FSP Senior Medical Writer

About ExecuPharm:

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Position Purpose:

The Senior Medical Writer (Sr MW) writes/edits clinical study reports, study protocols, investigator’s

brochures, clinical data summaries, and other documents for submission to the Food and Drug

Administration (FDA) and other regulatory authorities; and develops abstracts, manuscripts, and

presentation materials summarizing clinical data.

Organizational Relationships:

• Reports to ExecuPharm assigned Line Manager with day-to-day direction from the Client.

• Liaises with cross functional lines/vendors as appropriate.

Primary Duties:

• Write/edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries,

and other medical/regulatory documents

• Develop manuscripts and presentation materials

• Develop and manage timelines for document development

• Coordinate multi-document projects

• Represent medical writing on study teams and cross-functional strategic teams

• Work on problems of diverse scope where decisions are based upon a mixture of analysis, wisdom,

experience, judgment, and rigorous logic and methods

• Acts independently to determine methods and procedures on new assignments action

• Complete training assigned by Client and/or EP, as necessary, including general training

requirements, SOPs, and system and process related training

• Adhere to EP and Client SOPs and processesQualificationsSkills and Education:

**Plain language writing and ICF experience are a must.

• BA/BS in life sciences and a minimum of 5 years’ experience or MS/PhD and a minimum of 2

years’ experience

• Solid understanding of FDA/ICH guidelines and GCPs

• Experience preparing clinical regulatory documents and scientific publications

• Expert abilities in Microsoft Word, Excel and PowerPoint

• Experience with Adobe Acrobat

• Prior NDA/BLA/MAA submission experience

• Strong written and verbal communication skills

• Ability to coordinate and prioritize multiple projects in a fast-paced environment

• Ability to anticipate and address issues with potential to impact timelinesEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.