Medical Writing Manager


Duration - 6 Months, Contract, W-2


Location - REMOTE


Pay - $55 - $59.82


Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives.


Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.


The Medical Writing Manager will provide guidance, develop, and lead medical writing projects, timelines and activities.


Duties:


* 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


Qualifications and Skills:


* Bachelor's Degree in a related field and 8 years of related scientific experience OR Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in a related field and 6 years of related scientific experience


* Recent experience as a medical writer for a medical device company (class II or III) required; cardiovascular medical device company highly preferred



* Must be well versed in the EU MDR process



* Extensive experience authoring EU Clinical Evaluation Plans and Reports (CEP, CER, respectively) in compliance with applicable regulations/guidance's (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); Post market 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.); Any other applicable reports


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



* Ability to discuss complex scientific and technical subje