Job title: Sr. Medical Writer
Company: Stryker
Job description: Why join Stryker? We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healt
Why join Stryker We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Medical Writer to join our Neurovascular Division to be based in SGTC, Gurgaon, India. Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization will be working to ‘Make Stroke History’. Stroke is devastating 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: . Who we want Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams. Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting. Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. What you will do As the Staff Medical Writer, you will support the Clinical Evidence team within the Clinical Affairs function. You will maintain responsibility for managing several Clinical Science/ Medical Writing deliverables. You will work with confidential company data and will interface with cross-functional internal and external stakeholders. Author clinical trial protocols, interim and final clinical study reports, including Clinical Evaluation Plans and Reports, PMCF Plans and reports, summary of effectiveness and safety integrated safety/performance data summaries Perform formal literature searches, and succinctly summarize scientific content for assigned projects. Contribute to Pre-Submissions, Design and Value dossiers for matrix submissions Contribute to Publications in drafting abstracts, podium presentations and manuscripts Provide clinical science subject matter expertise and consultation to Clinical Research Associates, Biostatistics, Data Management, Regulatory Affairs, Clinical Safety and other internal and external stakeholders. Collaborate with other staff to resolve complex or unclear situations. Propose and participate in departmental continuous improvement initiatives. Assist in training staff. What you need Medical Graduate (MBBS or BHMS) with 6-8 years of experience in Medical devices, Allied paramedical Degree (Nursing, Physiotherapy, pharmacy or biotechnology) with 7-9 years of experience or MD (preferably Anatomy, Pathology, internal Medicine) or DNB (Neuro) with 0-2 years experience or other MD or PhD with allied health sciences with 3-5 years of experience, Other post graduate degree in allied health sciences with 5-7 years experience OR Master’s degree in BioMedical Engineering with 4-6 years of experience Combined experience in medical writing, clinical science in neurovascular or Vascular space will be preferred Strong scientific and medical writing skills required, AMWA, EMWA certifications preferred. Experience in writing CERs, PSURs, Literature summaries, clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses, literature summaries required. Experience in IDE / Class III products/ clinical trials preferred. Must be able to think analytically, have the ability to process scientific and medical data, with the ability to multi-task and problem solve. Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments. Adept at word and power point processing, document management and change control. Excellent working knowledge of regulatory guidelines (FDA/CFR EN540/ Med DEV/ MDCG) and quality standards (ISO14971, ISO 13485, ISO 14155 guidelines is preferred. Know someone at Stryker Be sure to have them submit you as a referralprior to applyingfor this position. 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Expected salary:
Location: Gurgaon, Haryana
Job date: Fri, 11 Feb 2022 23:23:34 GMT
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