Job Information
Actalent Medical Writer in Lexington, Massachusetts
Pharmaceutical company seeking an experienced Medical Writer with both clinical and regulatory writing expertise.
Applicants must be located on the East Coast
Position Summary:
The Medical Writing Consultant will work with the clinical and regulatory teams to prepare regulatory submissions, protocols including synopses and amendments, schematics, study reports, investigator brochures, annual safety reports, and IND/IMPD clinical sections in CTD format under strict timelines, as needed.
Responsibilities:
Ensure efficient formatting of documents, ensure a consistent style of presentation to maintain quality and ease of review across multiple reviewers.
Contribute to overall project management and cross functional working groups as needed to facilitate efficient development and finalization of documents.
Support the development of the annual medical writing timeline to ensure IB and other pertinent documents are updated as necessary.
Work with CROs to ensure study related documents are completed efficiently as needed.
Participate in the clinical sub-team.
Other duties and responsibilities as required.
Additional Skills & Qualifications:
Bachelor's Degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred
8+ years Medical Writing experience
Sponsor experience
Rare disease experience preferred
Experience with global submissions preferred
Ability to work in a fast-paced environment and meet timelines
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.