Manager, Medical Writing, Clinical Affairs

28 Mar 2024

Vacancy expired!

Manager, Medical Writing, Clinical AffairsEdwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, with a rapidly growing portfolio of innovative and less invasive solutions.The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis. The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.We have an outstanding, rewarding opportunity for you to join the THV Clinical Affairs team as a Manager, Medical Writing. Acting as primary contact for medical writing projects, and working with other cross-functional Edwards departments, you will provide guidance, develop, and lead medical writing projects, timelines and activities.Key Responsibilities:

Plan, develop and lead the completion of complex medical writing projects in a fast-paced environment with accountability for successful completion within scope of project deliverables including negotiating deliverable timelines, and resolving project-related issues with cross-functional partners (e.g., Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, Biostatistics, etc.)

Act as a technical expert to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g., MDR compliance, etc.)

Provide direction and guidance for smaller projects to execute medical writing projects and/or initiatives. Provide mentoring and knowledge transfer for Medical Writing team members

Act as representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies

Lead the identification, recommendation and implementation of continuous process improvements as it relates to medical writing

Other duties as assigned

Minimum Requirements:

Bachelor's Degree in a related field and 8 years of related experience in medical writing

Master's Degree in a related field and 6 years of related experience in medical writing

Preferred Qualifications:

Class III medical device medical writing experience cardiovascular Class III medical device medical writing experience highly preferred

Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements

Experience writing FDA PMA applications, IDE Progress Reports and documents for PMA post approval requirements;

Experience interacting with Notified Bodies

Medical writing experience specific to regulations within regulatory affairs scope, in medical device

Additional Skills and General Expectations

Ability to discuss complex scientific and technical subjects with stakeholder

Ability to provide leadership and guidance; skilled in coaching and training techniques

Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote) and database systems (e.g., Medline or PubMed)

Extensive editing and prooing skills

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards

Extensive knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques

Extensive understanding of related aspects of the medical writing processes and/or systems

Extensive knowledge on conducting focused searches within medical literature databases (e.g., PubMed, Medline)and ability to evaluate/summarize content

Advanced knowledge of biomedical statistics

Advanced knowledge of US FDA and EU Medical Device Regulation requirements for the submission of pre- and post- market clinical trial data and reports.

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Ability to represent leadership on sections of projects within a specific area interfacing with project managers and cross-functional teams

Ability to consult in a project setting within specific sections

If working on EU MDD and/or EU MDR, CEP/CERs: Extensive knowledge of EU Clinical Evaluation Plans and Reports (CEP, CER, respectively) in compliance with applicable regulations/guidances (e.g., MDD 93/42/EEC as amended by 2007/47/EC, MED DEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG 2020-6) and providing input from the CER into other reports (e.g. clinical evaluation plans and reports, Postmarket Clinical Follow-up Plans and Reports (e.g., MEDDEV 2.12/2, MDCG 2020-7, MDCG 2020-8), Summary of Safety and Clinical Performance (MDCG 2019-9), etc.), including performing literature searches and any other applicable reports

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.The base pay range for this position is $111,000 to $158,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).#LI-REMOTEEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Full-time
  • ID: #49578171
  • State: Colorado Usco 00000 Usco USA
  • City: Usco
  • Salary: USD TBD TBD
  • Showed: 2023-03-28
  • Deadline: 2023-05-28
  • Category: Et cetera