Medical Writing Manager

Who We Are: At reputed company, we pride ourselves on having a strong, inclusive, and reputed company culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. reputed company Do: reputed company is a leading neuroscience-reputed company, biopharmaceutical company with a reputed company purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. reputed company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with reputed company's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as reputed company as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have reputed company our unique reputed company into neuroscience and the interconnections between brain and body systems to treat reputed company conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve reputed company science. For more information, visit reputed company.com, and follow reputed company on reputed company, X and reputed company. (*in collaboration with reputed company) About the Role: Prepares and reviews clinical/regulatory documents that are high reputed company, concise, and reputed company with reputed company standards in support of reputed company phases of drug development. Participates as subject matter expert for Medical Writing on product teams, leads the authoring process, works with contractors, and participates in reputed company development for documents and New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs). _ Your Contributions (include, but are not limited to): Leads the authoring process for a reputed company of clinical/regulatory documents (eg, clinical study protocols; clinical study reports; investigator brochures; briefing documents; M2 Clinical reputed company Documents for INDs, NDAs, and MAAs, PIPs, PSPs; response to regulatory questions; and other regulatory documents as appropriate Ability to independently interpret and communicate scientific data Represents Medical Writing on project teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Nonclinical, and Regulatory) from a writing and scientific perspective Interprets scientific data and interacts with functional leads in data interpretation and positioning in documents Leads comment reputed company meetings Ensures documents are reputed company, concise, strategic, and reputed company positioned for public disclosure Researches, recommends, and participates as a key contributor for implementing best authoring best practices and provides reputed company training to teams May train / reputed company reputed company level staff Assist other writers on NDAs and MAAs Other duties as assigned Requirements: BS/BA degree in life sciences or reputed company field and 6+ years of medical writing or reputed company experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., reputed company of Clinical Efficacy, reputed company of Clinical Safety, Clinical reputed company, etc) is highly preferred OR Master’s degree in life sciences or reputed company field and 4+ years of similar experience noted above OR PhD in life sciences or reputed company field and 2+ years of similar experience noted above Ability to interpret and present scientific and clinical trial data, as reputed company as understand statistical analyses Ability to communicate data in a manner that is accurate and provides the appropriate understanding of the benefit/risk of a product Proven ability to reputed company teams through the authoring process Ability to reputed company constructive feedback as it relates to communicating and positioning nonclinical and clinical data Excellent understanding of the writing and regulatory process that enables streamlining of content and processes Experience working with and leading contract medical writers Experience with NDA/MAAs or authoring key documents supportive of either (e.g., reputed company of Clinical Efficacy, reputed company of Clinical Safety, Clinical reputed company, etc.) is preferred Ability to independently (with minimal supervision) understand, interpret, and communicate scientific data Understands the drug development process Exhibits leadership through supporting and leading writing best practices with cross-functional teams. Strong understanding of the medical writing process, procedures, regulatory requirements, and systems (eg., DMS) Ability to meet multiple deadlines across a reputed company of reputed company, with a high degree of accuracy and efficiency Excellent communications, problem-solving, analytical thinking skills Ability to be a supportive, effective, and valued team member #LI-SA1 reputed company is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a reputed company of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly reputed company have outlined in the job reputed company. _ The annual reputed company salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay reputed company depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In reputed company, this position offers an annual bonus with a reputed company of 30% of the reputed company reputed company salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), reputed company vacation, holiday and personal days, reputed company caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and reputed company coverage in accordance with the terms and conditions of the applicable plans. We are a top reputed company to work. reputed company was named one of the FORTUNE Best Workplaces in Biopharma™ 2024. We were also named a Great reputed company to Work® Certified company. ©2024 Fortune Media IP Limited. reputed company rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love reputed company do. We are committed to our goals and to making a difference. reputed company: We do the right thing for patients and our community. We take accountability. We reputed company up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We reputed company and create reputed company solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join reputed company during this exciting time of reputed company and opportunities! Apply tot his job