Director Of Medical Writing

This role is with a Phase 1 small CRO and will be direct placement.

Description:

KEY RESPONSIBILITIES

 Writes, reviews, and edits clinical and/or regulatory documents (e.g., protocol, protocol amendments, preclinical and clinical study reports, Investigator’s Brochures, IB addendums, package inserts, clinical and non-clinical modules of INDs, NDAs, and MAAs, Briefing Books, annual reports, DSURs, IMPDs) and other documents in collaboration with cross-functional area teams and per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the National Institute of Health (NIH), and regulatory guidances/standards. 

 May also prepare publications (scientific manuscripts, abstracts, poster presentations, oral presentations).

 Represents medical writing function as an integrated member of clinical study teams. 

 Drives document writing and review processes. 

 Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members 

 Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization 

 Develops and maintains SOPs for the function and writing tools, such as templates and style manuals, and provides training within the department and across departments 

 Performs Quality Control (QC) for all deliverables by self and other medical writers as a critical component of the medical writing process. 

 Identifies recurring QC issues and makes recommendations to line manager for improvement (revisions to SOPs, recommendations for individual training, etc.); implements approved ideas.

 Assigns tasks to other Medical Writers based on each writer’s unique knowledge and skills, while also ensuring appropriate workload distribution in order to meet project deadlines

 Oversees and reviews the work of other medical writers to ensure adherence to SOPs and approved processes; manages outsourced writing projects with contract medical writers as necessary 

 Collaboratively contributes to regulatory medical writing tasks across functional teams and projects, providing relevant guidance and direction for less senior medical writers as needed.

 Develops and drives detailed project timelines according to team-specified deadlines in accordance with current medical writing team processes.

 Works to develop regulatory document templates, formatting, and guidelines for clinical documentation.

 May function as a medical writing liaison between the medical writer team and nonclinical/clinical cross-functional study teams.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.