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Sr Spec, Medical Writing, Clinical Science (Remote, USA) - Transcatheter Mitral and Tricuspid Therap

Edwards Lifesciences Corp
William Penn Annex West, PA
Closing date
Jan 17, 2022

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Science, Pharmaceutical, Medical Writer
Organization Type
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The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization. As a key member of the Clinical Science, Medical Affairs team, the Senior Specialist is responsible for providing scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies for a dynamic portfolio of products across TMTT. The Senior Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. Note: This position is internally titled as a Senior Specialist, Medical Affairs and is an individual contributor (SME) role. Job Description Summary Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Essential Job Functions/Key Responsibilities: * Author clinical evaluation plans (CEPs), clinical evaluation reports (CERs), pre- and post-market clinical trial protocols, Clinical Study Reports, Annual Progress Reports (APRs), regulatory responses, and other scientific documents * Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders * Conduct literature searches and reviews, including developing search strategy, manage associated documentation, and prepare literature summaries * Act as a Clinical Science representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies * Lead 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 * Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Minimum Requirements: * Bachelors Degree in related field and 5 years of previously related experience in medical writing * Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel * Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills * Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing * 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 * 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 Preferred Qualifications: * Familiarity with the coronary interventional and structural heart environments and current treatment options or have other clinical and/or clinical trial experience * Experienced in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations * Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously * Excellent oral and written communication skills Additional Talents and General Expectations: * Summarize key clinical evidence from published literature and provide updates to internal stakeholders (as appropriate) * Correctly analyze clinical data/results and interpret outcomes to propose appropriate follow-up * Ensure documents comply with regulatory guidelines * Works independently without close supervision * Compares and evaluates possible courses of action after considering various possibilities * Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met * Considers the cause and effect of activities Determines or effectively recommends course of action after considering potential risks of alternatives * May provide guidance to lower level personnel * Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment * Direction tends to be high level and focused on end results with means of accomplishment left to incumbent 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 $99,000.00 to $116,000.00. Additional information can be found through the link below: Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards 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 or have a valid religious or medical exemption from being vaccinated.

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