white papers.
• Forecasts, manages, and meets project deadlines. Takes the initiative to report on project status; anticipates and alerts leadership and internal customers of potential project difficulties.
• Develops tools, templates, best practices and standard operating procedures to ensure efficient preparation of high-quality medical writing deliverables. Ensures template sections of documents remain current and consistent across documents/Business Units as applicable.
• Develops and maintains effective working relationships with co-workers, internal customers, and external vendors.
• Develops/executes publication plans & strategy through the development of high-quality publications, abstracts, posters, and presentations.
REQUIRED SKILLS & MINIMUM QUALIFICATIONS
Education: Master's degree or PhD in a scientific or healthcare discipline preferred
Experience: 10 years in medical device industry with a minimum of 8 years as a medical writer.
Skills: Advanced medical writing, clinical regulatory expert, project management, strong attention to detail, and expert 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.
Salary Pay Range:
$95,000.00 - $130,000.00 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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour 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 Total Rewards | Integra LifeSciences
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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The , Medical Writing Manager is a subject matter expert at preparing complex clinical and medical writing deliverables. This role is a leader in the medical writing space who authors regulatory and clinical documents in accordance with internal procedures and global regulatory requirements, while leading collaboration with cross-functional stakeholders supporting clinical, regulatory, and business objectives.
REPORTING & MANAGEMENT SCOPE
SUPERVISION RECEIVED:
Reports to the Director of Medical Communications
SUPERVISION EXERCISED:
May mentor, train or supervise junior medical writers.
KEY RESPONSIBILITIES
• Leads and manages their product teams.
• Subject Matter Expert for who excels in identifying pertinent internal and external sources of clinical data.
• Leads product teams for evaluation and documentation of literature searches of peer review publications.
• Reviews, authors and mentors Clinical Evaluation Reports & associated documents in accordance with EU MDR and Integra internal procedures.
• Independently able to interact with regulatory bodies to answer questions as needed.
• Reviews and prepares clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier.
• Reviews and authors clinical study reports, manuscripts for publication, posters, abstracts or internal white papers.
• Forecasts, manages, and meets project deadlines. Takes the initiative to report on project status; anticipates and alerts leadership and internal customers of potential project difficulties.
• Develops tools, templates, best practices and standard operating procedures to ensure efficient preparation of high-quality medical writing deliverables. Ensures template sections of documents remain current and consistent across documents/Business Units as applicable.
• Develops and maintains effective working relationships with co-workers, internal customers, and external vendors.
• Develops/executes publication plans & strategy through the development of high-quality publications, abstracts, posters, and presentations.
REQUIRED SKILLS & MINIMUM QUALIFICATIONS
Education: Master's degree or PhD in a scientific or healthcare discipline preferred
Experience: 10 years in medical device industry with a minimum of 8 years as a medical writer.
Skills: Advanced medical writing, clinical regulatory expert, project management, strong attention to detail, and expert 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.
Salary Pay Range:
$95,000.00 - $130,000.00 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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour 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 Total Rewards | Integra LifeSciences
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.
Apply tot his job
Apply To this Job