Search suggestions:

hiring immediately
part time
full time
work from home
warehouse
medical assistant
front desk
customer service representative
office assistant
remote
amazon warehouse
receptionist
remote work from home
Los Angeles County
California
Florida
Texas
Houston County
New York
Las Vegas
Kentucky
Indianapolis
Virginia
Ohio
Washington

Principal Medical Writer

Synterex
$146,647 - $199,469 a year
Boston, Massachusetts
Full time
4 days ago

Principal Medical Writer

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 principal medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical and regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.

Location: Fully remote position, preferred ability to attend roundtable meetings on site with clients as requested.

Essential Duties & Responsibilities

  • Provide strategic direction for medical writing projects as the lead writer, including development of submission-level key messages with cross-functional input and creation of project lexicons with harmonized terms
  • Serve as the main point of client contact for issues spanning multiple document types
  • Organize and proactively manage execution of content, timelines, and resources
  • Coordinate activities, provide review, and substantively edit cross-functional team/co-authored contributions
  • Mentor junior writers and develop soft skills needed to successfully navigate team dynamics, comment resolution, and other factors to promote a positive team authoring experience
  • Coordinate internal stakeholder input as well as internal resources (e.g., quality control [QC], publishing)
  • Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document production
  • Plan and lead kickoff meetings and roundtable meetings for each document draft; vet comments following team review to ensure efficient roundtable meetings
  • Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
  • Perform peer QC review as needed
  • Contribute to medical writing operational initiatives (eg, templates, style guides, reference management)

Requirements

  • Experience (10+ years) as a medical writer in the CRO/biotech/pharmaceutical field, or equivalent
  • Advanced degree preferred
  • Oncology experience is a plus
  • Experience as a lead writer for key documents
  • Experiencing successfully managing major submissions
  • Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US/EMA regulatory requirements; working knowledge of other ex-US regulatory requirements is desired
  • Expertise with Microsoft Word and other Microsoft applications
  • Familiarity with document management systems
  • Ability to work both independently and collaboratively in the face of competing priorities
  • Service-oriented and proactive approach to project management
  • Excellent conflict management and negotiation skills
Strong written and verbal communication skills


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.


For further information or to apply, please reach out to [email protected]. 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.

Save Apply
Report job
Other Job Recommendations:

Service Writer/Auto Body Estimator Trainee

Mullikin's Auto Body, Inc.
Easton, Maryland
$18 - $25 an hour
Mullikin's Auto Body, Inc. is looking to add a Service Writer/Auto Body Estimator Trainee to our team. Service Writer/Estimator...
1 week ago

Medical Receptionist/Front Desk

The Genesis Center
Forsyth County, Georgia
$16 - $20 an hour
  • Greet and welcome patients with professionalism and warmth
  • Answer incoming phone calls and address patient inquiries...
1 week ago

Medical Assistant

Sentara
Virginia
$36,950 - $50,467 a year
MJMG Blue Ridge Internal Medicine in Charlottesville, VA is looking to hire a Medical Assistant. The Medical Assistant performs...
2 weeks ago

Orthopedic Medical Assistant

OrthoAtlanta
Sandy Springs, Georgia
$35,733 - $46,325 a year
  • Guiding Patients: Escort patients to exam rooms, assist...
  • Coordinating Care: Prepare surgical orders, schedule lab...
2 days ago

Medical Insuance and A/R Specialist

Tonica Johnson, MD
Durham County, North Carolina
$18 - $22 an hour
  • Process and post payments received from patients and...
  • Follow up on outstanding accounts and manage collections...
2 weeks ago

Social Media/Content Creator/Writer

Heart of the Desert
Alamogordo, New Mexico
$27,886 - $37,872 a year
Also involved are responding to social media inquiries, writing blogs and putting together a quarterly newsletter. After getting...
6 days ago

Medical Director

Theoria Medical
Saginaw County, Michigan
$50,000 - $400,000
  • Pre-Screened Patient Interactions: Virtual care team and APP...
  • Flexible Scheduling: Your schedule, tailored to fit your...
1 week ago

Medical Transportation Driver

Valley View Nursing and Rehab
Boise County, Idaho
$20 - $22 an hour
  • Operate company vehicles in a safe and responsible manner,...
  • Safely assist passengers with boarding and exiting the...
2 weeks ago

Medical Assistant II, Dermatology

Sutter Health
Sacramento County, California
$27 - $33 an hour
  • OR Other: Equivalent Sutter Health Training program...
  • Ability to interpret a variety of data and instructions,...
2 weeks ago