2 days ago

Head of Medical Writing


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Head of Medical Writing

Head of Medical Writing
Head of Medical Writing "Join an organization that brings people together to create new outcomes in health" Nestlé Health Science Bridgewater NJ USA or Nestlé Health Science Epalinges Switzerland Undefined period of time contract at 100% Are you ready to join a transformational company in healthcare As Head of Medical Writing you will lead the medical writing function including writing and/or managing medical writing resources internal and external in support of nonclinical clinical and regulatory documents. These include INDs NDAs IBs clinical protocols consent forms CSRs regulatory briefing documents and any other regulatory submission documents. In addition you may support the writing of abstracts posters and manuscripts. In this role you will collaborate effectively with various functions within the R D organization including clinical development clinical operations biometrics regulatory affairs medical affairs as well as with various other project team members. Finally you will provide technical and operational support to the activities of all medical writing documents. Nestlé Health Science is an innovative and fundamentally different type of company a health science company engaged in advancing the role of nutritional therapy to change the management of health for consumers patients and our partners in healthcare. Nestlé Health Science is accelerating the development of its established portfolio of consumer and medical nutrition brands and is investing in research and partnerships to build a pipeline of truly novel therapeutic nutrition. Our intent is to bring forward nutritional therapies that have proven clinical and health economic value and improve the quality of people's lives. Nestlé Health Science plays a key role in the Nutrition Health Wellness ambition of our parent company Nestlé. We have privileged access to Nestlé's R D network including the Nestlé Institute of Health Sciences a biomedical research Institute established at the same time as Nestlé Health Science in January 2011. With global headquarters in Epalinges Switzerland Nestlé Health Science already employs around 3 000 people. Our portfolio of nutrition solutions diagnostics devices and drugs targets health areas including inborn errors of metabolism paediatric and acute care obesity healthy ageing and gastrointestinal and brain health. Bold collaborative and focused professionals passionate about helping build a transformational company fit well in our organisation. Key responsibilities Lead all medical writing activities for assigned project teams. These include working with cross-functional team members to prepare clinical documents protocols IBs CSRs etc. regulatory submission documents as well as publications e.g. abstracts posters manuscripts . Oversee and manage all medical writing resources including FTE's budget contractors and vendors to ensure appropriate medical writing support is available to project teams. Build and lead a high performing medical writing team. Position medical writing as an integral R D function and keeps Senior Management apprised of Medical Writing contributions and impact. Proactively collaborate with other R D functional groups to assess medical writing needs for projects and plans for appropriate support and resources. Create and champion a framework of medical writing best practices and SOP's and document templates that serve as reference documents for entire medical writing team as well as the entire R D organization to ensure quality and consistency. Required Profile Bachelors Masters or PhD in life sciences or related field or Pharm.D Minimum 10 years of medical writing experience in a drug-development environment or in the pharmaceutical/biotech industry Experience in writing various clinical and regulatory documents including protocols study reports investigator brochures safety updates IND clinical sections or other documents as required as well as participation in submissions to the US FDA NDA BLA and EMA MAA Working knowledge of relevant disease states or ability to synthesize this knowledge as needed via literature mining or interaction with relevant clinical colleagues Excellent time management and document management skills with high proficiency in MS Office and other relevant software and document management systems Detailed knowledge of regulatory requirements EMA/ICH FDA as well as working knowledge of various relevant R D functions such as clinical development biostatistics clinical pharmacology regulatory affairs Proficiency with Adobe Acrobat and Electronic Common Technical Document eCTD templates Strong communicational skill both written and spoken in English Work independently and remotely with matrix and international teams spread out geographically Show us that you have the ability to work in matrix teams and drive document completion within appropriate timeframes by working collaboratively with team members responsible for various document sections. You demonstrate excellent writing skills and ability to cohesively summarize vast amount of information from clinical studies and literature as needed. Your ability to write medical documents independently as well as interpret medical literature independently will contribute to our business performance. If you want to make a difference to our performance apply in English at www.nestle.com/jobs. The Nestlé Group is the world's largest food and beverage company with 89 5 billion Swiss Francs in sales in 2016. It is present in 191 countries around the world has 418 factories and its 328 000 employees are committed to Nestlé's purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and services for people and their pets throughout their lives. Its more than 2000 brands range from global icons like Nescafé or Nespresso to local favorites. Company performance is driven by its Nutrition Health and Wellness strategy. Nestlé is based in the Swiss town of Vevey where it was founded more than 150 years ago. Learn more about our Group and reasons to join us on www.nestle.com.

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