Senior Principal Medical Writer |Remote|

Job highlights
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Responsibilities
The Senior Principal Medical Writer is responsible for writing and leading complex clinical documents and clinical documents for regulatory submissions
Provides scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process
Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area
Interfaces with functional groups (e.g. PK, Toxicology, Regulatory, Statistical Support, Data Management, Clinical) and writers (internal and external vendors) to ensure timely completion of projects that are scientifically accurate and of high quality
Serves as the scientific writing content expert for the department
Addresses and resolves product area issues
Contributes to process improvement activities
Serves as medical writing lead on complex scientific publications or clinical regulatory documents
Leads clinical documents and document teams for regulatory submissions
Provides direction, guidance, and mentoring to medical writers regarding assigned projects, including review of work product
Provides input and feedback to management regarding internal medical writers regarding work
Works closely with the Publications or Regulatory team(s) on document strategies
Implements all activities related to the preparation of scientific publications or clinical regulatory documents
Coaches, mentors, and assists medical writers
May provide guidance to external vendors
Converts relevant data and information into a form that meets clinical regulatory document requirements
Explains data in a manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements
Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects
Arranges and conducts review meetings with the team
Ensures required documentation is obtained
Maintains expert knowledge of US and international regulations, requirements, and guidance associated with scientific publications or clinical regulatory document preparation and submissions
Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively
Learns and applies knowledge of therapeutic area and product to scientific publishing projects
Knowledgeable about the product/disease state and is an expert on clinical documents
Continually trains/is compliant with all current industry requirements as they relate to clinical regulatory submissions
Responsible for effective communication to team members
Communicates deliverables needed, writing process, and timelines to team members
Holds team members accountable to agreed-upon project dates
Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.)
Identifies and resolves conflicts (including document content issues), removes barriers, generates innovative ways to ensure teams achieve project goals
Understands, assimilates, and interprets sources of information
Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables
Verifies that results are consistent with protocols
Confirms completeness of information to be presented
Independently resolves document content issues and questions
Provides project management for writing projects for multiple compounds and/or indications within assigned therapeutic area, including submissions, ensuring accuracy and adherence to timelines and processes
As assigned, mentors and provides guidance to medical writers
Oversees writing projects to ensure timeline completion
Must resolve conflicts, remove barriers, and generate innovative ways to ensure teams achieve project goals
Works directly with team members to develop/implement timelines to meet desired project completion dates
Coordinates activities and communications with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, Safety Team on writing projects/submissions
Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge
Arranges and conducts review meetings with the team
Acts as an interface to resolve issues and questions arising during the writing process
Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with the team to draft responses as necessary
Recommends, leads, and implements tactical process improvements within the department
Leads departmental initiatives
Job description
Job Description

The Senior Principal Medical Writer is responsible for writing and leading complex clinical documents and clinical documents for regulatory submissions. Provides scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with functional groups (e.g. PK, Toxicology, Regulatory, Statistical Support, Data Management, Clinical) and writers (internal and external vendors) to ensure timely completion of projects that are scientifically accurate and of high quality. Serves as the scientific writing content expert for the department. Addresses and resolves product area issues. Contributes to process improvement activities.

Responsibilities:

Serves as medical writing lead on complex scientific publications or clinical regulatory documents.

Leads clinical documents and document teams for regulatory submissions.

Provides direction, guidance, and mentoring to medical writers regarding assigned projects, including review of work product.

Provides input and feedback to management regarding internal medical writers regarding work.

Works closely with the Publications or Regulatory team(s) on document strategies.

Implements all activities related to the preparation of scientific publications or clinical regulatory documents.

Coaches, mentors, and assists medical writers.

May provide guidance to external vendors.

Converts relevant data and information into a form that meets clinical regulatory document requirements.

Explains data in a manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements.

Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects.

Arranges and conducts review meetings with the team.

Ensures required documentation is obtained.

Maintains expert knowledge of US and international regulations, requirements, and guidance associated with scientific publications or clinical regulatory document preparation and submissions.

Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively.

Learns and applies knowledge of therapeutic area and product to scientific publishing projects.

Knowledgeable about the product/disease state and is an expert on clinical documents.

Continually trains/is compliant with all current industry requirements as they relate to clinical regulatory submissions.

Responsible for effective communication to team members.

Communicates deliverables needed, writing process, and timelines to team members.

Holds team members accountable to agreed-upon project dates.

Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).

Identifies and resolves conflicts (including document content issues), removes barriers, generates innovative ways to ensure teams achieve project goals.

Understands, assimilates, and interprets sources of information.

Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables.

Verifies that results are consistent with protocols.

Confirms completeness of information to be presented.

Challenges conclusions when necessary.

Independently resolves document content issues and questions.

Provides project management for writing projects for multiple compounds and/or indications within assigned therapeutic area, including submissions, ensuring accuracy and adherence to timelines and processes.

As assigned, mentors and provides guidance to medical writers.

Oversees writing projects to ensure timeline completion.

Must resolve conflicts, remove barriers, and generate innovative ways to ensure teams achieve project goals.

Works directly with team members to develop/implement timelines to meet desired project completion dates.

Coordinates activities and communications with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, Safety Team on writing projects/submissions.

Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge

Arranges and conducts review meetings with the team.

Acts as an interface to resolve issues and questions arising during the writing process.

Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with the team to draft responses as necessary.

Recommends, leads, and implements tactical process improvements within the department.

Leads departmental initiatives.

This role can be based remotely within the US.