Remote Senior Medical Writer

My client is a boutique professional services company focused on R&D services and solutions for the pharmaceutical, biotech, and medical device industries.  They have retained us on the newly created full-time Sr. Medical Writer position.

Job Description:

In this newly created role, you will lead and grow the R&D Medical Writing business unit. While developing high-quality clinical/regulatory medical writing deliverables in support of a clinical program. Analyze proposed plans, programs, individual studies, and related documents and deliver the required information in a compelling fashion with accuracy and consistency in the respective submission documents. 

Responsibilities:

• Lead and develop an existing Medical Writing group.
• Work with managing partners to develop business and grow revenue for the Medical Writing group.
• Build and maintain client relationships and a trusted client partnership.
• Aligning, coordinating, and building consistent messages across individual submission documents for the assigned Client’s Clinical Program:
  • Develops clinical/regulatory content, messaging, logic, and strategies within the clients defined therapeutic area to ensure effective communication in the respective submission documents (i.e. CSR, Protocol, Synopsis, etc)
  • Leads cross-functional / global client teams to develop content/messaging strategy across a program.
  • Works in close collaboration with the Client’s Therapeutic Area leads, Clinical / Safety.
  • Function, Regulatory Function, and other R&D Functions as needed.
  • Develops and drives timelines for Clinical deliverables for global submissions.
• Ensuring the Medical Writing deliverables are complete per client requirements and contract:
  • Ensuring timelines and budget requirements are met per the client contract.
  • Ensuring Client Policies, Procedures, Style Guides, etc., are adhered to.
• Responsible / contributes to the foundation of the Medical Writing Practice through:
  • Drafting internal processes / SOPs.
  • Developing/contributing to Style Guides and Templates.
  • Supporting Business Development and Marketing efforts that pertain to Medical Writing.
  • Attending Medical Writing conferences and meetings.
  • Building an external network pertaining to Medical Writing.

Qualifications:

• Relevant Science Degree Required.
• Post-graduate Science Degree (MS, PhD or MD) preferred.
• A minimum of 10 years of medical writing experience within the pharmaceutical or CRO industry.
• Demonstrated success in 3-5 years in direct management/leading teams.
• Experience in strategic management development, deployment, and execution in leading Medical Writing departments/teams.
• Ability to quickly ramp up and understand respective Therapeutic Areas.
• Ability to drive cross-functional teams.
• Business development experience.
• Solid understanding of drug development, clinical development, and program strategy.
• Solid understanding of global Submission strategy and submission lifecycles (including eCTD).
• Solid understanding of the interconnectivity of messages across individual documents within a clinical program.
• Excellent written, verbal, and presentation skills, with proficiency in the English language.
• Robust MS Office skills, specifically Word functionality (templates, tables, presentations, etc.) and Project.

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