Associate Director, Clinical Development Medical Writing (Remote)
Associate Director, Clinical Development Medical Writing (Remote)Date: Feb 8, 2024Location:Hartford, United States, Connecticut, 06101Job Id: 54074Who we areTogether, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThe Associate Director, Clinical Development Medical Writing, provides a significant level of oversight and expert guidance, as well as resource management for the direct medical-writing support given to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation in support of drug development, product registrations, and product marketing.The Associate Director offers clear leadership and extensive accountability, strategic vision, and planning direction at the therapeutic-area level (may multiple therapeutic areas) for clinical regulatory documents, and ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards. The Associate Director provides mentoring and proficiency to medical writers preparing any document type.Travel Requirements:
International and domesticRELOCATION ASSISTANCE IS NOT AVAILABLEWORK VISA SPONSORSHIP IS AVAILABLEHow you’ll spend your dayPrimarily work on the multiple product/program levelManage direct reports; contingent workers and/or vendors and provides training to othersStrategically analyze needs to manage resources. Manages/mentors for all document typesWrite and edit clinical regulatory documents (all types)Ensure that documents include the proper context and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adheres to applicable regulatory guidelines and departmental and editorial standardsLead/recommend the preparation/revision of document templatesFormulate strategy under guided supervision; demonstrates "big picture" perspective leveraging experience to recommend strategiesTackle difficult problems; makes decisions and troubleshoots in ambiguous situationsDrive communication toward common understanding and actionable results; proficient in negotiation skills; and conceptualizes and leads initiatives within functionLead development of process, and preparation/revision of SOPs and guidance documentsManage and delivers assignments with quality and within timelinesParticipate in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans.Your experience and qualificationsMaster's degree in life sciences or related scientific discipline with at least 7 years of pharmaceutical industry regulatory writing experience. (CSRs, protocols and IBs.)Enjoy a more rewarding choiceWe offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.Reports ToTherapy Area Head, Medical WritingAlready Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.Important notice to Employment Agencies - Please Read CarefullyTeva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.