Clinical Affairs Senior Specialist, Medical Writing (Remote, Usa)) Surgical Structural Heart (Ssh)

Edwards Lifesciences Corp Hartford , CT 06183

Posted 2 months ago

Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on developing new and maintaining the best standard of surgical and minimal invasive treatments for patients suffering from heart valve disease.

The Clinical Affairs Senior Specialist, Medical Writing will collaborate with internal and external stakeholders to compile, edit, and publish clinical research deliverables. This includes but is not limited to comprehensive clinical study reports, study protocols, annual reports, investigator brochures, informed consent documents, risk/benefit analysis, and integrated summaries from raw data supporting submissions to regulatory agencies.

Key Responsibilities:

  • Develop complex medical writing documents/deliverables, and provide input on templates for assigned project(s)

  • Serve as the medical writing lead for negotiating deliverables, timelines, and resolving project-related issues with cross-functional stakeholders.

  • Work closely with Regulatory, Quality, R&D, clinical professionals and other subject matter experts to support and provide input to Clinical Evaluation Plans and Reports (CEP & CER) to support EU MDD and MDR requirements

  • As necessary, act as medical writing representative in core team meetings providing updates on clinical affairs reports and regulatory submissions (US and international).

  • Support and provide input on other complex cross-functional deliverables (e.g., risk management review, IFUs, SSED) utilizing technical knowledge.

  • Provide leadership, training, and guidance and act as a mentor to less experienced medical writers.

  • Cross-train and provide backup support to regulatory writing team.

  • Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing.

  • Other incidental duties assigned by Leadership

Education and Experience:

  • Bachelor's Degree required post-graduate degree preferred
  • 5 years experience in medical writing or related field

Preferred Qualifications:

  • Experience as a medical writer for cardiovascular or medical device company

  • Formal experience with regulatory medical writing

  • General knowledge of statistical methods/basic biostatistics

  • Ability to read, understand, and compile data from publications, clinical studies, and similar sources of data.

  • Conduct literature searches and reviews, including developing search strategy, manage associated documentation, and prepare literature summaries.

  • 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 proofreading skills

Additional Skills:

  • Excellent written and verbal communication skills including customer negotiating and relationship management skills

  • Excellent problem-solving, organizational, analytical and critical thinking skills

  • Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel

  • Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content

  • Good leadership skills and ability to influence change

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels including internal and external customers

  • Ability to manage competing priorities in a fast paced environment

  • Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

  • Adhere to all EHS rules and requirements 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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Manager Medical Writing (Remote Usa) Transcatheter Heart Valve (Thv)

Edwards Lifesciences Corp

Posted 2 months ago

VIEW JOBS 9/24/2021 12:00:00 AM 2021-12-23T00:00 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 Edwards as an Associate Manager, Medical Writer . You will provide guidance, develop, and lead medical writing projects, timelines and activities. This position is remote and can be located anywhere in the United States. Responsibilities include, but not limited to: * 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 a representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies Minimum Requirements: * Bachelor's Degree in related field with 8 years of related scientific experience OR Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in related field with 6 years of related scientific experience; * Experience as a medical writer * Experience with CERs (Clinical Evaluation Reports) - EU preferred Preferred Qualifications: * Demonstrated ability to discuss complex scientific and technical subjects with stakeholders * Demonstrated 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 proofreading skills * Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives * Experience with PMAs (Pre Market Approvals) - FDA * Experience as a medical writer for cardiovascular or medical device company preferred Additional Talents and General Expectations: * Lead the identification, recommendation and implementation of continuous process improvements as it relates to medical writing For Colorado Residents Only: 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 $117 000 to $137 000. Additional information can be found through the link below: https://www.edwards.com/careers/benefits Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards Lifesciences Corp Hartford CT

Clinical Affairs Senior Specialist, Medical Writing (Remote, Usa)) Surgical Structural Heart (Ssh)

Edwards Lifesciences Corp