Job Description

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**REMOTE**

The Company

BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

Why Us?

• It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact!
• Everything we do - and we do it with passion - is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
• We're growing, and so will you with leaders who will support your development through mentorship and other opportunities

• Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

The Role

The Senior Medical Writer will operate within the Medical Writing team. Will be required to develop and maintain Quality Control systems and review Clinical Reports for completion, clarity and compliance with different Regulatory authorities. Lead the required update of the medical writing templates. Assist the Junior Medical Writers with the more complex Clinical Reports and conduct training, as appropriate. Note, this role has a strong focus on Phase l studies.

You Will Have The Opportunity To:

• Write and/or review final Clinical Study Report(s) in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, etc.).
• Ensure the writers' compliance with different clients' specifications for all the documents generated by the Medical Writing team.
• Conduct and maintain the required training for junior Medical Writers.
• Assist in the development of the document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
• Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
• Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company's SOP, GCP and other applicable guidelines.
• Conduct all work in compliance with SOP's, GCP and to observe all regulatory guidelines.
• Negotiate timelines with external departments.
• Compile study documents, as required.
• Photocopy and scan study documents.
• Perform other work as assigned.

What You Will Bring:

• Minimum university degree, B.Sc. (i.e. Life Sciences)
• At least 2 years of experience in CRO clinical study report writing in Phase I and Bioequivalence studies (MUST) - indicate on resume
• Good interpersonal and communication skills
• Attentive to details, good initiative and able to work with changing priorities

Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment.

We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs.