Talent.com
Senior Medical Writer (Remote)

Senior Medical Writer (Remote)

MMSBoston, MA, US
30+ days ago
Job type
  • Full-time
  • Remote
  • Quick Apply
Job description

About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.

With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward.

Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission.

At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit  www.mmsholdings.com  or follow MMS on  LinkedIn .

Responsibilities Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals Complete writing assignments in a timely manner Maintain timelines and workflow of writing assignments Practice good internal and external customer service Highly proficient with styles of writing for various regulatory documents Expert proficiency with client templates & style guides Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects Contribute substantially to, or manages, production of interpretive guides Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary Mentor medical writers and other members of the project team who are involved in the writing process Requirements At least 3 years of previous experience in the pharmaceutical industry Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus Understanding of clinical data Exceptional writing skills are a must Excellent organizational skills and the ability to multi-task are essential prerequisites Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools Experience being a project lead, or managing a project team Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Not required, but experience with orphan drug designations and PSP / PIPs a plus Powered by JazzHR

Create a job alert for this search

Senior Medical Writer • Boston, MA, US

Related jobs
Senior Medical Writer

Senior Medical Writer

Costello MedicalBoston, MA, US
Full-time +1
Quick Apply
You will take a leading role across a variety of medical communication projects, working alongside a team of excellent colleagues to ensure that projects are delivered to an exceptionally high stan...Show moreLast updated: 30+ days ago
  • Promoted
Senior Director, Medical Writing (Hybrid)

Senior Director, Medical Writing (Hybrid)

Vertex Pharmaceuticals IncorporatedBoston, MA, United States
Full-time
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapi...Show moreLast updated: 5 days ago
Senior Medical Writer Job at Synterex in Boston

Senior Medical Writer Job at Synterex in Boston

MediabistroBoston, MA, United States
Full-time
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 seek...Show moreLast updated: 30+ days ago
Senior Medical Writer Job at Costello Medical in Boston

Senior Medical Writer Job at Costello Medical in Boston

MediabistroBoston, MA, United States
Full-time +1
Senior Medical Writers in our Medical Communications team.In this role, you will be at the forefront of our expansion in the US market. This is a unique opportunity to influence and drive change in ...Show moreLast updated: 30+ days ago
Synterex is hiring : Principal Medical Writer in Boston

Synterex is hiring : Principal Medical Writer in Boston

MediabistroBoston, MA, United States
Full-time
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 seek...Show moreLast updated: 30+ days ago
Vertex Pharmaceuticals is hiring : Clinical & Regulatory Medical Writing Senior M

Vertex Pharmaceuticals is hiring : Clinical & Regulatory Medical Writing Senior M

MediabistroBoston, MA, United States
Full-time
General Summary The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases ...Show moreLast updated: 30+ days ago
Senior Director, Medical Writing (Hybrid) Job at Vertex Pharmaceuticals Incorpor

Senior Director, Medical Writing (Hybrid) Job at Vertex Pharmaceuticals Incorpor

MediabistroBoston, MA, United States
Full-time
Overview Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative n...Show moreLast updated: 4 days ago
Vertex Pharmaceuticals Incorporated is hiring : Senior Director, Medical Writing

Vertex Pharmaceuticals Incorporated is hiring : Senior Director, Medical Writing

MediabistroBoston, MA, United States
Full-time
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapi...Show moreLast updated: 4 days ago
Mass General Brigham Health Plan is hiring : Medical Letter Writer in Somerville

Mass General Brigham Health Plan is hiring : Medical Letter Writer in Somerville

MediabistroSomerville, MA, United States
Full-time
Overview The Medical Letter Writer is responsible for independently auditing, editing, composing, and processing adverse determination letters per regulatory standards. The Medical Letter Writer is...Show moreLast updated: 4 days ago
  • Promoted
  • New!
Medical Device Technical Writer

Medical Device Technical Writer

CONFLUX SYSTEMSAuburndale, MA, US
Full-time
Accepting Candidates from MA, NH, VT, ME.Only W2 / No C2C / No Sponsorship.You will translate intricate engineering and clinical concepts into clear, compliant, and user-focused content that meets....Show moreLast updated: 14 hours ago
Principal Medical Writer, Global Medical Writing Job at Deciphera Pharmaceutical

Principal Medical Writer, Global Medical Writing Job at Deciphera Pharmaceutical

MediabistroWaltham, MA, United States
Full-time
Overview Principal Medical Writer, Global Medical Writing – Waltham, MA Be among the first 25 applicants.This is a leadership opportunity for someone with passion and talent in medical writing and...Show moreLast updated: 30+ days ago
  • Promoted
  • New!
Technical Writer (User manuals) - Medical Device

Technical Writer (User manuals) - Medical Device

Infosoft, Inc.Newton, MA, US
Full-time
Technical Writer (User manuals) - Medical Device.This role involves translating complex technical engineering processes and details into clear, accurate, and compliant. We are a global technology le...Show moreLast updated: 6 hours ago
Analyst / Medical Writer

Analyst / Medical Writer

Costello MedicalBoston, MA, US
Full-time +1
Quick Apply
Responsibilities : You will work on projects that involve the detailed analysis and presentation of clinical data, which are instrumental to the successful uptake of novel therapies.Salary : $70,000 ...Show moreLast updated: 30+ days ago
Senior Specialist, Medical Writing Job at Edwards Lifesciences in Boston

Senior Specialist, Medical Writing Job at Edwards Lifesciences in Boston

MediabistroBoston, MA, United States
Full-time
Overview Join to apply for the Senior Specialist, Medical Writing role at Edwards Lifesciences.Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical ev...Show moreLast updated: 4 days ago
Principal Medical Writer, Global Medical Writing Job at Deciphera Pharma in Walt

Principal Medical Writer, Global Medical Writing Job at Deciphera Pharma in Walt

MediabistroWaltham, MA, United States
Full-time
Job Description What’s In It for You : This is an exciting leadership opportunity for a person with passion and talent.The company believes that medical writing is a science that continuously evolve...Show moreLast updated: 30+ days ago
Pharmacovigilance Medical Writer Job at Medasource in Boston

Pharmacovigilance Medical Writer Job at Medasource in Boston

MediabistroBoston, MA, United States
Full-time
Overview An established global biopharmaceutical company is seeking a Pharmacovigilance Medical Writer to support their Medical Safety / Pharmacovigilance team. The writer will focus on safety narrat...Show moreLast updated: 16 days ago
  • Promoted
  • New!
Medical Writer

Medical Writer

Redbock - an NES Fircroft companyBoston, MA, US
Full-time
A leading global manufacturer of cardiovascular medical devices is in immediate need of a remote.This is a 40 hours / week position. The Manager, along with most of the Medical Writing team, is based ...Show moreLast updated: 6 hours ago
  • Promoted
Principal Medical Writer

Principal Medical Writer

SynterexDedham, MA, US
Full-time
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 seek...Show moreLast updated: 30+ days ago