Current jobs related to Manager Medical Writing - Boston - Synterex

  • Director of Medical Writing

    2 weeks ago

    Boston, United States Boston-Based Biotech Full time

    Director of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...

  • Director of Medical Writing

    2 weeks ago

    Boston, United States Boston-Based Biotech Full time

    Director of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...

  • Director of Medical Writing

    2 days ago

    boston, United States Boston-Based Biotech Full time

    Director of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...

  • Director of Medical Writing

    1 day ago

    Boston, United States Boston-Based Biotech Full time

    Director of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...

  • Director/Senior Director, Medical Writing

    4 weeks ago

    boston, United States Meet Full time

    Director/Senior Director, Medical Writing*Remote Opportunity* - hybrid in Boston, MA highly preferred. Remote in EST is also fine.Meet has partnered with an exciting biotech based in Boston, MA that is focused in oncology and immunology. They have a strong development pipeline with programs ranging from P1-P3. They are seeking a Director or Senior Director...

  • Director/Senior Director, Medical Writing

    4 weeks ago

    boston, United States Meet Full time

    Director/Senior Director, Medical Writing*Remote Opportunity* - hybrid in Boston, MA highly preferred. Remote in EST is also fine.Meet has partnered with an exciting biotech based in Boston, MA that is focused in oncology and immunology. They have a strong development pipeline with programs ranging from P1-P3. They are seeking a Director or Senior Director...

  • Director/Senior Director, Medical Writing

    1 month ago

    Boston, United States Meet Full time

    Director/Senior Director, Medical Writing*Remote Opportunity* - hybrid in Boston, MA highly preferred. Remote in EST is also fine.Meet has partnered with an exciting biotech based in Boston, MA that is focused in oncology and immunology. They have a strong development pipeline with programs ranging from P1-P3. They are seeking a Director or Senior Director...

  • Grant Writing Specialist

    4 weeks ago

    Boston, Massachusetts, United States Massachusetts League of Community Health Centers Full time

    Job SummaryThe Massachusetts League of Community Health Centers is seeking a highly skilled Grant Writing Specialist to play a pivotal role in securing funding to support our mission of promoting community health centers and equitable healthcare access.Key ResponsibilitiesDevelop and execute a comprehensive grant writing and acquisition strategy that aligns...

  • Clinical and Regulatory Medical Writing Director

    21 hours ago

    Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job DescriptionVertex Pharmaceuticals is seeking a highly skilled Medical Writing Director to join our team. As a key member of our Medical Writing function, you will be responsible for the management, oversight, operation, and direction of Clinical Regulatory Writing in support of our Pain program.Key Responsibilities:Independently author routine and...

  • Writing Center Director, College of Communication, Boston University

    4 days ago

    Boston, Massachusetts, United States Boston University Full time

    Job Title: Writing Center Director, College of Communication, Boston UniversityThe Boston University College of Communication is seeking a highly qualified and experienced Writing Center Director to oversee the daily operations of the Writing Center and teach media-writing courses to undergraduate and graduate students.Responsibilities:Oversee the daily...

  • Writing Center Director, College of Communication, Boston University

    3 weeks ago

    Boston, United States Association TRENDS Full time

    The Boston University College of Communication (COM) is seeking a Writing Center Director, in the rank of Master Lecturer, to oversee the COM Writing Center and teach media-writing courses to undergraduate and graduate students beginning in the 2025-26 academic year. The Writing Center Director will oversee daily operations of the Writing Center (including...

  • Medical Communications Specialist

    7 days ago

    Boston, Massachusetts, United States Costello Medical Full time

    Job DescriptionCostello Medical is seeking a highly skilled Medical Communications Specialist to join our team in Boston. As a Medical Communications Specialist, you will play a critical role in developing and implementing effective communication strategies to support the launch of novel therapies and devices across a wide range of disease areas.Key...

  • Middle School Writing Teacher

    4 weeks ago

    Boston, MA, United States Uncommon Schools Full time

    Company Description Uncommon Schools is a nonprofit network of high-performing, public charter schools providing an outstanding K-12 education in historically under-resourced communities. We have proudly built schools that reflect our student population, with more than 60% of our teachers and staff across our network identifying as a person of color....

  • Medical Writer

    7 days ago

    Boston, United States Flywheel Partners Full time

    DESCRIPTIONTraining + Communications + Healthcare.We have an immediate opening for a full-time, medical/scientific Writer & Content Developer for Medical/Pharmaceutical/Biotech education. This position is remote/work-from-home.We're looking for highly motivated individuals who feel constrained and uninspired in their current role and are ready for...

  • Medical Content Developer

    7 days ago

    Boston, Massachusetts, United States Flywheel Partners Full time

    About Flywheel PartnersFlywheel Partners is a fast-growing medical education agency that supports top healthcare companies by developing innovative medical and scientific educational content.We work with pharmaceutical, medical device, and biotech companies to create effective engagement with healthcare providers.About the RoleWe are seeking a highly...

  • Medical Assistant

    5 days ago

    Boston, Massachusetts, United States Tufts Medical Center Full time

    Job Title: Medical AssistantThis role is a vital part of our healthcare team, providing support to our medical staff and patients in a fast-paced outpatient setting.Job Summary:As a Medical Assistant, you will be responsible for ensuring the smooth flow of patients through our clinic, providing administrative and clinical support to our medical staff, and...

  • Medical Assistant

    2 days ago

    Boston, Massachusetts, United States Tufts Medical Center Full time

    Job DescriptionJob SummaryTufts Medicine is seeking a highly skilled Medical Assistant to join our team. As a Medical Assistant, you will play a vital role in providing exceptional patient care and supporting our healthcare team.ResponsibilitiesControl and monitor patient flow to maximize efficient use of providers and exam rooms.Prepare medical records for...

  • Medical Assistant

    3 days ago

    Boston, Massachusetts, United States One Medical Full time

    About UsOne Medical is a leading healthcare provider dedicated to delivering exceptional patient experiences. Our mission is to transform healthcare by making quality care more affordable, accessible, and enjoyable.The OpportunityWe are seeking a highly skilled Medical Assistant to join our team. As a Medical Assistant, you will play a critical role in...

  • Medical Assistant

    4 hours ago

    Boston, United States One Medical Full time

    About Us One Medical is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this isn’t your average doctor’s office. We’re on a mission to transform healthcare, which means improving the experience for everyone involved - from patients and providers to employers and health...

  • Medical Assistant

    4 days ago

    Boston, United States One Medical Full time

    About UsOne Medical is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this isnt your average doctors office. Were on a mission to transform healthcare, which means improving the experience for everyone involved - from patients and providers to employers and health networks....

Manager Medical Writing

3 months ago

Boston, United States Synterex Full time

Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.

Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The Manager, Medical Writing will report to the Executive Director of Medical Writing and Quality Assurance and will be responsible for the coordination, management, and growth of Medical Writing team members and vendors/contractors. The Manager, Medical Writing will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management, in planning, preparing, oversight, and/or review of high-quality clinical and regulatory documents (protocols, study reports, sections of marketing applications in CTD format, etc.).

This is a full-time position.


Location: Hybrid; must be able to attend occasional client meetings on site as needed


Essential Duties & Responsibilities

  • Manage direct reports, coordinate resources, and develop work plans that align with internal and external goals and timelines
  • Oversee quality output of deliverables delegated to Medical Writing personnel and vendors/contractors
  • Ensure that all clinical regulatory documents:
  • Comply with international, national, and pertinent local regulations
  • Adhere to SOPs and guidance documents (internal and/or external)
  • Are completed according to timelines
  • Liaise with Executive Leadership team to report on and optimize staff utilization and other key performance indicators (KPIs); record and utilize metrics to inform KPIs
  • Support Medical Writing and Business Development leadership in preparation of work orders, budgets, invoicing, and forecasting
  • Coordinate with Business Operations to answer customer inquiries and enhance time reporting processes
  • Provide guidance and leadership for document development for regulatory writing deliverables, including organization, content, and resource requirements
  • Ensure quality and consistency of style, format, and content for all documents
  • May assist in the planning, writing, and assembly of clinical protocols and amendments, clinical study reports, summaries of safety/efficacy, other regulatory documents (annual reports, briefing documents), safety reports, patient narratives, and investigator brochures/updates as needed

Requirements

  • Undergraduate degree in a scientific or health-related field required
  • Minimum 3 years of clinical research/drug development experience in biotech, pharmaceutical, or contract research organization (oncology experience a plus). Equivalent experience in a related medical field is acceptable.
  • Experience managing diverse teams preferred
  • Team-oriented, self-motivated, assertive, self-confident, and capable of working under minimal supervision
  • Ability to assess and coordinate resources and work effectively across multi-disciplinary work teams
  • Exceptional communication and interpersonal skills
  • Excellent organizational and project management skills to coordinate resourcing across multiple projects
  • Experience with regulatory documents (Module 2 summaries, IND, MAA, annual reports, ISE & ISS); writing nonclinical reports and tabulated summaries a plus
  • Proficient with Microsoft Word, Excel, Project, and PowerPoint
  • Working knowledge of GCP, 21 CFR, CTD, ICH guidelines/regulations, and the drug development process is required

For further information or to apply, please reach out to careers@synterex.com. If anyone tries to contact you that does not come from a synterex.com email address or our HR system BambooHR, please delete and disregard the message as phishing scams are at an all-time high.


Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.