Real Estate

Hello Associates,

Any available local consultants for Medical Writer. I have an excellent project with my client at  Boston, MA. 

Kindly share suitable profiles at  faheem@mirthconsulting.net

Job Title : Medical Writer

Location: Boston, MA  - Area (Phone then SKYPE) NO RELOCATION

Duration: 12-18 month ++

Will start remote then move to onsite after COVID-19 is over

VISA: -Citizen, Green Card Only

**No Relocation: Example, if Boston is back open on a Tuesday, consultant must be able to be on site the next day. No time to fly in and find somewhere to stay. Must be local already

**REMOTE but must be within 2 hours drive of Boston. Will need to go onsite occasionally

Description:

Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Independently researches, writes, and edits clinical study reports, study protocols and standard response documents. Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers. Provides senior review of documents and training/mentoring for other writers.

-Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory). Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.

-May manage several long-term projects concurrently.

-Represents Medical Writing in Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations.

-Establishes and develops client relationships; independently initiates and leads interactions with clients.

-Assists with business development and development of budgets and proposals.

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational

qualification; Advanced degree preferred

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to

5+ years') or equivalent combination of education, training, & experience.

Experience working in the pharmaceutical/CRO industry preferred

Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills and Abilities:

-Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills

-Strong project management skills

-Excellent interpersonal skills including problem solving

-Strong negotiation skills

-Excellent oral and written communication skills with strong presentation skills

-Significant knowledge of global, regional, national and other document development guidelines

-In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions,communications, etc.

-Great judgment and decision-making skills

-Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

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Thanks & Regards.

Syed Faheem | Technical Recruiter

6353 N  Claremont Ave Chicago, IL. 60659

Direct: 312-428-5615

faheem@mirthconsulting.net|  www.mirthconsulting.net|

https://www.linkedin.com/company/mirth-consulting-inc