The Senior Manager, Medical Writing, is a key member of the Clinical Development organization responsible for independently authoring, managing, and delivering high-quality clinical documents across all phases of development. In addition to hands-on writing, this role provides strategic input into clinical development and regulatory submissions, leads process improvements within Medical Writing, and oversees external writing resources.

Responsibilities

• Author and manage the development of clinical and regulatory documents including protocols, amendments, clinical study reports (CSRs), investigator brochures (IBs), and at times clinical modules of regulatory submissions.
• Collaborate cross-functionally with Biostatistics, Clinical Operations, Clinical Research, Regulatory Affairs, and other functions to ensure alignment of messaging and data accuracy.
• Manage and oversee work outsourced to contract medical writers and CRO partners, ensuring high-quality deliverables.
• Provide project management oversight for writing deliverables across multiple programs, ensuring timelines and quality expectations are met.
• Drive process improvements, including developing and maintaining document templates, style guides, and best practices.
• Serve as a key partner in clinical development strategy planning, offering insight into document planning, messaging, and content structure.

Qualifications

• Advanced degree (MS, MPH, PhD, PharmD) in life sciences preferred.
• 5+ years of relevant medical writing experience in clinical research, including protocol and CSR writing.
• Strong understanding of ICH guidelines, GCP, and global regulatory requirements.
• Exposure to neuroscience or psychiatry areas is preferred, but not required.
• Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams.
• Experience with document management systems (e.g., Veeva Vault) 
• Proficiency in the Microsoft Office Suite.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. 

#LI-MB1

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.